K03 Contract Management Process Updates
K03 Contract Management Process Updates
01.06.2023 11
10.01.2024 12
11.04.2024 13
30.09.2024 14
06.11.2024 15
09.01.2025 16
ko Simulman
Change description
First Issue
Updated Sis and FAQ, Scope of ACS locations added. Process Responisbilities are
added
Matrix for 14000:2015 is added
SIS revised
SIS revised
Valmet Quality Manual is revised for the Manual Revision No: 3.0 release date
11.1.2021 . SIS revised and added
Akasol and Valmet Finland Customer specific requirementsare reviewed
SiS, FAQs revised . Roles and responsibilities corrected
Added special customer requirements - Valmet Supplier Transport Label
Added linkage between CSRs and ACX QMS
SIS added in Matrix with blue color. Customer requirements (from customer Quality
Manuals) is added directly to Matrix. Added linkage between standards and
customer requirement with ACS QMS. Reviewed and added customer
requirements of BornWarner, Valmet and ABB.
Matrix view is changed to the process approach concept. Linkage to the QMS
reviewed, added linkage to Process Cards (PC), Procedures (QP), Quality
Instructions (QPI) and registers (REG). Linkage to customer-specific requirements
also released through process approach concept.
Sweden support functions reviewed. Added (S) to process name to Sweden support
function. Sweden support function removed from policy making. Added internal
documents PC 1-3.1 Strategical Planning and PC 2-3.6 Contract Review (Warranty).
1 R Policy making
Quality objectives
1 R
Environmental Objectives
Risk and opportunity assessment
1 R
1 R Code of Conduct and Sustanability
1 R Leadership
1 R Customer focus
1 R Organizational structure
1 R Process Owners
Management Review
1 R
Contingency plan
1 R
Infrastructure
1 R
1 R Resources
Operational environment
1 R
Communication
1 R
Improvement
1 R
Continuous Improvement
Confidentiality
1 R
1 R IT Management
Statutary and regulatory requirements
1 R Complience obligations
Environmental Aspects
1 R
1 R 5S
Contract Review (S)
1 SR Warranty management (S)
Customer communication
2. Project Management
2
Process Owner: RFQE/PM Manager
RFQ process / Project Management / APQP
2 RT
Program Management
2 RT Customer demand
Purchasing
2 RT Customer satisfaction
4. Product Development
4
Process Owner: Production Manager
Engineering
New Product Introduction (NPI)
Part Approval Process (PPAP)
4 RT
4 RT Planning
Manufacturing Processes
4 R
6 R
7 R
Documentation management
Product documention
Record Retention
9 R
9 R
Incoming Inspection
9 RT
10. Sourcing
10
Process Owner: Sourcing Manager
Supplier quality management
Supplier selection Process
Supplier evaluation and monitoring
10 SRT
11 R
11 R Internal laboratory
11 R External laboratory
ISO9001/IATF 16949/ ISO14001
GeneralBusinessProcessRequirements
ISO 4.1/ ISO 4.2/ ISO 4.3/ IATF 4.3.1/ ISO14001_4.1/ ISO14001_4.2/ ISO14001_4.3
IATF 5.1.1.1
ISO 5.1.1/ ISO14001_5.1
ISO 5.1.2
ISO 5.3/ IATF 5.3.1/ IATF 5.3.2
IATF 5.1.1.3
ISO 9.3/ IATF suppl./ISO14001_9.3
IATF 8.1.2
IATF 7.1.3.1
IATF 4.4.1.1/ ISO 5.1.2/ ISO 8.2.2/ ISO14001_6.1.3/ ISO14001_9.1.2
ISO14001_6.1.2
IATF 7.1.4.1
ISO 8.2.1/ IATF 8.2.1.1/ ISO 8.5.5/ IATF 8.5.5.1 / IATF 8.5.5.2 / IATF 10.2.5
GeneralBusinessProcessRequirements
ISO 8.2.2/ IATF 8.2.2.1/ ISO 8.2.3.1/ IATF 8.2.3.1.1/ IATF 8.2.3.1.2/ IATF 8.2.3.1.3/ ISO 8.2.3.2/ ISO 8
ISO 8.6/ IATF 8.6.1/ IATF 8.6.2/ IATF 8.6.3/ IATF 8.6.4/ IATF 8.6.5/ IATF 8.6.6
IATF 8.5.1.7
ISO 8.1/ IATF 8.1.1/ / ISO 8.5/ IATF 8.5.1/ IATF 8.5.1.3/ IATF 9.1.1.1
IATF 10.2.4
ISO 6.3/ ISO 8.5.6/ IATF 8.5.6.1
GeneralBusinessProcessRequirements
ISO 7.1.2
ISO 7.1.6/ ISO 7.2/ IATF 7.2.1/ IATF 7.2.2/ ISO 7.3/ IATF 7.3.1/ IATF 5.1.1.1/ ISO 5.2.2/ IATF 7.2.3/ IAT
IATF 8.1.2
IATF 7.3.2
GeneralBusinessProcessRequirements
ISO 4.4.1
ISO4.4.2/ISO 7.5.1/ IATF 7.5.1.1/ ISO 7.5.2/ ISO 7.5.3 /IATF 7.5.3.2.2/ IATF 7.5.3.2.1/ IATF 8.5.1.2/ IS
IATF 4.3.2
ISO 6.3/ ISO 8.5.6/ IATF 8.5.6.1/ IATF 8.5.6.1.1/ ISO 8.2.4
IATF 10.2.6
ISO 9.2/IATF 9.2.2.1/ IATF 7.2.3/ IATF 9.2.2.2/ IATF 9.2.2.3/ IATF 9.2.2.4/ ISO14001 9.2.1/ ISO14001_
ISO 8.7.1/IATF 8.7.1.1/IATF 8.7.1.2 /IATF 8.7.1.3/ IATF 8.7.1.4/ 8.7.1.5/ IATF 8.7.1.6/ IATF 8.7.1.7 / IA
GeneralBusinessProcessRequirements
ISO 8.4.1/ IATF 8.4.1.1/ IATF 8.4.1.2/ IATF 8.4.1.3/ IATF 8.4.2.2/ IATF 8.4.2.3/ IATF 8.4.2.4/ IATF 8.4.2
GeneralBusinessProcessRequirements
IATF 7.1.5.3.1
IATF 7.1.5.3.2
Lingake to QMS system CSR BorgWarner
PC 1 Management Process 2
PC 2 Project Management 1
PC 4-3.1 Engineering_NPI 2 X
QP 2.2-1 New product Introduction
QP 4.1-6 Product Stages at Production Line
QP 4.1-7 OEM Tooling
QPI 4.1-1 Handling of samples for ABB Robotics
QPI 4.1-2 Handling of pre-seria for Valmet
QPI 4.1-3 Handling of pre-seria for Gamesa
QPI 4.1-5 Handling of pre-seria for Borg Warner
PC 4-3.3 Planning 0
PC 4-3.2 Production Process 0
PC 4-3.4 Production Development
QP 4.4-2 Technological processes. Support &
Development
QP 4.1-6 Product Stages at Production Line
QPI 4.1-4-5 Used criteria for visual evaluation of
products
QPI 4.1-4-1 Training stages of use measuring means
QP 4.4-1 Calculation of standart time and norms of the
product manufacturing
QPI 4.4-1-1 Rules for measuring time
QP 4.2-3 Calculation of operators working time and
payments rules
PC 6-3.1 Receiving 0
QPI 6.1-1-1V Receiving of components
PC 6-3.2 Storage 0
QP 6.2-2 Visma warehouses
QPI 6.2-1 Storage, inner transfer and packing of
components and ready products
QPI 6.2-1-1 VOLVO CARS package rules
PC 6-3.2.1 UBD process
Automatical UBD register Visma parts
REG_QPI 6.2-1_1 Register of limited term storage
components
REG_QPI 6.2-1_2 Register of parts with special storage
temperature
PC 7-3.1 Recruitment 0
PC 7-3.2 New position implement
PC 7-3.3 Training needs 0
PC 7-3.4 Competence management
QP 7.2-1 Competence
QPI 7.2-1-1 Filling out competency card
QPI 7.2-2 How to oder training
QPI 7.2-3 Internal auditor competency
PC 9.1-3.1 Complaint 2 X
PC 10 Sourcing Management 0
PC 11 Equipment Management 0
X
X
X
X
X
X
X
X
SYS NO IATF 16949
3.1
Terms and
1
definitions for the
automotive industry
4.4.1.2
2
Product safety
6.1.2.3
3
Contingency plans
7.2.3
4 Internal auditor
competency
7.5.1.1
Quality
5 management
system
documentation
8.3.3.3
6 Special
characteristics
8.4.2.1
Type and extent of
7
control -
supplemental
8.4.2.3
Supplier quality
8 management
system
development
8.4.2.3
Supplier quality
8 management
system
development
8.7.1.1
Customer
9
authorization for
concession
7.1.5.3.2.
10
External laboratory
8.5.6.1.1
11 Temporary change
of process controls
5.1.1.2
Process
12
effectiveness and
efficiency
9.3.2.1
Management
13
review inputs –
supplemental
9.2.2.2
Quality
14
management
system audit
3.1
Terms and
15 definitions for the
automotive
industry
9.3.2.1
Management review
16
inputs –
supplemental
6.1.2.3
17
Contingency plans
7.1.3.1
18 Plant, facility, and
equipment planning
8.4.2.4
19
Supplier monitoring
10.2.3
20
Problem Solving
7.2.1
22 Competence –
supplemental
4.4.1.1
Conformance of
23
products and
processes
Annex A: A.1
Phases of the
24
Control Plan
(Notes)
Annex A: A.2
25 Elements of the
Control Plan
IATF copyright
26
notice
REFERENCE SANCTIONED IN
customer requirements
all requirements specified by the customer (e.g., technical, commercial, product and manufacturing p
requirements, etc.)
Where the audited organization is a vehicle manufacturer, vehicle manufacturer subsidiary
specified by the vehicle manufacturer, their subsidiaries, or joint ventures.
Rationale for change:
Customer requirements are developed by vehicle manufacturers for application in their supply chain b
manufacturers are being certified, the vehicle manufactures define how customer approvals and/or in
The organization shall have documented processes for the management of product-safety related pro
following, where applicable:
a) – m) (…)
NOTE: Special approval of safety related requirements or documents may be required by t
approval by the function (typically the customer) that is responsible to approve such docu
Rationale for change:
Clarify any confusion related to special approval review for safety related requirements or documents
The organization shall:
a) – b) (…)
c) prepare contingency plans for continuity of supply in the event of any of the following, but not lim
externally provided products, processes, and services; recurring natural disasters; fire; pandemics (3
technology systems (1); labour shortages; or infrastructure disruptions;
d) include, as a supplement to the contingency plans, a notification process to the customer and othe
impacting customer operations;
e) periodically test the contingency plans for effectiveness (e.g. simulations, as appropriate);
for cybersecurity: (3) testing may include a simulation of a cyber-attack, regular monitorin
of vulnerabilities. The testing is appropriate to the risk of associated customer disruption;
Note: cybersecurity testing may be managed internally by the organization or subcontract
f) conduct contingency plan reviews (at a minimum annually) using a multidisciplinary team including
g) document the contingency plans and retain documented information describing any revision(s), inc
h) include in contingency plans the development and implementation of appropriate emplo
The contingency plans shall include provisions to validate that the manufactured product continues to
which production was stopped and if the regular shutdown processes were not followed.
The organization shall use a multidisciplinary approach to establish, document, and implement its pro
customer and the risk analysis performed by the organization, and shall include the following:
a) documentation of all special characteristics in the product and/or manufacturing documents d
control plans, and standard work/operator instructions; special characteristics are identified with spec
in the manufacturing documents which show the creation of, or the controls required, for t
Rationale for change:
Clarifies the documentation of special characteristics in the product and/or manufacturing drawings.
The organization shall have a documented process to identify outsourced processes and to select the
processes, and services to internal (organizational) and external customer requirements. The process
controls and development activities based on supplier performance and assessment of product, mate
Where characteristics or components “pass through” the organization’s quality managem
the appropriate controls are in place at the point of manufacture.
Rationale for change:
Clarify the organization’s responsibilities for pass through characteristics
The organization shall require their suppliers of automotive products and services to develop, implem
of (1)
eligible organizations (2) becoming certified to this Automotive QMS Standard.
Using a risk-based model, the organization shall define a minimum acceptable level of QM
certified to ISO 9001, unless otherwise Unless otherwise (1) authorized by the customer [e.g.
level
of development. Based on current performance and the potential risk to the customer, the
progression: with the ultimate objective of becoming certified to this Automotive QMS Sta
should be applied to achieve this requirement:
a) compliance to ISO 9001 through second-party audits;(1)
b) certification to ISO 9001 through third-party audits; unless otherwise specified by the customer, su
maintaining a third-party certification issued by a certification body bearing the accreditation mark of
Arrangement) member and where the accreditation body’s main scope includes management system
c) certification to ISO 9001 with compliance to other customer-defined QMS requirements (such as Min
[MAQMSR] or equivalent) through second-party audits;
d) certification to ISO 9001 with compliance to IATF 16949 through second-party audits;
e) certification to IATF 16949 through third-party audits (valid third-party certification of the supplier t
NOTE: The minimum acceptable level of QMS development may be compliance to ISO 9001 through s
Rationale for change:
(1) Clarified the expected supplier quality management system development progression. This approa
the standard.
(2) Additional clarification added with “as applicable” in the first paragraph to address tho
including but not limited to the following: scrap metal suppliers, trucking companies who
The organization shall obtain a customer concession or deviation permit prior to further processing wh
approved.
The organization shall obtain customer authorization prior to further processing for “use as is” and re
subcomponents are reused in the manufacturing process, that sub-component reuse shall be learly co
Rationale for change:
Clarify requirements and eliminate contradiction in relation to customer approval associated with rew
External/commercial/independent laboratory facilities used for inspection, test, or calibration services
perform the required inspection, test, or calibration, and either:
— the laboratory shall be accredited to ISO/IEC 17025 or its national equivalent (e.g.,CNAS-CL01
(International Laboratory Accreditation Forum Mutual Recognition Arrangement– www.ilac
calibration service in the scope of the accreditation (certificate); the certificate of calibration or test re
— where an non (5) accredited laboratory is not available utilized (5) (e.g. for example, bu
parameters with no international traceable standard reference,(4) or original equipment m
evidence that the laboratory has been evaluated and meets the requirements of Section7.
— there shall be evidence that the external laboratory is acceptable to the customer. NOTE
or by customer-approved second-party assessment that the laboratory meets the intent o
performed by theorganization assessing the laboratory using a customer-approved metho
manufacturer when a qualified laboratory is not available for a given piece of equipment.
Section 7.1.5.3.1 have been met. Use of calibration services, other than by qualified (or cu
confirmation, if required (3, 4)
Note: integrated self-calibration of measurement equipment, including use of proprietary
Rationale for change:
Some organizations found the lab accreditation requirements for external/commercial/independent la
services confusing and needed clarification. Clarified lab accreditation requirements and expectations
1 Issued April 2018
2 Revised June 2018
3 Reissued to show that the note and subsequent paragraphs were not excluded.
4 Clarified conditions under which a non-accredited laboratory may be used, where the original equip
selfcalibration (April 2021). Also deleted the sentence about regulatory confirmation since that is not
The organization shall identify, document, and maintain a list of the process controls, including inspec
control and the approved back-up or alternate methods. The list of process controls shall i
methods, if back-up or alternate methods exist.
Rationale for change:
Clarified that not every primary process control has a back-up or alternate method. Clarified that if a
included on a list maintained by the organization. It is not a requirement to have an alternative proc
Top management shall review the product realization processes effectiveness and efficiency o
improve their effectiveness and efficiency the organization’s quality management system. T
management review (see Section 9.3.2.1.).
Rationale for change:
Clarified that not every process requires an efficiency measure. The organization needs to determine
system. Additionally, the organization’s problem-solving processes need to have an effectiveness revi
Input to management review shall include:
a) cost of poor quality (cost of internal and external nonconformance);
b) measures of process effectiveness;
c) measures of process efficiency for product realization processes, as applicable;
d) product conformance;
e) assessments of manufacturing feasibility made for changes to existing operations and for new
facilities or new product (see Section 7.1.3.1);
f) customer satisfaction (see ISO 9001, Section 9.1.2);
g) review of performance against maintenance objectives;
h) warranty performance (where applicable);
i) review of customer scorecards (where applicable);
j) identification of potential field failures identified through risk analysis (such as FMEA);
k) actual field failures and their impact on safety or the environment.
Rationale for change:
Clarified that not every process requires an efficiency measure. The organization needs to determine
system.
The organization shall audit all quality management system processes over each a three-year audit
approach to verify compliance with this Automotive QMS Standard. Integrated with these audits, the o
for effective implementation.
The complete audit cycle remains three years in length. The quality management system a
cycle, shall be based upon internal and external performance and risk. Organizations shall
processes are required to be sampled throughout the three-year audit cycle and audited t
base requirements, and any customer-specific requirements.
Rationale for change:
Clarified that the audit cycle remains three years in length. Deleted IATF 16949 FAQ 18 and put forme
be audited during the three-year audit cycle.
embedded software
Embedded software is a specialized programme stored in an automotive component (typic
customer, or as part of the system design, to control its function(s). To be relevant in the
software must be developed for an automotive application (i.e., passenger cars, light com
achieving and maintaining IATF Recognition, 5th Edition, Section 1.0 Eligibility for Certifica
NOTE: Software to control any aspect of the manufacturing process (e.g., machine to manu
embedded software.
Rationale for change:
Minimize confusion regarding embedded software and what is applicable.
Deleted IATF 16949 FAQ 10.
Input to management review shall include:
a) cost of poor quality (cost of internal and external nonconformance);
b) measures of process effectiveness;
c) measures of process efficiency for product realization processes, as applicable;
d) product conformance;
e) assessments of manufacturing feasibility made for changes to existing operations and for new facil
f) customer satisfaction (see ISO 9001, Section 9.1.2);
g) review of performance against maintenance objectives;
h) warranty performance (where applicable);
i) review of customer scorecards (where applicable);
j) identification of potential field failures identified through risk analysis (such as FMEA);
k) actual field failures and their impact on safety or the environment;
l) summary results of measurements at specified stages during the design and developme
Rationale for change:
In the section “8.3.4.1 Monitoring” the summary results of measurements at specified stages during t
an input to management review; however, it was not displayed in the section 9.3.2.1. Measurements
a) – d) (…)
e) periodically test the contingency plans for effectiveness (e.g. simulations, as appropriate);
cybersecurity testing may include a simulation of a cyber-attack, regular monitoring for sp
vulnerabilities. The
testing is appropriate to the risk of associated customer disruption;
Note: cybersecurity testing may be managed internally by the organization or subcontracted as appro
Rationale for change:
Combined with SI 3, since that is for the same IATF 16949 clause
The organization shall use a multidisciplinary approach including risk identification and risk mitigation
designing plant layouts, the organization shall:
a) optimize material flow, material handling, and value-added use of floor space including
control of nonconforming product; and
b) facilitate synchronous material flow, as applicable; and
c) implement cyber protection of equipment and systems supporting manufacturing.
Rationale for change:
Cybersecurity is not limited to the support functions and office areas using computers. Manufacturing
to cyber-attack. This addition drives the implementation of necessary protections to ensure continued
The organization shall have a documented process and criteria to evaluate supplier
performance in order to ensure conformity of externally provided products, processes, and
services to internal and external customer requirements.
At a minimum, the following supplier performance indicators shall be monitored:
a) delivered product conformity to requirements;
b) customer disruptions at the receiving plant, including yard holds and stop ships;
c) delivery schedule performance;
d) number of occurrences of premium freight.
If provided by the customer, … in their supplier performance monitoring:
e) … f)
Rationale for change:
Premium freight is already included as part of the Customer Satisfaction requirement defined in 9.1.2
outside the scope of the organisation’s quality management system as this is an internal supplier perf
The organization shall have a documented process(es) for problem solving, which prevent(s)
recurrence, including:
a) defined approaches for various types and scale of problems (e.g., new product development, curre
b) containment, interim actions, and related activities necessary for control of nonconforming outputs
c) root cause analysis, methodology used, analysis, and results;
d) implementation of systemic corrective actions, including consideration of the impact on similar pro
e) verification of the effectiveness of implemented corrective actions;
f) reviewing and, where necessary, updating the appropriate documented information (e.g., PFMEA, co
Where the customer has specific prescribed processes, tools, or systems for problem solving, the orga
the customer.
Rationale for change:
Corrective actions are often observed to miss the important step of prevention of recurrence. Preven
The organization shall establish and maintain a documented process(es) for identifyingtraining needs
performing activities affecting conformity to product and process requirements.Personnel performing
satisfaction of customer requirements.
To reduce or eliminate risks to the organization, the training and awareness shall also incl
environments and employees’ responsibilities, such as recognizing the symptoms of pendi
Rationale for change:
Employee knowledge is a key enabler to prevent issues from becoming significant, including identifyin
The organization shall ensure conformance of all products and processes, including service parts and
requirements, including conformance to material requirements (see Section 8.4.2.2).
Rationale for change:
While not a new requirement, material regulatory compliance is becoming an increasingly important area in the automotive se
All other sections of Annex A: A.1 are unchanged
NOTE 1 It is recommended that the organization require its suppliers to meet the requirements of this
NOTE 2 For bulk materials, the control plans do not list most of the production information. This inform
NOTE 3 For highly automated processes (e.g., semiconductors, machining, welding) where the control method (i.e., spec
controlled by a system (e.g., MES - Manufacturing Execution System or similar), summary control information is accep
information.
Rationale for change:
Documenting all controls of highly automated and complex processes (such as semiconductor fabrication, some machining or w
Allowing reference and/or linkage to the system controlling the process removes potential for outdated information and errors
A.2 Elements of the Control Plan
A control plan includes, at a minimum, the following contents:
General data
a) control plan number;
b) issue date and revision date, if any;
c) customer information (see customer requirements);
d) organizations name/site designation
e) part number(s) or common control plan designation
f) part name/description;
g) engineering change level;
h) phase covered (prototype, pre-launch, production);
i) key contact
j) part/process step number;
k) process name/operation description;
l) functional group/area responsible.
All other sections of Annex A: A2 (Product control, Process control, Methods and Reaction plan) are unchanged.
Rationale for change:
Common control plans used for multiple parts can result in a list of covered part numbers that is too large to include in the Co
This Automotive Quality Management System Standard, known as IATF 16949, is copyright protected
Automotive QMS Standard “IATF 16949” is a registered trademark of the IATF.
Except as permitted under the applicable laws of the user's country, neither this Automotive Quality
retrieval system or transmitted in any form or by any means, electronic, photocopying, recording or o
Reproduction may be subject to royalty payments or a licensing agreement and violators are subject
Requests for permission to reproduce and/or translate any part of this Automotive QMS Standard sho
The Society of Motor Manufacturers and Traders Ltd. Limited (SMMT / UK)
Foreword –
1 Automotive QMS
Standard
Foreword –
2 Automotive QMS
Standar
4.4.1.2
4
Product safety
5.3.1
Organizational roles,
5 responsibilities, and
authorities —
supplemental
7.1.5.1.1
6 Measurement system
analysis
7.1.5.3.2
7
External laboratory
7.5.1.1
Quality management
8
system
documentation
7.5.1.1
Quality management
8
system
documentation
8.4.2.2
Statutory and
regulatory
requirements
9 and
8.6.5
Statutory and
regulatory
conformity
8.4.2.2
Statutory and
regulatory
requirements (cont.)
9 and
8.6.5
Statutory and
regulatory
conformity (cont.
8.4.2.2
Statutory and
regulatory
requirements (cont.)
9 and
8.6.5
Statutory and
regulatory
conformity (cont.)
8.7.1.7
11 Nonconforming
product disposition
8.7.1.7
11 Nonconforming
product disposition
8.7.1.7
11 Nonconforming
product disposition
4.4.1.2
13
Product safety
4.4.1.2
13
Product safety
7.1.5.3.2
14
External laboratory
8.3.2.3
Development of
15
products with
embedded software
8.4.2.4.1
16
Second-party audits
8.5.6.1.1
17 Temporary change of
process controls
9.2.2.3
19 Manufacturing
process audit
9.2.2.4
20
Product audit
8.6.2
Layout inspection
21
and functional
testing
9.2.2.4
22
Product audit
8.5.1.3
23 Verification of job
set-ups
8.4.2.2
Statutory and
24
regulatory
requirements
8.4.2.2
Statutory and
24
regulatory
requirements
8.3
Design and
25 Development of
products and
services
8.5.1.5
26 Total Productive
Maintenance
8.5.1.5
27 Total Productive
Maintenance
9.2.2.3
28 Manufacturing
process audit
6.1.2.3
29
Contingency Plans
6.1.2.3
29
Contingency Plans (Cont )
QUESTIONS AND ANSWER
QUESTION:
Why are there two manuals (IATF 16949:2016 and ISO 9001:2015)? Two manuals instead of
one manual makes it much more difficult to read and understand the requirements.
ANSWER:
The IATF and ISO were not able to reach a licensing agreement to publish IATF 16949 in an integrated
16949 standard, the IATF decided to publish in a two-manual format.
Prior to release, the IATF did confirm with international accreditation organizations that other industry
specific requirements, and auditing with the two-manual model, while not optimal, is effective.The IAT
committee status ensuring continued alignment with ISO 9001.
QUESTION:
Why are the two manuals (IATF 16949:2016 and ISO 9001:2015) so much more expensive than the IS
ANSWER:
Without the co-licensing agreement between ISO and the IATF for the integrated format of IATF16949
standard.The IATF kept the price of the automotive specific content consistent with prior pricing.Essen
ISO 9001.
QUESTION:
What is the scope of this clause? Many organizations focus on regulatory/statutory
requirements of the product and do not believe they have product safety related
manufacturing product or processes.
ANSWER:
This clause focuses on product and manufacturing process characteristics that affect the safety perfor
directly addressed in regulatory/statutory requirements, but may be defined by the customer.
QUESTION:
Is the intent that responsibilities be assigned to the function (e.g. Quality), a specific title (e.g.Quality
ANSWER:
Responsibilities are assigned to the role/position (i.e. specific title, Quality Director) within the organiz
roles, the responsibilities remain with the role (e.g. Quality Director). Therefore, top management will
individuals by name.
QUESTION:
Are MSA studies required for each instrument or device?
ANSWER:
No. A complete statistical study on each single piece of equipment is not required.
Instruments with the same characteristics (e.g. measurement range, resolution, repeatability, etc.) ca
family) can be used for the statistical study.
QUESTION 1:
When can the equipment manufacturer be used to calibrate inspection and test equipment?
If an accredited laboratory exists but is very remote and/or expensive and the inspection or test equip
they are not
accredited to ISO/IEC 17025)?
ANSWER 1:
The inspection or test equipment manufacturer developed the methodology to maintain and adjust
the equipment to meet calibration requirements as part of the design and manufacture of the
inspection or test equipment. Therefore, the original equipment manufacturer of the inspection and te
and manufactured.
The organization shall obtain customer approval before using any original equipment man
QUESTION 2:
If the organization has inspection, measuring and test equipment in the final assembly and test area,
ANSWER 2:
No. In-line measurement and test equipment used in any part of the manufacturing process or assem
QUESTION:
Does the document (which could be a table, list or a matrix) have to include non-IATF
OEMs and Tier 1s? Do all customer requirements beyond CSR’s need to be included in
the document?
ANSWER:
The organization is responsible for evaluating customer requirements, including customerspecific requ
quality management system, per IATF 16949, Section 4.3.2.
A document (which could be a table, a list or a matrix) is required as part of the quality
manual, per IATF 16949, Section 7.5.1.1 d). The document shall include all direct customers of the cer
and other automotive customers (i.e. tier-1, tier-2, etc.).
For example, a tier-2 organization must consider the customer requirements, including
customer-specific requirements, of all its customers. The Tier-2 organization does not
need to consider the customer requirements of the automotive OEM if the OEM is not
its direct customer. It is important to note that the non-IATF OEM customers and other automotive cus
that is shared with their suppliers (e.g. such as a supplier quality manual) or in a specific document av
Identifying customer-specific requirements may be difficult if the non-IATF OEM or other automotive c
requirement documents. A way to identify if any customer-specific requirements exist is to compare s
the customer » exists and verify if the existing customer requirement document lists any specific requ
standard. If yes, that customer and their requirements should be added to the document (which could
Organizations are not expected to take the customer’s requirements, including customerspecific requ
IATF 16949 clauses similar to what has been published by the IATF OEMs.
QUESTION 1:
What is the perspective (on statutory and regulatory conformity)? What is considered
sufficient evidence of conformity to applicable statutory and regulatory requirements (8.6.5)?
ANSWER 1:
As defined in 8.3.3.1 g) and 8.3.4.2, the organization is required to have an approach to research, ide
with the statutory and regulatory requirements for the product they are manufacturing in the country
where they are shipping the products to.
The intent of 8.4.2.2 is that the organization designs into their product development
methodology/business process(es) and their supplier management methodologies/business
process(es), one or more approaches for obtaining confirmation and evidence from their suppliers
that the products and services being provided by the supplier comply with the statutory and
regulatory requirements of the country where the supplier is manufacturing them, the country where
the organization is using them, and the country where the organization ships their product to, if provi
The intent of 8.6.5 is to require the organization to check the records of conformance/compliance rece
comparable traceability
information for the product are covered by the evidence provided by the supplier. This could be done
but must be done prior to release of the product into the organization’s production flow.
QUESTION 2:
Did the intent of clause 8.4.2.2 change from ISO/TS 16949 to IATF 16949?
ANSWER 2:
The intent of the clause did not change. The ISO/TS 16949 requirement was “All purchased product sh
this “passive voice” wording, the IATF decided their expectations were not clear. The new requiremen
what evidence is required to support compliance.
QUESTION 3:
How do you manage and maintain current knowledge of statutory and regulatory
requirements for international suppliers?
ANSWER 3:
IATF 16949, section 8.6.5, does not require the organization to be aware of or keep a list of all the inte
provided processes, products or services they purchase. The organization is required to review the res
process is robust and assures compliance with the latest applicable statutory, regulatory and other re
customer-identified countries of designation.
QUESTION 4:
How can our system comprehend the statutory and regulatory requirements if they are not communic
ANSWER 4:
The clause as worded expects the customer to provide information to the organization of where the
products are going to be shipped. Changes to the applicable statutory and regulatory requirements
due to changes in these destinations are only a requirement to the organization “if provided” by the c
QUESTION 1:
What is the intent and requirements for “rendering unusable” prior to disposal? When and where does
ANSWER 1:
The intent is to ensure that the product cannot find its way into the unofficial aftermarket, onto a road
The process of rendering nonconforming product unusable, does not have to occur in the manufacturi
disposal.
QUESTION 2:
How does the organization control this?
ANSWER 2:
The organization is responsible to develop and implement a nonconforming product disposition
process and verify its effectiveness.
QUESTION 3:
Can the organization use a service provider to render the product unusable?
ANSWER 3:
Yes, it is acceptable to contract the process of rendering the product unusable to a service provider.
If a service provider is used, the organization needs to approve, and periodically verify, how the
supplier is rendering the product unusable.
QUESTION 4:
Does nonconforming product disposition apply only to final product or does it also apply to componen
ANSWER 4:
This requirement applies to the product that has gone through the part approval process and that the
QUESTION 5:
For rendering unusable, how much damage needs to be done to the nonconforming product?
ANSWER 5:
The nonconforming product needs to be rendered unusable and unrepairable. There is no
requirement for crushing or pulverizing the product into many pieces.
QUESTION:
Is it acceptable to document multiple processes in one “documented process”? Or do they
each have to be individual documented processes?
ANSWER:
Yes, it is acceptable for an organization to group multiple documented processes into one (or more)
processes. Each documented process does not have to be a standalone process. Organizations
should document their processes as it makes sense to their individual business and organizational
needs.
QUESTION:
What are the requirements regarding the levels of training and the particular criteria required
to be identified in relation to product safety (4.4.1.2)?
ANSWER:
As with all personnel competency requirements, the people assigned to specific tasks need to be
competent for that task. That competence needs to include the rules and regulations associated
with the task.
The safety requirements in 4.4.1.2 are very specific as to what is required. The sections include,
referring to IATF 16949 section 4.4.1.2:
a) suppliers are expected to be aware of all statutory and regulatory requirements associated with
the markets for use of the parts, as identified by the customer. The supplier needs to know where
to research the regulations for all affected countries or regions.
b) Customer specifics will identify any customer notification requirements; therefore, knowledge in
customer specifics (which may be taught by an internal designated subject matter expert).
c) The special approvals for design FMEAs would be identified in customer specifics, see item b)
above.
d) and e) The identification of product safety related characteristics and their controls would be
defined by the customer in its definition of special characteristics and required controls. The
personnel developing PFMEAs and Control Plans would need to be knowledgeable in those areas
of their customer(s) documents.
Each line item f) through m) can also be similarly analyzed to determine the level of training and
source of that training for each requirement within the safety requirements.
Since many of the requirements depend upon customer specific requirements, there is no single
complete industry training on this topic. The organization needs to review the customer and
regulatory requirements associated with each of its parts appropriate for the intended country of
use and safety-related part characteristics.
Some customers may have specific requirements regarding product safety, training, knowledge,
and personnel. It is the organization’s responsibility to understand their customer’s specific
requirements related to product safety.
QUESTION:
Is it required that the calibration certificate or (test) report of an external laboratory bears the mark (o
accredited the laboratory to ISO/IEC 17025?
ANSWER:
Yes, only certificates of calibration or test reports including the mark of a national accreditation body
The accreditation mark (often also called “accreditation logo” or “accreditation symbol”) of a national
inspection, test, or calibration services were performed according to the accreditation scope and that
to supervision of a national accreditation body.
QUESTION:
What is the acceptable method to assess a supplier’s software development capability?
ANSWER:
The intent of IATF 16949, Section 8.3.2.3 is to apply the same level of rigor to the development ofsoft
parts, software has defined performance, operating conditions, known inputs, specified outputs, param
(if any), known failure modes, usage profiles, variability of conditions of operation, etc. The planning,
phases in the development of software are not very different in concept from the development of hard
all necessary steps have been taken to design, verify, and produce hardware parts that continue to m
steps are not the same for the development of software. Therefore, a different set of criteria are used
not included in IATF 16949; therefore, other methods are referred to, such as Automotive SPICE and C
some customers. Each customer may have a preferred tool to assess supplier software development c
the acceptable assessment tool. Each customer may also specify a different approach used (e.g., cust
of both). The role of the IATF 16949 internal or external auditor is not to have the knowledge to condu
or external auditor should beт familiar enough with the assessments to be able to recognize when a s
are corrective action plans in place, with the appropriate resources assigned. The IATF 16949 internal
that software development assessment and how that is documented.
QUESTION:
If there is low risk with an organization’s supplier(s), are 2nd party audits required? What
is the intent?
ANSWER:
The risk-based thinking approach, driven by ISO 9001:2015, needs to be incorporated for supplier ma
on the results of the risk assessment (see below), then a 2nd party audit may not be required. To sup
as: supplier certification status, commodity complexity, new product launch(es), significant employee
requirements, and other risks to the organization or to their customer(s).
QUESTION:
Does there have to be an alternative process control for each primary control specified in the
control plan?
ANSWER:
No, it is not a requirement to have an alternative process control for every primary control. When intr
primary control potentially failing and, based on risk and severity of failure mode, decide where altern
process controls are needed, then both the primary and alternative process controls should be define
plan, and the standardized work available. For existing processes, where there is a failure in the prima
process control is defined, the organization should consider risk, (e.g. FMEA) and if approved, develop
controls, verify effectiveness through daily management, and then revalidate when the primary contr
Periodically, the organization shall review instances of where alternative process controls have been u
and control plan. (See SI 11)
QUESTION:
For each manufacturing process audit do all shifts have to be covered?
ANSWER:
Each audit does not have to cover all shifts in one audit (for example an audit of the pressing process
and then in year 2 or 3 an audit undertaken on the third shift for pressing). However, all manufacturin
frequency depending on risk, performance, changes etc.
QUESTION:
Why is there no defined audit frequency for Product audit?
ANSWER:
The audit frequency must be determined based on the risk and product complexity (See ISO 9001, Se
QUESTION:
If first-off/last-off part validation is not performed or appropriate for a specific type of manufacturing p
ANSWER:
As stated in 8.5.1.3 d), first-off/last-off part validation is performed only when it is applicable and appr
applicable or appropriate, there is no requirement to maintain records.
QUESTION 1:
If the organization is not responsible for product design and is therefore only manufacturing
products as per the customer´s design, is the organization then exempt from the
requirements in 8.4.2.2?
ANSWER 1:
No, all organizations regardless of their responsibility for product design must satisfy the applicable re
purchased products, processes, and services for which the organization is responsible.
QUESTION 2:
Is the organization required to request a complete list of countries of destination from the customer if
ANSWER 2:
Yes, the organization is required to request a complete list of the countries of destination from the cus
NOTE:
o The “country of receipt” is where the organization is located.
(Country of the manufacturing site)
o The “country of shipment” is the customer’s receiving location.
(Country where the manufacturing site ships to)
o The “country of destination” is the country where the vehicle is sold.
(Country where the final product is initially sold)
QUESTION 3:
What is the consequence if the customer does not provide the information on the countries of destina
document in this situation?
ANSWER 3:
If the organization claims that the customer did not provide the necessary information on the
countries of destination, the organization should be able to produce written evidence (e.g. letters,
emails, meeting minutes, etc.) of their efforts to obtain it.
QUESTION 4:
What level of detail should be provided by the customer regarding the countries of
destination? Would a generic statement like “every country globally” be an appropriate
response?
ANSWER 4:
No, a generic statement such as “every country globally” is not acceptable. The customer is expected
vehicle(s) are initially
sold.
QUESTION 5:
Applicable statutory and regulatory requirements are often linked to the relevant use of a product. So
use. Based on the before mentioned statement, is the customer required to provide the organization w
ANSWER 5:
It is expected that the customer will provide to the organization information of the characteristics
that are relevant for the identification of required controls to meet applicable statutory and
regulatory requirements (e.g. special characteristics)
QUESTION
What constitutes product design responsibility for an organization?
ANSWER
If an organization receives from its customer a fully defined engineering specification for the parts it i
design responsible. Where the organization does not receive a fully defined engineering specification
responsible. In all cases, the organization is responsible for manufacturing process design.
QUESTION
What is the intent of including the term “periodic overhaul” in the requirements for Total Productive M
ANSWER
The intent of all the line items in section 8.5.1.5 is to include the minimum steps to maintain manufac
produce product to specification. “Periodic overhaul” is rework of manufacturing tooling and equipme
keep the tooling and equipment in a condition where it can continue to make product to specification,
other similar metrics. Periodic overhaul is already defined in section 3 of the standard: “maintenance
prevent a major unplanned breakdown where, based on fault or interruption history, a piece of equipm
service and disassembled, repaired, parts replaced, reassembled, and then returned to service.” Perh
equipment. Perhaps some ooling is simply replaced with a new tool at the end of its useful life. Howev
usage, time or other known factors. The tooling and
equipment manufacturer would be a good source to determine which factors and to estimate when
such major work needs to be completed. Periodic overhaul or its appropriate equivalent (e.g.
replacement) would need to be accounted for in the steps of the organization’s maintenance plan
QUESTION
What is the intent of using the term “Total Productive Maintenance” for this clause, is there
a connection to the industry term “Total Productive Maintenance”?
ANSWER
The term “Total Productive Maintenance” (TPM) used in the IATF 16949 standard refers to various
similar approaches that focus on proactive and preventive techniques for improving tooling and
equipment reliability through the machines, equipment, processes and employees that add
manufacturing value to an organization. For example, the industry approach for TPM places the
responsibility for routine maintenance, such as cleaning, lubricating and inspection in the hands of
the operators.
Clause 8.5.1.5 of IATF 16949 has some requirements which align with some of the pillars of industry
TPM. However, the individual requirements of 8.5.1.5 [a) through j)] are as stated in IATF 16949.
The use of the term “Total Productive Maintenance” in IATF 16949 gives organizations an
opportunity to adopt the underlying principles of industry Total Productive Maintenance while
meeting the listed requirements of 8.5.1.5 in IATF 16949.
QUESTION What is intended frequency and coverage of Manufacturing Process Audits? ANSWER Eff
continued manufacturing of product meeting customer, statutory and regulatory requirements. Howe
manufacturing processes or aspects of manufacturing processes may need higher frequency of asses
if not defined by the customer, by using the appropriate risk management approach, including cons
Manufacturing processes demonstrated to be low risk by the organization may be audited less freque
are audited within the 3-year audit cycle. Evidence for risk analysis includes continued compliance w
customer, process, and internal requirements). If any one of the relevant requirements is not met,
every 3 years. The 3-year frequency as per clause 9.2.2.3 is a minimum requirement intend
QUESTION
What is meant by the use of the term “cyber-attack” for contingency plan testing?
ANSWER
A Cyber-attack is an attempt to gain illegal access to a computer or computer system for the purpose
of causing damage or harm. A cyberattack is often a deliberate exploitation of weaknesses in the
security of computer systems or networks to gain access to data, alter computer code, logic or data.
These actions may have disruptive consequences that can compromise confidential data and lead
to cybercrimes, such as information and identity theft, automation-caused operational interruptions,
encryption of company critical data or illegal remote controlling of systems or data.
Cyber-attacks and cybercrimes are not always a result of a sophisticated series of actions to guess
passwords using powerful computer programs run by teams of people from a remote location. They
are often actions designed to convince individual persons to release sensitive or private information
through email notes (typically phishing), pretexting (impersonating a trusted person or government
official), phone calls announcing fake emergencies getting personal information, visual reading of
typed passwords, infecting popular websites with malware, text messages with links to sites
installing malware, USB drives left on desks, appearing to be legitimate, which are plugged into PCs,
and theft of discarded materials containing confidential computer information, etc. Additionally, a
cyber-criminal, after gaining access to a company's system, could encrypt company's critical data
and demand a ransom to unencrypt the data.
Also, GDPR (General Data Protection Regulation) in Europe or similar requirements in other regions
specify that organizations are responsible to ensure that personal data retained by the organization
is protected and kept secure at all times, reinforcing the importance of being prepared in the case
of cyber-attacks.
Additional details regarding information technology security techniques is available through ISO/IEC
27001.
QUESTION
What are key steps for developing effective contingency plans?
ANSWER
The organization is required to demonstrate that it has developed and implemented effective conting
customer requirements are met. Key steps to develop an effective contingency plan include:
• Analysis of internal and external risks to all manufacturing processes and infrastructure equipment e
the customer(s) (see IATF 16949, clause 6.1.2.3 a) and c), including SI 3)
Note: the risk analysis typically includes an assessment of the likelihood and potential impact of failur
• Development of contingency plan(s) in the event of the failure of the manufacturing and infrastructu
requirements, including any required notifications to interested parties
• Specific contingency plan alternative measures to ensure continuity of supply, which, for example fo
o Backup infrastructure equipment or contracted services, safety stock, auxiliary sources, etc.
• Evidence of review, and regular testing and validation of the contingency plan measures for
effectiveness, including employee awareness
• Compliance with customer requirements and customer specific requirements
Back to Matrix Clause
Quality Policy
5.2 Policy
ISO 9001
5.2.1 Establishing the quality
policy
ISO 9001 5.2.2 Communicating the
quality policy
ISO 14001
5.2Environmental policy
Quality Objectives
Code of conduct
5.1.1.1 Corporate
IATF 16949
responsibility
Risk and opportunities
6 Planning
ISO 9001 6.1 Actions to address risks
and opportunities
6.1.1
Performance evaluation
9 Performance evaluation
9.1 Monitoring,
ISO 9001
measurement, analysis and
evaluation
9.1.1 General
ISO 9001
9.1.3 Analysis and evaluation
9.1 Monitoring,
ISO 14001 measurement, analysis and
evaluation
9.1.1 General
ISO 9001
7.5.2 Creating and updating
ISO 14001
7.5.2 Creating and updating
Competence
ISO 9001
7.2 Competence
7.2.1 Competence -
IATF 16949
supplemental
7.2.2 Competence-on-the-job
IATF 16949
training
Improvements
10 Improvement
ISO 9001
10.1 General
ISO 9001
10.3 Continual improvement
Change management
ISO 9001
6.3 Planning of changes
5S
7.1.4.1 Environment for the
IATF 16949 operation of processes —
supplemental
Environmental aspects
ISO 14001
6.1.2 Environmental aspects
Operational environment
ISO 14001 8.1 Operational planning and
control
Description
tem
4.4.1 The organization shall establish, implement, maintain and continually improve a quality manage
the processes needed and their interactions, in accordance with the requirements of this Internationa
The organization shall determine the processes needed for the quality management system and their
the organization, and shall:
a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and related pe
needed to ensure the effective operation and control of these processes;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes achie
results;
h) improve the processes and the quality management system.
Top management shall establish, implement and maintain a quality policy that:
a) is appropriate to the purpose and context of the organization and supports its strategic direction;
b) provides a framework for setting quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality management system.
The quality policy shall:
Top management shall establish, implement and maintain an environmental policy that, within the de
environmental management system:
a) is appropriate to the purpose and context of the organization, including the nature, scale and envi
activities, products and services;
b) provides a framework for setting environmental objectives;
c) includes a commitment to the protection of the environment, including prevention of pollution and
commitment{s) relevant to the context of the organization
d) includes a commitment to fulfil its compliance obligations;
e) includes a commitment to continual improvement of the environmental management system to e
performance.
The environmental policy shall:
— be maintained as documented information;
— be communicated within the organization;
— be available to interested parties.
6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes
needed for the quality management system.
6.2.2 When planning how to achieve its quality objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
The organization shall establish environmental objectives at relevant functions and levels, taking into
organization’s significant environmental aspects and associated compliance obligations, and consider
opportunities.
The environmental objectives shall be:
a) consistent with the environmental policy;
b) measurable {if practicable);
c) monitored;
d) communicated;
e) updated as appropriate.
The organization shall maintain documented information on the environmental objectives
6.2.2 Planning actions to achieve environmental objectives
When planning how to achieve its environmental objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated, including indicators for monitoring progress toward achievemen
environmental objectives {see 9.1.1).
The organization shall consider how actions to achieve its environmental objectives can be integrated
business processes.
The organization shall define and implement corporate responsibility policies, including at a minimum
an employee code of conduct, and an ethics escalation policy ("whistle-blowing policy").
When planning for the quality management system, the organization shall consider the issues referre
requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed t
a) give assurance that the quality management system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunit
source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decisi
NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new
new customers, building partnerships, using new technology and other desirable and viable possibiliti
organization’s or its customers’ needs.
The organization shall determine:
The organization shall evaluate the performance and the effectiveness of the quality management sys
The organization shall retain appropriate documented information as evidence of the results.
The organization shall analyse and evaluate appropriate data and information arising from monitoring
Trends in quality and operational performance shall be compared with progress toward objectives and
support prioritization of actions for improving customer satisfaction.
The organization shall monitor, measure, analyse and evaluate its environmental performance. The or
determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid
c) the criteria against which the organization will evaluate its environmental performance, and appro
d) when the monitoring and measuring shall be performed;
e) when the results from monitoring and measurement shall be analysed and evaluated.
The organization shall ensure that calibrated or verified monitoring and measurement equipment is u
appropriate.
The organization shall evaluate its environmental performance and the effectiveness of the environm
system.
The organization shall communicate relevant environmental performance information both internally
identified in its communication process(es) and as required by its compliance obligations.
The organization shall retain appropriate documented information as evidence of the monitoring, mea
evaluation results.
rd Retention
The organization’s quality management system shall include:
NOTE The extent of documented information for a quality management system can differ from one
organization to another due to:
— the size of organization and its type of activities, processes, products and services;
— the complexity of processes and their interactions;
— the competence of persons.
When creating and updating documented information, the organization shall ensure appropriate:
7.5.3.2 For the control of documented information, the organization shall address the following activit
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
Documented information of external origin determined by the organization to be necessary for the pla
the quality management system shall be identified as appropriate, and be controlled.
Documented information retained as evidence of conformity shall be protected from unintended alter
NOTE Access can imply a decision regarding the permission to view the documented information only
authority to view and change the documented information.
The organization shall define, document, and implement a record retention policy. The control of reco
statutory, regulatory, organizational, and customer requirements.
Production part approvals, tooling records (including maintenance and ownership), product and proce
purchase orders (if applicable), or contracts and amendments shall be retained for the length of time
for production and service requirements, plus one calendar year, unless otherwise specified by the cu
agency.
NOTE Production part approval documented information may include approved product, applicable te
approved test data.
The organization’s environmental management system shall include:
a) documented information required by this International Standard;
b) documented information determined by the organization as being necessary for the effectiveness
management system.
NOTE The extent of documented information for an environmental management system can differ fr
another due to:
— the size of organization and its type of activities, processes, products and services;
— the need to demonstrate fulfilment of its compliance obligations;
— the complexity of processes and their interactions;
— the competence of persons doing work under the organization’s control.
When creating and updating documented information, the organization shall ensure appropriate:
a) identification and description {e.g. a title, date, author, or reference number);
b) format {e.g. language, software version, graphics) and media {e.g. paper, electronic);
c) review and approval for suitability and adequacy.
Documented information required by the environmental management system and by this Internationa
controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected {e.g. from loss of confidentiality, improper use, or loss of integrity).
For the control of documented information, the organization shall address the following activities as a
— distribution, access, retrieval and use;
— _ storage and preservation, including preservation of legibility;
— control of changes (e.g. version control);
— retention and disposition.
Documented information of external origin determined by the organization to be necessary for the pla
the environmental management system shall be identified, as appropriate, and controlled
NOTE Access can imply a decision regarding the permission to view the documented information only
permission and authority to view and change the documented information.
a) determine the necessary competence of person(s) doing work under its control that affects the per
effectiveness of the quality management system;
b) ensure that these persons are competent on the basis of appropriate education, training, or experie
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectivenes
d) retain appropriate documented information as evidence of competence.
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the
of currently employed persons; or the hiring or contracting of competent persons.
The organization shall establish and maintain a documented process(es) for identifying training needs
(see Section 7.3.1) and achieving competence of all personnel performing activities affecting conform
process requirements. Personnel performing specific assigned tasks shall be qualified, as required, wi
the satisfaction of customer requirements. To reduce or eliminate risks to the organization, the trainin
also include information about prevention relevant for the organization’s working environments and e
responsibilities, such as recognizing the symptoms of pending equipment failure and/or attempted cy
The organization shall provide on-the-job training (which shall include customer requirements training
new or modified responsibilities affecting conformity to quality requirements, internal requirements, r
requirements; this shall include contract or agency personnel.
The level of detail required for on-the-job training shall be commensurate with the level of education t
and the complexity of the task(s) they are required to perform for their daily work. Persons whose wor
be informed about the consequences of nonconformity to customer requirements.
The organization shall ensure that persons doing work under the organization’s control are aware of:
a) the environmental policy;
b) the significant environmental aspects and related actual or potential environmental impacts assoc
c) their contribution to the effectiveness of the environmental management system, including the be
environmental performance;
d) the implications of not conforming with the environmental management system requirements, inc
organization’s compliance obligations.
The organization shall determine and select opportunities for improvement and implement any neces
customer requirements and enhance customer satisfaction.
NOTE Examples of improvement can include correction, corrective action, continual improvement,
breakthrough change, innovation and re-organization.
The organization shall continually improve the suitability, adequacy and effectiveness of the quality.
The organization shall consider the results of analysis and evaluation, and the outputs from
management review, to determine if there are needs or opportunities that shall be addressed as part
continual improvement.
The organization shall determine opportunities for improvement (see 9.1, 9.2 and 9.3) and implement
achieve the intended outcomes of its environmental management system.
The organization shall continually improve the suitability, adequacy and effectiveness of the environm
system to enhance environmental performance.
e actions
10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable:
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does no
recur or occur elsewhere, by:
The organization shall establish a process to lessen the impact of negative effects of risk including the
When the organization determines the need for changes to the quality management system, the chan
in a planned manner (see 4.4).
The organization shall maintain its premises in a state of order, cleanliness, and repair that is consiste
manufacturing process needs.
K05 Policy
K07 Objectives
K16 Code of conduct
QP 1.5-4 5S
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8.2.3.1.3 Organization
IATF 16949
manufacturing feasibility
8.3.3.3 Special
IATF 16949
characteristics
8.3.5.2 Manufacturing
IATF 16949
process design output
Borg Warner
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When determining the requirements for the products and services to be offered to customers, the
organization shall ensure that:
a) the requirements for the products and services are defined, including:
1) any applicable statutory and regulatory requirements;
2) those considered necessary by the organization;
b) the organization can meet the claims for the products and services it offers.
These requirements shall include recycling, environmental impact, and characteristics identified as a
organization's knowledge of the product and manufacturing processes. Compliance to ISO 9001, Secti
include but not be limited to the following: all applicable government, safety, and environmental regu
acquisition, storage, handling, recycling, elimination, or disposal of material.
8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and
customers. The organization shall conduct a review before committing to supply products and service
include:
a) requirements specified by the customer, including the requirements for delivery and post delivery a
b) requirements not stated by the customer, but necessary for the specified or intended use, when kn
c) requirements specified by the organization;
d) statutory and regulatory requirements applicable to the products and services;
e) contract or order requirements differing from those previously expressed
The organization shall ensure that contract or order requirements differing from those previously
defined are resolved.
The customer’s requirements shall be confirmed by the organization before acceptance, when the
customer does not provide a documented statement of their requirements.
NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead
review can cover relevant product information, such as catalogues.
The organization shall retain documented evidence of a customer-authorized waiver for the requireme
Section 8.2.3.1, for a formal review.
The organization shall conform to customer requirements for designation, approval documentation, an
control of special characteristics.
The requirements of ISO 9001, Section 8.3.1, shall apply to product and manufacturing process design
shall focus on error prevention rather than detection. The organization shall document the design an
In determining the stages and controls for design and development, the organization shall consider:
a) the nature, duration and complexity of the design and development activities;
b) the required process stages, including applicable design and development reviews;
c) the required design and development verification and validation activities;
d) the responsibilities and authorities involved in the design and development process;
e) the internal and external resource needs for the design and development of products and services
f) the need to control interfaces between persons involved in the design and development process;
g) the need for involvement of customers and users in the design and development process;
h) the requirements for subsequent provision of products and services;
i) the level of control expected for the design and development process by customers and other rele
j) the documented information needed to demonstrate that design and development requirement
The organization shall ensure that design and development planning includes all affected stakeholder
and, as appropriate, its supply chain. Examples of areas for using such a multidisciplinary approach in
to the following:
a) project management (for example, APQP or VDA-RGA);
b) product and manufacturing process design activities (for example, DFM and DFA), such as consider
alternative designs and manufacturing processes;
c) development and review of product design risk analysis (FMEAs), including actions to reduce poten
d) development and review of manufacturing process risk analysis (for example, FMEAs, process flows
standard work instructions).
NOTE A multidisciplinary approach typically includes the organization’s design, manufacturing, engin
production, purchasing, supplier, maintenance, and other appropriate functions.
The organization shall determine the requirements essential for the specific types of products and ser
developed. The organization shall consider:
a) functional and performance requirements;
b) information derived from previous similar design and development activities;
c) statutory and regulatory requirements;
d) standards or codes of practice that the organization has committed to implement;
e) potential consequences of failure due to the nature of the products and services.
Inputs shall be adequate for design and development purposes, complete and unambiguous.
Conflicting design and development inputs shall be resolved.
The organization shall retain documented information on design and development inputs.
The organization shall identify, document, and review manufacturing process design input requiremen
limited to the following:
a) product design output data including special characteristics;
b) targets for productivity, process capability, timing, and cost;
c) manufacturing technology alternatives;
d) customer requirements, if any;
e) experience from previous developments;
f) new materials;
g) product handling and ergonomic requirements; and
h) design for manufacturing and design for assembly.
The manufacturing process design shall include the use of error-proofing methods to a degree approp
the problem(s) and commensurate with the risks encountered.
The organization shall use a multidisciplinary approach to establish, document, and implement its pro
special characteristics, including those determined by the customer and the risk analysis performed b
shall include the following:
a) documentation of all special characteristics in the drawings (as required), risk analysis (such as FME
standard work/operator instructions; special characteristics are identified with specific markings and a
each of these documents;
b) development of control and monitoring strategies for special characteristics of products and produc
c) customer-specified approvals, when required;
d) compliance with customer-specified definitions and symbols or the organization’s equivalent symbo
defined in a symbol conversion table. The symbol conversion table shall be submitted to the custome
The organization shall apply controls to the design and development process to ensure that:
a) the results to be achieved are defined;
b) reviews are conducted to evaluate the ability of the results of design and development to meet req
c) verification activities are conducted to ensure that the design and development outputs meet the in
d) validation activities are conducted to ensure that the resulting products and services meet the requ
specified application or intended use;
e) any necessary actions are taken on problems determined during the reviews, or verification and va
f) documented information of these activities is retained.
NOTE Design and development reviews, verification and validation have distinct purposes. They can b
or in any combination, as is suitable for the products and services of the organization.
Measurements at specified stages during the design and development of products and processes shal
and reported with summary results as an input to management review (see Section 9.3.2.1).
When required by the customer, measurements of the product and process development activity shal
customer at stages specified, or agreed to, by the customer.
NOTE When appropriate, these measurements may include quality risks, costs, lead times, critical pat
measurements.
Design and development validation shall be performed in accordance with customer requirements, in
industry and governmental agency-issued regulatory standards. The timing of design and developmen
planned in alignment with customer-specified timing, as applicable.
Where contractually agreed with the customer, this shall include evaluation of the interaction of the o
including embedded software, within the system of the final customer’s product.
When required by the customer, the organization shall have a prototype programme and control plan
use, whenever possible, the same suppliers, tooling, and manufacturing processes as will be used in p
performance-testing activities shall be monitored for timely completion and conformity to requiremen
outsourced, the organization shall include the type and extent of control in the scope of its quality ma
ensure that outsourced services conform to requirements (see ISO 9001, Section 8.4).
The organization shall establish, implement, and maintain a product and manufacturing approval proc
requirements defined by the customer(s).
The organization shall approve externally provided products and services per ISO 9001, Section 8.4.3,
their part approval to the customer.
The organization shall obtain documented product approval prior to shipment, if required by the cus
Records of such approval shall be retained.
NOTE Product approval should be subsequent to the verification of the manufacturing process.
The organization shall document the manufacturing process design output in a manner that enables v
manufacturing process design inputs. The organization shall verify the outputs against manufacturing
requirements. The manufacturing process design output shall include but is not limited to the followin
a) specifications and drawings;
b) special characteristics for product and manufacturing process;
c) identification of process input variables that impact characteristics;
d) tooling and equipment for production and control, including capability studies of equipment and pr
e) manufacturing process flow charts/layout, including linkage of product, process, and tooling;
f) capacity analysis;
g) manufacturing process FMEA;
h) maintenance plans and instructions;
i) control plan (see Annex A);
j) standard work and work instructions;
k) process approval acceptance criteria;
l) data for quality, reliability, maintainability, and measurability;
m) results of error-proofing identification and verification, as appropriate;
n) methods of rapid detection, feedback, and correction of product/manufacturing process nonconform
The organization shall identify, review and control changes made during, or subsequent to, the design
products and services, to the extent necessary to ensure that there is no adverse impact on conformit
The organization shall retain documented information on:
a) design and development changes;
b) the results of reviews;
c) the authorization of the changes;
d) the actions taken to prevent adverse impacts.
The organization shall evaluate all design changes after initial product approval, including those propo
or its suppliers, for potential impact on fit, form, function, performance, and/or durability. These chang
against customer requirements and approved internally, prior to production implementation. If requir
organization shall obtain documented approval, or a documented waiver, from the customer prior t
implementation.
GSM-F023 Feasibility Commitment Form
General
BorgWarner requires all Suppliers to take ownership of and manage the APQP process. A BorgWarner
initiate the quality planning process with Suppliers during the APQP Kick-Off meeting. Suppliers subse
obligation to establish a cross-functional team to manage the Product Quality Planning process utilizi
Electronic eAPQP system. BorgWarner will provide Suppliers with the prototype/pre-production, PP
requirements and dates, as noted in the due dates of the eAPQP system or form. Suppliers will be resp
their product quality planning timelines up to date in this system. Suppliers are expected to update th
completion dates in the system on frequent intervals or when there is a change that will impact overa
Additional details are available in a separate Supplier eAPQP guide, available on BorgWarner’s Supplie
https://extraice.borgwarner.com/Suppliers.
12.2.
Approval of Packaging
• Suppliers must utilize Supplier Packaging Form (GSM-F012) unless otherwise directed as part o
• All Packaging material must comply with ISPM 15 or any of its future revisions.
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The organization shall define and implement the necessary actions to ensure product compliance with
planned or unplanned production shutdown period.
The organization shall immediately notify the customer(s) in the event that nonconforming product ha
communication shall be followed with detailed documentation of the event.
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9.1.1.3 Application of
IATF 16949
statistical concepts
Description
Statistical studies shall be conducted to analyse the variation present in the results of each type of ins
and test equipment system identified in the control plan. The analytical methods and acceptance crite
to those in reference manuals on measurement systems analysis. Other analytical methods and accep
used if approved by the customer. Records of customer acceptance of alternative methods shall be re
from alternative measurement systems analysis (see Section 9.1.1.1).
NOTE Prioritization of MSA studies should focus on critical or special product or process characteristic
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standard
international or national measurement standards; when no such standards exist, the basis used for ca
shall be retained as documented information;
b) identified in order to determine their status;
c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status
measurement results.
The organization shall determine if the validity of previous measurement results has been adversely a
equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessar
NOTE A number or another identifier traceable to the device calibration record meets the intent of the
9001:2015.
Statistical concepts, such as variation, control (stability), process capability, and the consequences of
be understood and used by employees involved in the collection, analysis, and management of statist
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9.1.1.2 Identification of
IATF 16949
statistical tools
The organization shall determine the appropriate use of statistical tools. The organization shall verify
included as part of the advanced product quality planning (or equivalent) process and included in the
DFMEA) (where applicable), the process risk analysis (such as PFMEA), and the control plan.
The organization shall develop control plans (in accordance with Annex A) at the system, subsystem,
for the relevant manufacturing site and all product supplied, including those for processes producing b
Family control plans are acceptable for bulk material and similar parts using a common manufacturing
The organization shall have a control plan for pre-launch and production that shows linkage and incor
risk analysis (if provided by the customer), process flow diagram, and manufacturing process risk ana
organization shall, if required by the customer, provide measurement and conformity data collected d
launch or production control plans.
The organization shall review control plans, and update as required, for any of the following:
If required by the customer, the organization shall obtain customer approval after review or revision o
9.6 Early Production Containment (EPC)
General
Unless otherwise directed, this requirement applies to all Suppliers to BorgWarner. It is to be used for all pre-production and production req
Approval Process, and whenever mandated by BorgWarner on any parts that present significant risk to a BorgWarner plant. e.g., at annual s
Definition and Purpose
The purpose of EPC is:
To reduce the risk to BorgWarner and to protect the Supplier through increased detection
• To document Supplier efforts to gain control of its processes during start-up and launch so that any quality issues that may arise are quick
location and not at the Customer’s manufacturing location
• To increase involvement and visibility of the Supplier’s top management.
EPC requires a documented launch or pre-launch control plan that is a significant enhancement to the Supplier’s production control plan. Th
ensure that all products shipped will meet BorgWarner expectations. This is an extraordinary launch measure. The EPC Plan will also serve t
Plan should take into consideration all known critical conditions of the part as well as potential areas of concern identified during the Produc
the Pre-Launch Control Plan referred to in section 3.7 of the Chrysler, Ford, & GM Advanced Product Quality Planning and Control Plan Refere
During the APQP Kick-Off Meeting, a completed EPC Commitment Form (GSM- F018) will be signed by the Supplier.
Supplier Responsibility
Establish a containment process that has the following elements:
• Identification of the person responsible for the containment process • Development of an EPC Plan consisting of additional controls, inspe
process (set-up, machinery, fixture, tooling, operator, material/components, preventive maintenance, climate). Additional controls could inc
o Off-line, separate and independent check from the normal production process o Increased frequency/sample size of receiving, process, a
Supplier containment and/or sub-Supplier support/audits as required o Increased verification of label accuracy o Increased error proofing v
by top management, including increased Management Internal Audits o Other items as specified by BorgWarner or the Supplier o Prompt i
action if nonconformances are discovered.
•Document the EPC Plan (including functional testing and error proofing, if applicable) using the Control Plan format referenced in the Advan
Reference Manual, respectively, as mentioned in IATF 16949 appendix A. The development and documentation of the EPC Plan is expected
Planning Process. The EPC Plan is not a substitute for the Production Control Plan but is over and above the Production Control Plan and is us
• To indicate compliance with the EPC requirements, Suppliers will attach to each shipment label a special marking as agreed to between th
BorgWarner Responsibility
• The EPC quantity/timeframe will be agreed to with the Supplier and based on BorgWarner’s Customer requirement. • Review and approv
Supplier.
Exit Criteria
Supplier will be eligible to Self-Exit Early Production Containment provided it meets the quantity/timeframe agreed to with no discrepancies
event the self-exit criteria has been met but the EPC plan continues to identify non-conformances, the EPC plan must be kept in place until p
effective, and the Production Control Plan is validated to BorgWarner’s satisfaction.
Consequences of Shipping Non-Conforming Material
• Failure to execute EPC may result in Controlled Shipping. • Shipment of discrepant material during the specified EPC period or any other
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QP 4.1-2 Process Flow, PFMEA and Control Plan
Special form GSM-F018 available in Visma
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The organization shall have a documented process to determine the use of appropriate error-proofi
Details of the method used shall be documented in the process risk analysis (such as PFMEA) and test
documented in the control plan. The process shall include the testing of error-proofing devices for fail
Records shall be maintained. Challenge parts, when used, shall be identified, controlled, verified, and
feasible. Error-proofing device failures shall have a reaction plan.
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The organization shall plan, implement and control the processes (see 4.4) needed to meet the requir
of products and services, and to implement the actions determined in Clause 6, by:
1) the processes;
2) the acceptance of products and services;
c) determining the resources needed to achieve conformity to the product and service requirements;
d) implementing control of the processes in accordance with the criteria;
e) determining, maintaining and retaining documented information to the extent necessary:
1) to have confidence that the processes have been carried out as planned;
2) to demonstrate the conformity of products and services to their requirements.
The output of this planning shall be suitable for the organization’s operations.
The organization shall control planned changes and review the consequences of unintended changes,
taking action to mitigate any adverse effects, as necessary.
When planning for product realization, the following topics shall be included:
The resources identified in ISO 9001, Section 8.1 c), refer to the required verification, validation, moni
inspection, and test activities specific to the product and the criteria for product acceptance.
The organization shall implement production and service provision under controlled conditions.
1) the characteristics of the products to be produced, the services to be provided, or the activities to b
2) the results to be achieved;
NOTE Suitable infrastructure includes appropriate manufacturing equipment required to ensure produ
Monitoring and measuring resources include appropriate monitoring and measuring equipment requir
control of manufacturing processes.
The organization shall:
a) verify job set-ups when performed, such as an initial run of a job, material changeover, or job chan
set-up;
b) maintain documented information for set-up personnel;
c) use statistical methods of verification, where applicable;
d) perform first-off/last-off part validation, as applicable; where appropriate, first-off parts should be re
with the last-off parts; where appropriate, last-off-parts should be
retained for comparison with first-off parts in subsequent runs;
e) retain records of process and product approval following set-up and first-off/last-off part
validations.
The organization shall perform process studies on all new manufacturing (including assembly or seque
verify process capability and to provide additional input for process control, including those for specia
NOTE For some manufacturing processes, it may not be possible to demonstrate product compliance
capability. For those processes, alternate methods such as batch conformance to specification may be
The organization shall maintain manufacturing process capability or performance results as specified
approval process requirements. The organization shall verify that the process flow diagram, PFMEA, a
implemented, including adherence to the following:
a) measurement techniques;
b) sampling plans;
c) acceptance criteria;
d) records of actual measurement values and/or test results for variable data;
e) reaction plans and escalation process when acceptance criteria are not met.
Significant process events, such as tool change or machine repair, shall be recorded and retained as d
information.
The organization shall initiate a reaction plan indicated on the control plan and evaluated for impact o
specifications for characteristics that are either not statistically capable or are unstable. These reactio
containment of product and 100 percent inspection, as appropriate. A corrective action plan shall be d
implemented by the organization indicating specific actions, timing, and assigned responsibilities to e
becomes stable and statistically capable. The plans shall be reviewed with and approved by the custo
organization shall maintain records of effective dates of process changes.
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The organization shall implement planned arrangements, at appropriate stages, to verify that the pro
requirements have been met.
The release of products and services to the customer shall not proceed until the planned arrangemen
have been satisfactorily completed, unless otherwise approved by a relevant authority and, as
applicable, by the customer.
The organization shall retain documented information on the release of products and services. The
documented information shall include:
The organization shall ensure that the planned arrangements to verify that the product and service re
met encompass the control plan and are documented as specified in the control plan (see Annex A). T
ensure that the planned arrangements for initial release of products and services encompass product
organization shall ensure that product or service approval is accomplished after changes following init
ISO 9001, Section 8.5.6.
A layout inspection and a functional verification to applicable customer engineering material and perf
be performed for each product as specified in the control plans. Results shall be available for custome
NOTE 1 Layout inspection is the complete measurement of all product dimensions shown on the desig
NOTE 2 The frequency of layout inspection is determined by the customer.
For organizations manufacturing parts designated by the customer as “appearance items,” the organi
following:
a) appropriate resources, including lighting, for evaluation;
b) masters for colour, grain, gloss, metallic brilliance, texture, distinctness of image (DOI), and haptic
appropriate;
c) maintenance and control of appearance masters and evaluation equipment;
d) verification that personnel making appearance evaluations are competent and qualified to do so.
The organization shall have a process to ensure the quality of externally provided processes, products
one or more of the following methods:
a) receipt and evaluation of statistical data provided by the supplier to the organization;
b) receiving inspection and/or testing, such as sampling based on performance;
c) second-party or third-party assessments or audits of supplier sites when coupled with records of ac
product conformance to requirements;
d) part evaluation by a designated laboratory;
e) another method agreed with the customer.
Prior to release of externally provided products into its production flow, the organization shall confirm
evidence that externally provided processes, products, and services conform to the latest applicable s
other requirements in the countries where they are manufactured and in the customer-identified coun
provided
Acceptance criteria shall be defined by the organization and, where appropriate or required, approved
attribute data sampling, the acceptance level shall be zero defects (see Section 9.1.1.1).
9.5 Production Part Approval Process (PPAP)
General
Suppliers must comply with the latest edition of the AIAG Production Part Approval Process reference manual, VDA Standard
and with all requirements outlined in this Supplier Manual. In addition, certain Customer specific requirements could
apply. PPAP Submission Requirements Unless specifically waived in writing by BorgWarner, all Supplier PPAP submissions m
Supplier PPAP Check Sheet (GSM-F005 or Business Unit specific requirements), which validates that all PPAP docum
Prior to a Supplier submitting a PPAP to BorgWarner, all of their sub-Supplier PPAP’s must have been approved by the Suppli
in writing by BorgWarner, the Supplier must complete and submit the sub-Supplier Matrix (GSM-F027) along with the PP
tion
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8.5.1.7 Production
IATF 16949
scheduling
Description
The organization shall ensure that production is scheduled in order to meet customer orders/ demand
(JIT) and is supported by an information system that permits access to production information at key s
is order driven.
The organization shall include relevant planning information during production scheduling, e.g., custo
time delivery performance, capacity, shared loading (multi-part station), lead time, inventory level, pr
and calibration.
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10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable:
b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does no
recur or occur elsewhere, by:
The organization shall establish a process to lessen the impact of negative effects of risk including the
tion
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8.7.1.1 Customer
IATF 16949 authorization for concession 9 SIS
8.7.1.2 Control of
IATF 16949 nonconforming product -
customer-specified process
8.7.1.7 Nonconforming
IATF 16949 11 FAQ
product disposition
Valmet
8.7.1 The organization shall ensure that outputs that do not conform to their requirements are identifi
prevent their unintended use or delivery.
The organization shall take appropriate action based on the nature of the nonconformity and its effect
products and services. This shall also apply to nonconforming products and services detected after de
during or after the provision of services.
The organization shall deal with nonconforming outputs in one or more of the following ways:
a) correction;
b) segregation, containment, return or suspension of provision of products and services;
c) informing the customer;
d) obtaining authorization for acceptance under concession.
Conformity to the requirements shall be verified when nonconforming outputs are corrected.
The organization shall obtain a customer concession or deviation permit prior to further processing wh
manufacturing process is different from that which is currently approved.
The organization shall obtain customer authorization prior to further processing for “use as is” and for
product. If sub-components are reused in the manufacturing process, that sub-component reuse shal
communicated to the customer in the concession or deviation permit.
The organization shall maintain a record of the expiration date or quantity authorized under concessio
also ensure compliance with the original or superseding specifications and requirements when the au
Material shipped under concession shall be properly identified on each shipping container (this applie
product). The organization shall approve any requests from suppliers before submission to the custom
The organization shall comply with applicable customer-specified controls for nonconforming product(
The organization shall ensure that product with unidentified or suspect status is classified and control
product. The organization shall ensure that all appropriate manufacturing personnel receive training f
suspect and nonconforming product.
The organization shall utilize risk analysis (such as FMEA) methodology to assess risks in the rework p
to rework the product. If required by the customer, the organization shall obtain approval from the cu
commencing rework of the product.
The organization shall have a documented process for rework confirmation in accordance with the
relevant documented information to verify compliance to original specifications.
Instructions for disassembly or rework, including re-inspection and traceability requirements, shall be
utilized by the appropriate personnel.
The organization shall retain documented information on the disposition of reworked product includin
disposition date, and applicable traceability information.
The organization shall utilize risk analysis (such as FMEA) methodology to assess risks in the repair p
to repair the product. The organization shall obtain approval from the customer before commencing r
The organization shall have a documented process for repair confirmation in accordance with the cont
relevant documented information.
Instructions for disassembly or repair, including re-inspection and traceability requirements, shall be a
by the appropriate personnel.
The organization shall obtain a documented customer authorization for concession for the product to
The organization shall retain documented information on the disposition of repaired product including
disposition date, and applicable traceability information.
The organization shall immediately notify the customer(s) in the event that nonconforming product ha
communication shall be followed with detailed documentation of the event.
The organization shall have a documented process for disposition of nonconforming product not subje
For product not meeting requirements, the organization shall verify that the product to be scrapped is
to disposal. The organization shall not divert nonconforming product to service or other use without p
tion
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The organization shall perform analysis on customer complaints and field failures, including any re
initiate problem solving and corrective action to prevent recurrence. Where requested by the custo
analysis of the interaction of embedded software of the organization's product within the system o
product.
The organization shall communicate the results of testing/analysis to the customer and also within
9.8.4 Controlled Shipping
Controlled Shipping
• BorgWarner may determine that special measures are required to ensure adequate quality and delivery performance. The costs relat
not limited to Controlled Shipping, will be at the Supplier’s expense.
• Controlled Shipping is a requirement by BorgWarner for a Supplier to add a redundant inspection process for sorting of a specific non
root cause problem-solving process. The redundant inspection is in addition to normal controls and should be completed in a controlled
Assessment Form – I-Chart (GSM-F009) showing inspection results is required. The data obtained from the redundant inspection pr
the effectiveness of the secondary inspection process and the corrective actions taken to eliminate the initial nonconformance.
• BorgWarner will notify the Supplier they have been placed on Controlled Shipping.
Two levels of Controlled Shipping exist:
o Level 1 includes a problem-solving process as well as a redundant inspection process. The Supplier’s employees at the Supplier’s loca
order to isolate the Customer from receipt of non- conforming parts/material.
o Level 2 includes the same processes as Controlled Shipping – Level 1, with an added inspection process by a third-party representing
Customer’s interests specific to the containment activity. The third party is selected by the Supplier, approved by BorgWarner or BorgW
Supplier. Suppliers may select the third party from an approved listing maintained by BorgWarner or BorgWarner’s Customer.
• Other measures may be required if Level 2 controls are not effective. Criteria for application for Controlled Shipping – Level 1 or 2:
o BorgWarner will make the determination whether the Supplier can effectively correct the non-conforming material situation through t
process and isolate BorgWarner or BorgWarner’s Customer from the problem. One or several of the following issues may be cause for S
implementation of Controlled Shipping:
▪ Repeat CPMs ▪ Supplier’s current controls are not sufficient to ensure conformance to requirements ▪ Duration, quantity, and/or sev
Internal/external Supplier data ▪ Controlled Shipping – Level 1 failures ▪ Major disruptions ▪ Quality problem in the field (i.e., warranty
o Based on consideration of the above, BorgWarner decides whether Level 1 or Level 2 would be appropriate.
o A 3rd party or a BorgWarner representative may perform audits. The data obtained from the 3rd party redundant inspection process
both a measure of the effectiveness of the secondary inspection process and the corrective actions taken to eliminate the initial non-
conformance.
o In special cases, the Controlled Shipping – Level 2 inspection may be required to be performed outside the Supplier’s facilities at a fac
BorgWarner.
• Exit criteria Controlled Shipping – Level 1 & Controlled Shipping – Level 2:
o The default exit criteria will be used when no other exit criteria are defined. The default criteria are listed below and must be provided
representative when requesting removal from Controlled Shipping:
▪ Twenty (20) working days of data from the containment activity, and a summary, which verifies that normal production controls are e
controlling the discrepancy(ies) identified in the Controlled Shipping activity. The time begins accumulating from the date of implementa
▪ Documentation showing the root cause was identified and verified ▪ Documentation indicating that corrective action was implement
validated ▪ Documentation indicating that every effort was taken to implement error
proofing ▪ Copies of all documentation revised as required (control plan, FMEAs,
process flow diagram, operator’s instructions, training records, etc.) ▪ Statistical data where appropriate ▪ Other information requested
o Additional exit criteria for CS2 Only:
▪ Copy of Passing CS2 Assessment Form (GSM-F009) and completed action plans ▪ 3rd Party Registrar’s statement of approval (or plan
undertaken by Supplier related to the controlled shipping issue(s) if requested by BorgWarner or BorgWarner’s Customer.
9.8.3 8-D Reports
• General
- The Supplier will respond to CPMs by using the BorgWarner 8-D Problem Solving Form (GSM-F007) or other form approved
personnel. The 8-D documentation will be submitted in response to each CPM, unless otherwise agreed to by the appropriate BorgW
preferred method of response.
• Initial Submission
- BorgWarner must receive the initial 8-D response within 24 hours of notification. The 3-D report, with the contain
results found, must be submitted within 48 hours and the 5-D report must be submitted within 14 days. The 5-D report mu
implementation of the long term corrective action items. The above deadlines apply, unless otherwise specified (e.g. if a cust
as 5-D closure within 7 days instead of 14 days, BorgWarner may require a faster response from the Supplier).
• Final Submission
- Suppliers must submit the final 8-D Problem Solving Form for approval and closure as soon as practical, but no later than 30 da
Supplier may request approval for an extension of the 30- day deadline, but must do so prior to the original deadline. Requests should
representative of BorgWarner.
• Approval and Closure
- The appropriate BorgWarner representative prior to closure of a CPM must approve a Supplier’s final 8-D Report. Any 8-Ds open bey
the Supplier’s performance rating (see Supplier Performance Metrics section).
'- If the 8-D identifies a change to the process or part, the BorgWarner Change Management requirements MUST be followed (see Su
• Supplier may be requested to present their corrective actions on-site at the BorgWarner Facility.
• BorgWarner and its Customers reserve the right to verify product conformance to the requirements at the Supplier’s and their subcon
• Verification of the implemented corrective action on-site at the Supplier may be accomplished during subsequent visits.
• If Corrective Actions take more than two (2) weeks to implement, a progress report may be required.
• When the corrective action is completed and verified to be effective, the
BorgWarner 8-D Champion is responsible for approving the 8-D closure and notifying the Supplier contact of the closure.
PC 9-3.1 Complaint
Special form GSM-F009 available in Visma
PC 9-3.1 Complaint
Special form GSM-F007 availabe in Visma
PC 9-3.1 Complaint
PC 9-3.1 Complaint
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ISO 9001
6.3 Planning of changes
ISO 9001
8.5.6 Control of changes x
When the organization determines the need for changes to the quality management system, the chan
in a planned manner (see 4.4).
The organization shall review and control changes for production or service provision, to the extent ne
continuing conformity with requirements.
The organization shall retain documented information describing the results of the review of chang
authorizing the change, and any necessary actions arising from the review.
The organization shall have a documented process to control and react to changes that impact prod
effects of any change, including those changes caused by the organization, the customer, or any supp
The organization shall
a) define verification and validation activities to ensure compliance with customer requirements;
b) validate changes before implementation
c) document the evidence of related risk analysis
d) retain records of verification and validation.
Changes, including those made at suppliers, should require a production trial run for verification of ch
to part design, manufacturing location, or manufacturing process) to validate the impact of any chang
process.
tion
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5 SIS
7.5.1.1 Quality management 8 FAQ
IATF 16949 x
system documentation
ISO 9001
7.5.2 Creating and updating
7.5.3 Control of documented
ISO 9001
information
7.5.3.1 / 7.5.3.2
7.5.3.2.2 Engineering
IATF 16949 specifications x
8.5.1.2 Standardised work -
IATF 16949 operator instructions and
visual standards
7.5 Documented
ISO 14001
information x
7.5.1 General
ISO 14001
7.5.2 Creating and updating
Borg Warner
NOTE The extent of documented information for a quality management system can differ from one
organization to another due to:
— the size of organization and its type of activities, processes, products and services;
— the complexity of processes and their interactions;
— the competence of persons.
The organization's quality management system shall be documented and include a quality manual,
documents (electronic or hard copy).
The format and structure of the quality manual is at the discretion of the organization and will depend
size, culture, and complexity. If a series of documents is used, then a list shall be retained of the docu
quality manual for the organization. The quality manual shall include, at a minimum, the following:
a) the scope of the quality management system, including details of and justification for any exclusion
b) documented processes established for the quality management system, or reference to them;
c) the organization's processes and their sequence and interactions (inputs and outputs), including ty
of any outsourced processes;
d) a document (for example, a table, a list, or a matrix) indicating where within the organization's qua
their customer-specific requirements are addressed.
NOTE A matrix of how the requirements of this Automotive QMS standard are addressed by the organ
be used to assist with linkages of the organization's processes and this Automotive QMS
When creating and updating documented information, the organization shall ensure appropriate:
7.5.3.2 For the control of documented information, the organization shall address the following activit
a) distribution, access, retrieval and use;
b) storage and preservation, including preservation of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
Documented information of external origin determined by the organization to be necessary for the pla
the quality management system shall be identified as appropriate, and be controlled.
Documented information retained as evidence of conformity shall be protected from unintended alter
NOTE Access can imply a decision regarding the permission to view the documented information only
authority to view and change the documented information.
The organization shall define, document, and implement a record retention policy. The control of rec
statutory, regulatory, organizational, and customer requirements.
Production part approvals, tooling records (including maintenance and ownership), product and proce
purchase orders (if applicable), or contracts and amendments shall be retained for the length of time
for production and service requirements, plus one calendar year, unless otherwise specified by the cu
agency.
NOTE Production part approval documented information may include approved product, applicable te
approved test data.
The organization shall have a documented process describing the review, distribution, and impleme
engineering standards/specifications and related revisions based on customer schedules, as required.
When an engineering standard/specification change results in a product design change, refer to the re
Section 8.3.6. When an engineering standard/specification change results in a product realization proc
requirements in Section 8.5.6.1. The organization shall retain a record of the date on which each chan
production. Implementation shall include updated documents.
Review should be completed within 10 working days of receipt of notification of engineering standard
changes.
NOTE A change in these standards/specifications may require an updated record of customer product
these specifications are referenced on the design record or if they affect documents of the production
such as control plan, risk analysis (such as FMEAs), etc.
The organization shall ensure that standardised work documents are:
a) communicated to and understood by the employees who are responsible for performing the work;
b) legible;
C) presented in the language(s) understood by the personnel responsible to follow them;
d) accessible for use at the designated work area(s).
The standardised work documents shall also include rules for operator safety.
When creating and updating documented information, the organization shall ensure appropriate:
a) identification and description {e.g. a title, date, author, or reference number);
b) format {e.g. language, software version, graphics) and media {e.g. paper, electronic);
c) review and approval for suitability and adequacy.
Documented information required by the environmental management system and by this Internationa
controlled to ensure:
a) it is available and suitable for use, where and when it is needed;
b) it is adequately protected {e.g. from loss of confidentiality, improper use, or loss of integrity).
For the control of documented information, the organization shall address the following activities as a
— distribution, access, retrieval and use;
— _ storage and preservation, including preservation of legibility;
— control of changes (e.g. version control);
— retention and disposition.
Documented information of external origin determined by the organization to be necessary for the pla
the environmental management system shall be identified, as appropriate, and controlled
NOTE Access can imply a decision regarding the permission to view the documented information only
permission and authority to view and change the documented information.
17 Record Retention
The control of records will satisfy all regulatory, BorgWarner, and Customer requirements. These reco
for review by BorgWarner upon request and retained for periods of time specified by BorgWarner.
8 Documentation
The supplier shall provide sufficient documentation and keep records as evidence of the planning, dev
manufacturing meeting the specifications.
Among other documents and records the following is mandatory:
- Special characteristics according to IATF 16949:2016
- Measuring / testing results of critical features
The supplier has to archive the documentation appropriately and store it at least 15 years. Upon req
shall be submitted to Valmet Automotive.
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ISO 9001
6.3 Planning of changes
ISO 9001
8.5.6 Control of changes x
8.2.4 Changes to
ISO 9001
requirements for products x
and services
Borg Warner
Valmet
When the organization determines the need for changes to the quality management system, the chan
carried out in a planned manner (see 4.4).
The organization shall review and control changes for production or service provision, to the extent ne
ensure continuing conformity with requirements.
The organization shall retain documented information describing the results of the review of chang
person(s) authorizing the change, and any necessary actions arising from the review.
The organization shall have a documented process to control and react to changes that impact prod
The effects of any change, including those changes caused by the organization, the customer, or any
be assessed. The organization shall
a) define verification and validation activities to ensure compliance with customer requirements;
b) validate changes before implementation
c) document the evidence of related risk analysis
d) retain records of verification and validation.
Changes, including those made at suppliers, should require a production trial run for verification of ch
changes to part design, manufacturing location, or manufacturing process) to validate the impact of a
the manufacturing process.
The organization shall document the process that manages the use of alternate control methods. The
shall include in this process, based on risk analysis (such as FMEA), severity, and the internal approva
obtained prior to production implementation of the alternate control method. Before shipping product
inspected or tested using the alternate method, if required, the organization shall obtain approval from
customer(s). The organization shall maintain and periodically review a list of approved alternate proce
methods that are referenced in the control plan. Standardised work instructions shall be available for
process control method. The organization shall review the operation of alternate process controls on a
minimum, to verify implementation of standard work with the goal to return to the standard process a
control plan as soon as possible. Example methods include but are not limited to the following:
Restart verification is documented for a defined period based on severity and confirmation that all fea
error-proofing device or process are effectively reinstated. The organization shall implement traceabil
produced while any alternate process control devices or processes are being used (e.g., verification a
first piece and last piece from every shift).
The organization shall ensure that relevant documented information is amended, and that relev
persons are made aware of the changed requirements, when the requirements for products and
services are changed.
11.3 Permanent Changes
General
When seeking permission to make a permanent change to the design, performance, or processing of product supplied to Bo
must request approval as described below prior to implementation. Note that any changes to Supplier-specified product ch
under this requirement even if they are not shown on the BorgWarner drawing and/or specification.
Supplier Change Request
• Suppliers seeking permanent changes to product design, performance, or processing must complete and submit eSCR (e
Change Request) to the appropriate BorgWarner Supplier Representative for review.
o The form must include all relevant information.
o BorgWarner may approve, reject, or apply conditions of approval to the SCR (e.g., Level 3 PPAP required after change is im
disposition is determined by the nature of the change and impact on manufacturing and Customer requirements.
• Approval of the eSCR does not authorize the Supplier to ship—it is only the authorization to proceed with coordination of P
o Suppliers must NOT:
▪ Implement changes before receiving full PPAP approval.
▪ Ship until satisfying all AIAG and/or VDA Production Part Approval Process requirements.
▪ Ship prior to the implementation date established with the BorgWarner Materials Group.
▪ Implement before obtaining approval from all affected BorgWarner plants, unless otherwise agreed to with BorgWarner.
o In cases where a Supplier has implemented an unauthorized change and BorgWarner and/or its Customers have been neg
the Supplier will be responsible for compensating BorgWarner for all associated costs incurred by BorgWarner and its Custom
11.2 Temporary Changes
When seeking permission to temporarily ship product that is out of specification or product that is produced with a temporar
not reflected in the Supplier’s current Process Control Plan, the Supplier is responsible for obtaining approval prior to shippi
Such situations might include minor dimensional errors, or a processing operation outsourced while a machine is down. Note
to Supplier-specified product characteristics also fall under this requirement even if they are not shown on the BorgWarner
drawing. Suppliers must complete and submit eSCR (electronic Supplier Change Request) to the appropriate BorgWarner Su
Representative for review and approval. Note that eSCR is used for Temporary Deviation Requests and Permanent Change R
approval sections on the form).
The Supplier must obtain written permission prior to shipping product that is out of specification and carry out the following:
• Submit eSCR (electronic Supplier Change Request)
• Check box for Temporary Deviation Request only
• Track the eSCR expiration date and applicable quantity of product
• Ship product within the scope of the eSCR
• Obtain authorization for additional shipments beyond the agreed limit
• Approval must be obtained from all affected BorgWarner plants before implementing, unless otherwise agreed to with Bor
tion
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4.3.2 Customer-specific
IATF 16949
requirements
Description
Customer-specific requirements shall be evaluated and included in the scope of the organization's qua
system.
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ISO 9001
9.2 Internal audit
20 FAQ
IATF 16949 9.2.2.4 Product audit
22 FAQ
9.2.1 The organization shall conduct internal audits at planned intervals to provide information on
whether the quality management system:
a) conforms to:
1) the organization’s own requirements for its quality management system;
2) the requirements of this International Standard;
b) is effectively implemented and maintained.
The organization shall have a documented internal audit process. The process shall include the develo
implementation of an internal audit programme that covers the entire quality management system in
management system audits, manufacturing process audits, and product audits. The audit programme
based upon risk, internal and external performance trends, and criticality of the process(es). Where th
responsible for software development, the organization shall include software development capability
internal audit programme. The frequency of audits shall be reviewed and, where appropriate, adjusted
process changes, internal and external nonconformities, and/or customer complaints. The effectivene
programme shall be reviewed as a part of management review.
The organization shall audit all quality management system processes over three-year audit cycle, ac
programme, using the process approach to verify compliance with this Automotive QMS Standard. Int
audits, the organization shall sample customer specific quality management system requirements for
implementation. The complete audit cycle remains three years in length. The quality management sy
individual processes, audited within the three-year audit cycle, shall be based upon internal and exter
risk. Organizations shall maintain justification for the assigned audit frequency of their processes. All p
be sampled throughout the three-year audit cycle and audited to all applicable requirements in the IA
including ISO 9001 base requirements, and any customer-specific requirements.
The organization shall audit all manufacturing processes over each three-year calendar period to dete
and efficiency using customer-specific required approaches for process audits. Where not defined by t
organization shall determine the approach to be used. Within each individual audit plan, each manufa
audited on all shifts where it occurs, including the appropriate sampling of the shift handover. The ma
audit shall include an audit of the effective implementation of the process risk analysis (such as PFME
associated documents.
The organization shall audit products using customer-specific required approaches at appropriate stag
delivery to verify conformity to specified requirements. Where not defined by the customer, the organ
approach to be used.
The organization shall conduct internal audits at planned intervals to provide information on whether
management system:
a) conforms to:
1) the organization’s own requirements for its environmental management system;
2) the requirements of this International Standard;
b) is effectively implemented and maintained.
The organization shall establish, implement and maintain an internal audit programme(s), including th
responsibilities, planning requirements and reporting of its internal audits.
When establishing the internal audit programme, the organization shall take into consideration the en
of the processes concerned, changes affecting the organization and the results of previous audits.
The organization shall:
a) define the audit criteria and scope for each audit;
b) select auditors and conduct audits to ensure objectivity and the impartiality of the audit process;
c) ensure that the results of the audits are reported to relevant management.
The organization shall retain documented information as evidence of the implementation of the audit
audit results.
Linkage to ACX QMS for SCR
x
Customer o9.7.3
Special
Process
Require
ments
x •
BorgWarn
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require
Suppliers
with
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4.4.1 The organization shall establish, implement, maintain and continually improve a quality manage
the processes needed and their interactions, in accordance with the requirements of this Internationa
The organization shall determine the processes needed for the quality management system and their
the organization, and shall:
a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and related pe
needed to ensure the effective operation and control of these processes;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes achie
results;
h) improve the processes and the quality management system.
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The organization shall use a multidisciplinary approach including risk identification and risk mitigation
and improving plant, facility, and equipment plans
a) optimize material flow, material handling, and value-added use of floor space including control of n
b) facilitate synchronous material flow, as applicable;
c) implement cyber protection of equipment and systems supporting manufacturing.
Methods shall be developed and implemented to evaluate manufacturing feasibility for new product o
Manufacturing feasibility assessments shall include capacity planning. These methods shall also be ap
proposed changes to existing operations.
The organization shall maintain process effectiveness, including periodic re-evaluation relative to risk,
changes made during process approval, control plan maintenance (see Section 8.5.1.1), and verificati
Section 8.5.1.3).
Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to manag
9001, Section 9.3).
NOTE 1 These requirements should include the application of lean manufacturing principles.
NOTE 2 These requirements should apply to on-site supplier activities, as applicable.
The organization shall have a documented process to determine the use of appropriate error-proofi
Details of the method used shall be documented in the process risk analysis (such as PFMEA) and test
documented in the control plan. The process shall include the testing of error-proofing devices for fail
Records shall be maintained. Challenge parts, when used, shall be identified, controlled, verified, and
feasible. Error-proofing device failures shall have a reaction plan.
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10 SIS
7.1.5.3.2 External laboratory
IATF 16949 7 FAQ
14 FAQ
Description
tion
Back to Matrix Clause
An organization's internal laboratory facility shall have a defined scope that includes its capability to p
inspection, test, or calibration services. This laboratory scope shall be included in the quality managem
documentation.
The laboratory shall specify and implement, as a minimum, requirements for:
a) adequacy of the laboratory technical procedures;
b) competency of the laboratory personnel;
c) testing of the product;
d) capability to perform these services correctly, traceable to the relevant process standard (such as A
national or international standard(s) is available, the organization
shall define and implement a methodology to verify measurement system capability;
e) customer requirements, if any;
f) review of the related records.
NOTE Third-party accreditation to ISO/IEC 17025 (or equivalent) may be used to demonstrate the orga
laboratory conformity to this requirement.
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The organization shall use suitable means to identify outputs when it is necessary to ensure the confo
services.
The organization shall identify the status of outputs with respect to monitoring and measurement req
production and service provision.
The organization shall control the unique identification of the outputs when traceability is a requireme
documented information necessary to enable traceability.
NOTE Inspection and test status is not indicated by the location of product in the production flow unle
such as material in an automated production transfer process. Alternatives are permitted if the status
documented, and achieves the designated purpose.
The organization shall exercise care with property belonging to customers or external providers while
organization’s control or being used by the organization.
The organization shall identify, verify, protect and safeguard customers’ or external providers’ proper
incorporation into the products and services.
When the property of a customer or external provider is lost, damaged or otherwise found to be unsui
organization shall report this to the customer or external provider and retain documented informat
occurred.
NOTE A customer’s or external provider’s property can include materials, components, tools and equi
intellectual property and personal data.
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8.5.1.6 Management of
production tooling and
IATF 16949 manufacturing, test,
inspection tooling and
equipment
ISO 9001 7.1.5.2 Measurement
traceability
7.1.5.2.1
IATF 16949 Calibration/verification x
records
Description
The organization shall develop, implement, and maintain a documented total productive mainten
The organization shall provide resources for tool and gauge design, fabrication, and verification activi
service materials and for bulk materials, as applicable.
The organization shall establish and implement a system for production tooling management, whethe
organization or the customer, including:
The organization shall verify that customer-owned tools, manufacturing equipment, and test/inspectio
permanently marked in a visible location so that the ownership and application of each item can be d
The organization shall implement a system to monitor these activities if any work is outsourced
When measurement traceability is a requirement, or is considered by the organization to be an essen
confidence in the validity of measurement results, measuring equipment shall be:
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standard
international or national measurement standards; when no such standards exist, the basis used for ca
shall be retained as documented information;
b) identified in order to determine their status;
c) safeguarded from adjustments, damage or deterioration that would invalidate the calibration status
measurement results.
The organization shall determine if the validity of previous measurement results has been adversely a
equipment is found to be unfit for its intended purpose, and shall take appropriate action as necessar
NOTE A number or another identifier traceable to the device calibration record meets the intent of the
9001:2015.
The organization shall have a documented process for managing calibration/verification records. R
calibration/verification activity for all gauges and measuring and test equipment (including employee-
relevant for measuring, customer-owned equipment, or onsite supplier-owned equipment) needed to
conformity to internal requirements, legislative and regulatory requirements, and customer-defined re
retained.
The organization shall ensure that calibration/verification activities and records shall include the follow
a) revisions following engineering changes that impact measurement systems;
b) any out-of-specification readings as received for calibration/verification;
c) an assessment of the risk of the intended use of the product caused by the out-of-specification con
d) when a piece of inspection measurement and test equipment is found to be out of calibration or de
planned verification or calibration or during its use, documented information on the validity of previou
obtained with this piece of inspection measurement and test equipment shall be retained, including th
last calibration date and the next due date on the calibration report;
e) notification to the customer if suspect product or material has been shipped;
f) statements of conformity to specification after calibration/verification;
g) verification that the software version used for product and process control is as specified;
h) records of the calibration and maintenance activities for all gauging (including employee owned eq
owned equipment, or on-site supplier-owned equipment);
i) production-related software verification used for product and process control (including software ins
owned equipment, customer-owned equipment, or on-site supplier-owned equipment).
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The organization shall ensure that externally provided processes, products and services do not advers
organization’s ability to consistently deliver conforming products and services to its customers.
The organization shall have a documented process to identify outsourced processes and to select th
controls used to verify conformity of externally provided products, processes, and services to internal
external customer requirements. The process shall include the criteria and actions to escalate or redu
of controls and development activities based on supplier performance and assessment of product, ma
Where characteristics or components “pass through” the organization’s quality management system w
controls, the organization shall ensure that the appropriate controls are in place at the point of manuf
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8.4.1.1 General —
IATF 16949
supplemental
8.4.1.3 Customer-directed
IATF 16949 sources (also known as
"Directed Buy")
8.4.2.3 Supplier quality 8 SIS
management system
IATF 16949
development
8.4.2.3.1 Automotive
product-related software or
IATF 16949
automotive products with
embedded software
2 SIS
4.4.1.2 Product safety
IATF 16949 4 FAQ x
13 FAQ
Description
The organization shall ensure that externally provided processes, products and services conform to re
The organization shall determine the controls to be applied to externally provided processes, products
a) products and services from external providers are intended for incorporation into the organization’s
services;
b) products and services are provided directly to the customer(s) by external providers on behalf of th
c) a process, or part of a process, is provided by an external provider as a result of a decision by the o
The organization shall determine and apply criteria for the evaluation, selection, monitoring of
performance, and re-evaluation of external providers, based on their ability to provide processes or
products and services in accordance with requirements. The organization shall retain documented
information of these activities and any necessary actions arising from the evaluations.
The organization shall include all products and services that affect customer requirements such as sub
sorting, rework, and calibration services in the scope of their definition of externally provided product
services.
The organization shall have a documented supplier selection process. The selection process shall inc
a) an assessment of the selected supplier's risk to product conformity and uninterrupted supply of the
to their customers;
b) relevant quality and delivery performance;
c) an evaluation of the supplier's quality management system;
d) multidisciplinary decision making; and
e) an assessment of software development capabilities, if applicable.
Other supplier selection criteria that should be considered include the following: volume of automotiv
as a percentage of total business);
- financial stability;
- purchased product, material, or service complexity;
- required technology (product or process);
- adequacy of available resources (e.g., people, infrastructure);
- design and development capabilities (including project management);
- manufacturing capability;
- change management process;
- business continuity planning (e.g., disaster preparedness, contingency planning);
- logistics process;
- customer service.
When specified by the customer, the organization shall purchase products, materials, or services from
sources. All requirements of Section 8.4 (except the requirements in IATF 16949, Section 8.4.1.2) are
organization's control of customer-directed sources unless specific agreements are otherwise defined
the organization and the customer.
The organization shall require their suppliers of automotive products and services to develop, implem
quality management system (QMS) with the ultimate objective of eligible organizations becoming cer
QMS Standard. Using a risk-based model, the organization shall define a minimum acceptable level of
target QMS development level for each supplier. Unless otherwise authorized by the customer [e.g., it
certified to ISO 9001 is the initial minimum acceptable level of development. Based on current perform
risk to the customer, the objective is to move suppliers through the following QMS development progr
The organization shall require their suppliers of automotive product-related software, or automotive p
software, to implement and maintain a process for software quality assurance for their products. A so
assessment methodology shall be utilized to assess the supplier's software development process. Usin
risk and potential impact to the customer, the organization shall require the supplier to retain docume
software development capability self-assessment
The organization shall have a documented process and criteria to evaluate supplier performance in
conformity of externally provided products, processes, and services to internal and external customer
minimum, the following supplier performance indicators shall be monitored:
Based on a risk analysis, including product safety/regulatory requirements, performance of the suppli
level, at a minimum, the organization shall document the criteria for determining the need, type, fre
second-party audits.
If the scope of the second-party audit is to assess the supplier's quality management system, then the
consistent with the automotive process approach.
NOTE Guidance may be found in the IATF Auditor Guide and ISO 19011.
The organization shall determine the priority, type, extent, and timing of required supplier developme
suppliers. Determination inputs shall include but are not limited to the following:
The organization shall implement actions necessary to resolve open (unsatisfactory) performance issu
opportunities for continual improvement.
The organization shall ensure the adequacy of requirements prior to their communication to the
external provider.
NOTE: Special approval of safety related requirements or documents may be required by the custom
internal processes. Special approval is an additional approval by the function (typically the customer)
to approve such documents with safety-related content.
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7.1.6 Organizational
ISO 9001
knowledge
ISO 9001
7.2 Competence x
7.2.1 Competence -
IATF 16949 22 SIS x
supplemental
7.2.2 Competence-on-the-job
IATF 16949
training
ISO 9001
7.3 Awareness
7.3.1 Awareness -
IATF 16949 x
supplemental
5.1.1.1 Corporate
IATF 16949
responsibility
9.1.1.3 Application of
IATF 16949
statistical concepts
The organization shall determine the knowledge necessary for the operation of its processes and to ac
products and services.
This knowledge shall be maintained and be made available to the extent necessary.
When addressing changing needs and trends, the organization shall consider its current knowledge
and determine how to acquire or access any necessary additional knowledge and required updates.
a) internal sources (e.g. intellectual property; knowledge gained from experience; lessons learned from
failures and successful projects; capturing and sharing undocumented knowledge and experience; the
improvements in processes, products and services);
b) external sources ( e.g. standards; academia; conferences; gathering knowledge from customers or
a) determine the necessary competence of person(s) doing work under its control that affects the per
effectiveness of the quality management system;
b) ensure that these persons are competent on the basis of appropriate education, training, or experie
c) where applicable, take actions to acquire the necessary competence, and evaluate the effectivenes
d) retain appropriate documented information as evidence of competence.
NOTE Applicable actions can include, for example, the provision of training to, the mentoring of, or the
of currently employed persons; or the hiring or contracting of competent persons.
The organization shall establish and maintain a documented process(es) for identifying training
awareness (see Section 7.3.1) and achieving competence of all personnel performing activities affecti
and process requirements. Personnel performing specific assigned tasks shall be qualified, as required
attention to the satisfaction of customer requirements. To reduce or eliminate risks to the organizatio
awareness shall also include information about prevention relevant for the organization’s working env
employees’ responsibilities, such as recognizing the symptoms of pending equipment failure and/or a
The organization shall provide on-the-job training (which shall include customer requirements training
new or modified responsibilities affecting conformity to quality requirements, internal requirements, r
requirements; this shall include contract or agency personnel.
The level of detail required for on-the-job training shall be commensurate with the level of education t
and the complexity of the task(s) they are required to perform for their daily work. Persons whose wor
be informed about the consequences of nonconformity to customer requirements.
The organization shall ensure that persons doing work under the organization’s control are aware of:
The organization shall maintain documented information that demonstrates that all employees are
on product quality and the importance of their activities in achieving, maintaining, and improving qua
requirements and the risks involved for the customer with nonconforming product.
The organization shall define and implement corporate responsibility policies, including at a minimum
an employee code of conduct, and an ethics escalation policy ("whistle-blowing policy").
The quality policy shall:
The organization shall have a documented process(es) to verify that internal auditors are compete
requirements defined by the organization and/or customer-specific requirements. For additional guida
competencies, refer to ISO 19011.
Quality management system auditors shall be able to demonstrate the following minimum competenc
a) understanding of the automotive process approach for auditing, including risk-based thinking;
b) understanding of applicable customer-specific requirements;
c) understanding of applicable ISO 9001 and IATF 16949 requirements related to the scope of
the audit;
d) understanding of applicable core tool requirements related to the scope of the audit;
e) understanding how to plan, conduct, report, and close out audit findings.
At a minimum, manufacturing process auditors shall demonstrate technical understanding of the relev
process(es) to be audited, including process risk analysis (such as PFMEA) and control plan. At a minim
shall demonstrate competence in understanding product requirements and use of relevant measuring
verify product conformity.
If the organization’s personnel provide the training to achieve competency, documented informatio
demonstrate the trainer’s competency with the above requirements.
The organization shall ensure that product with unidentified or suspect status is classified and control
product. The organization shall ensure that all appropriate manufacturing personnel receive training f
suspect and nonconforming product.
Statistical concepts, such as variation, control (stability), process capability, and the consequences of
be understood and used by employees involved in the collection, analysis, and management of statist
The organization shall ensure that persons doing work under the organization’s control are aware of:
a) the environmental policy;
b) the significant environmental aspects and related actual or potential environmental impacts assoc
c) their contribution to the effectiveness of the environmental management system, including the be
environmental performance;
d) the implications of not conforming with the environmental management system requirements, inc
organization’s compliance obligations.
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ISO 9001
7.1.2 People
Description
The organization shall determine and provide the persons necessary for the effective implementation
management system and for the operation and control of its processes.
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ISO 9001
8.5.4 Preservation
8.5.4.1 Preservation —
IATF 16949
supplemental
Description
The organization shall preserve the outputs during production and service provision, to the extent nec
conformity to requirements.
NOTE Preservation can include identification, handling, contamination control, packaging, storage, tra
transportation, and protection
Preservation shall include identification, handling, contamination control, packaging, storage, transmi
and protection.
Preservation shall apply to materials and components from external and/or internal providers from rec
including shipment and until delivery to acceptance by the customer.
In order to detect deterioration, the organization shall assess at appropriate planned intervals the con
stock, the place/type of storage container, and the storage environment. The organization shall use an
system to optimize inventory turns over time and ensure stock rotation, such as “first-in-first-out" (FIF
The organization shall ensure that obsolete product is controlled in a manner similar to that of noncon
Organizations shall comply with preservation, packaging, shipping, and labeling requirements as prov
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ISO 9001
8.5.4 Preservation
8.5.4.1 Preservation —
IATF 16949
supplemental
Description
The organization shall preserve the outputs during production and service provision, to the extent nec
conformity to requirements.
NOTE Preservation can include identification, handling, contamination control, packaging, storage, tra
transportation, and protection
Preservation shall include identification, handling, contamination control, packaging, storage, transmi
and protection.
Preservation shall apply to materials and components from external and/or internal providers from rec
including shipment and until delivery to acceptance by the customer.
In order to detect deterioration, the organization shall assess at appropriate planned intervals the con
stock, the place/type of storage container, and the storage environment. The organization shall use an
system to optimize inventory turns over time and ensure stock rotation, such as “first-in-first-out" (FIF
The organization shall ensure that obsolete product is controlled in a manner similar to that of noncon
Organizations shall comply with preservation, packaging, shipping, and labeling requirements as prov
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8.5.4 Preservation
8.5.4.1 Preservation —
IATF 16949
supplemental
Description
The organization shall preserve the outputs during production and service provision, to the extent nec
conformity to requirements.
NOTE Preservation can include identification, handling, contamination control, packaging, storage, tra
transportation, and protection
Preservation shall include identification, handling, contamination control, packaging, storage, transmi
and protection.
Preservation shall apply to materials and components from external and/or internal providers from rec
including shipment and until delivery to acceptance by the customer.
In order to detect deterioration, the organization shall assess at appropriate planned intervals the con
stock, the place/type of storage container, and the storage environment. The organization shall use an
system to optimize inventory turns over time and ensure stock rotation, such as “first-in-first-out" (FIF
The organization shall ensure that obsolete product is controlled in a manner similar to that of noncon
Organizations shall comply with preservation, packaging, shipping, and labeling requirements as prov
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ISO 9001
8.5.4 Preservation
8.5.4.1 Preservation —
IATF 16949
supplemental
Description
The organization shall preserve the outputs during production and service provision, to the extent nec
conformity to requirements.
NOTE Preservation can include identification, handling, contamination control, packaging, storage, tra
transportation, and protection
Preservation shall include identification, handling, contamination control, packaging, storage, transmi
and protection.
Preservation shall apply to materials and components from external and/or internal providers from rec
including shipment and until delivery to acceptance by the customer.
In order to detect deterioration, the organization shall assess at appropriate planned intervals the con
stock, the place/type of storage container, and the storage environment. The organization shall use an
system to optimize inventory turns over time and ensure stock rotation, such as “first-in-first-out" (FIF
The organization shall ensure that obsolete product is controlled in a manner similar to that of noncon
Organizations shall comply with preservation, packaging, shipping, and labeling requirements as prov
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8.5.4 Preservation
8.5.4.1 Preservation —
IATF 16949
supplemental
Valmet
CSR
Communicated by e-mail
Description
The organization shall preserve the outputs during production and service provision, to the extent nec
conformity to requirements.
NOTE Preservation can include identification, handling, contamination control, packaging, storage, tra
transportation, and protection
Preservation shall include identification, handling, contamination control, packaging, storage, transmi
and protection.
Preservation shall apply to materials and components from external and/or internal providers from rec
including shipment and until delivery to acceptance by the customer.
In order to detect deterioration, the organization shall assess at appropriate planned intervals the con
stock, the place/type of storage container, and the storage environment. The organization shall use an
system to optimize inventory turns over time and ensure stock rotation, such as “first-in-first-out" (FIF
The organization shall ensure that obsolete product is controlled in a manner similar to that of noncon
Organizations shall comply with preservation, packaging, shipping, and labeling requirements as prov
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The organization shall use a multidisciplinary approach including risk identification and risk mitigation
and improving plant, facility, and equipment plans
a) optimize material flow, material handling, and value-added use of floor space including control of n
b) facilitate synchronous material flow, as applicable;
c) implement cyber protection of equipment and systems supporting manufacturing.
Methods shall be developed and implemented to evaluate manufacturing feasibility for new product o
Manufacturing feasibility assessments shall include capacity planning. These methods shall also be ap
proposed changes to existing operations.
The organization shall maintain process effectiveness, including periodic re-evaluation relative to risk,
changes made during process approval, control plan maintenance (see Section 8.5.1.1), and verificati
Section 8.5.1.3).
Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to manag
9001, Section 9.3).
NOTE 1 These requirements should include the application of lean manufacturing principles.
NOTE 2 These requirements should apply to on-site supplier activities, as applicable.
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The organization shall ensure that externally provided processes, products and services conform to re
The organization shall determine the controls to be applied to externally provided processes, products
a) products and services from external providers are intended for incorporation into the organization’s
services;
b) products and services are provided directly to the customer(s) by external providers on behalf of th
c) a process, or part of a process, is provided by an external provider as a result of a decision by the o
The organization shall determine and apply criteria for the evaluation, selection, monitoring of
performance, and re-evaluation of external providers, based on their ability to provide processes or
products and services in accordance with requirements. The organization shall retain documented
information of these activities and any necessary actions arising from the evaluations.
The organization shall ensure the adequacy of requirements prior to their communication to the
external provider.
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The organization shall have a documented process and criteria to evaluate supplier performance in
conformity of externally provided products, processes, and services to internal and external customer
minimum, the following supplier performance indicators shall be monitored:
tion
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ISO 9001
8.5.4 Preservation
8.5.4.1 Preservation —
IATF 16949
supplemental
9.1.2.1 Customer satisfaction
IATF 16949
— supplemental
Valmet
CSR
Communicated by e-mail
Description
8.2.3.1 The organization shall ensure that it has the ability to meet the requirements for products and
customers. The organization shall conduct a review before committing to supply products and service
include:
a) requirements specified by the customer, including the requirements for delivery and post delivery a
b) requirements not stated by the customer, but necessary for the specified or intended use, when kn
c) requirements specified by the organization;
d) statutory and regulatory requirements applicable to the products and services;
e) contract or order requirements differing from those previously expressed
The organization shall ensure that contract or order requirements differing from those previously
defined are resolved.
The customer’s requirements shall be confirmed by the organization before acceptance, when the
customer does not provide a documented statement of their requirements.
NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead
review can cover relevant product information, such as catalogues.
The organization shall preserve the outputs during production and service provision, to the extent nec
conformity to requirements.
NOTE Preservation can include identification, handling, contamination control, packaging, storage, tra
transportation, and protection
Preservation shall include identification, handling, contamination control, packaging, storage, transmi
and protection.
Preservation shall apply to materials and components from external and/or internal providers from rec
including shipment and until delivery to acceptance by the customer.
In order to detect deterioration, the organization shall assess at appropriate planned intervals the con
stock, the place/type of storage container, and the storage environment. The organization shall use an
system to optimize inventory turns over time and ensure stock rotation, such as “first-in-first-out" (FIF
The organization shall ensure that obsolete product is controlled in a manner similar to that of noncon
Organizations shall comply with preservation, packaging, shipping, and labeling requirements as prov
Customer satisfaction with the organization shall be monitored through continual evaluation of interna
performance indicators to ensure compliance to the product and process specifications and other cust
Performance indicators shall be based on objective evidence and include but not be limited to the foll
a) delivered part quality performance;
b) customer disruptions;
c) field returns, recalls, and warranty (where applicable);
d) delivery schedule performance (including incidents of premium freight);
e) customer notifications related to quality or delivery issues, including special status.
The organization shall monitor the performance of manufacturing processes to demonstrate complian
requirements for product quality and process efficiency. The monitoring shall include the review of cu
data including online customer portals and customer scorecards, where provided.
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4.4.1.1 Conformance of
IATF 16949 23 SIS
products and processes
ISO 9001
5.1.2 Customer focus
ISO14001
6.1.3 Compliance obligations x
The organization shall ensure conformance of all products and processes, including service parts and
outsourced, to all applicable customer, statutory, and regulatory requirements (see Section 8.4.2.2).
The organization shall ensure conformance of all products and processes, including service parts and
outsourced, to all applicable customer, statutory, and regulatory requirements, including conformance
requirements (see Section 8.4.2.2).
Top management shall demonstrate leadership and commitment with respect to customer focus by e
a) customer and applicable statutory and regulatory requirements are determined, understood and co
b) the risks and opportunities that can affect conformity of products and services and the ability to en
satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is maintained
When determining the requirements for the products and services to be offered to customers, the
organization shall ensure that:
a) the requirements for the products and services are defined, including:
1) any applicable statutory and regulatory requirements;
2) those considered necessary by the organization;
b) the organization can meet the claims for the products and services it offers.
The organization shall establish, implement and maintain the processes needed to evaluate fulfilment
obligations.
The organization shall:
a) determine the frequency that compliance will be evaluated;
b) evaluate compliance and take action if needed;
c) maintain knowledge and understanding of its compliance status.
The organization shall retain documented information as evidence of the compliance evaluation re
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10 Improvement
ISO 9001
10.1 General
ISO 9001
10.3 Continual improvement
10.3.1 Continual
IATF 16949 x
improvement - supplemental
The organization shall determine and select opportunities for improvement and implement any neces
customer requirements and enhance customer satisfaction.
NOTE Examples of improvement can include correction, corrective action, continual improvement,
breakthrough change, innovation and re-organization.
The organization shall continually improve the suitability, adequacy and effectiveness of the quality.
The organization shall consider the results of analysis and evaluation, and the outputs from
management review, to determine if there are needs or opportunities that shall be addressed as part
continual improvement.
The organization shall have a documented process for continual improvement. The organization s
process the following:
a) identification of the methodology used, objectives, measurement, effectiveness, and
documented information;
b) a manufacturing process improvement action plan with emphasis on the reduction of process
variation and waste;
c) risk analysis (such as FMEA).
NOTE Continual improvement is implemented once manufacturing processes are statistically capable
product characteristics are predictable and meet customer requirements.
The organization shall determine opportunities for improvement (see 9.1, 9.2 and 9.3) and implement
achieve the intended outcomes of its environmental management system.
The organization shall continually improve the suitability, adequacy and effectiveness of the environm
system to enhance environmental performance.
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8.2.1.1 Customer
IATF 16949 communication –
supplemental
ISO 9001
8.5.5 Post-delivery activities
8.5.5.1 Feedback of
IATF 16949
information from service
10.2.5 Warranty
IATF 16949
management systems
Description
Written or verbal communication shall be in the language agreed with the customer. The organization
communicate necessary information, including data in a customer-specified computer language and f
aided design data, electronic data interchange).
The organization shall meet requirements for post-delivery activities associated with the products and
In determining the extent of post-delivery activities that are required, the organization shall consider:
a) statutory and regulatory requirements;
b) the potential undesired consequences associated with its products and services;
c) the nature, use and intended lifetime of its products and services;
d) customer requirements;
e) customer feedback.
NOTE Post-delivery activities can include actions under warranty provisions, contractual obligations su
as maintenance services, and supplementary services such as recycling or final disposal
The organization shall ensure that a process for communication of information on service concerns to
handling, logistics, engineering, and design activities is established, implemented, and maintained.
NOTE 1 The intent of the addition of "service concerns” to this sub-clause is to ensure that the organiz
nonconforming product(s) and material(s) that may be identified at the customer location or in the fie
NOTE 2 "Service concerns" should include the results of field failure test analysis (see Section 10.2.6)
When there is a service agreement with the customer, the organization shall:
a) verify that the relevant service centres comply with applicable requirements;
b) verify the effectiveness of any special purpose tools or measurement equipment
c) ensure that all service personnel are trained in applicable requirements.
When the organization is required to provide warranty for their product(s), the organization shall impl
management process. The organization shall include in the process a method for warranty part analys
trouble found). When specified by the customer, the organization shall implement the required warran
process.
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Top management shall review the organization’s quality management system, at planned intervals, to
suitability, adequacy, effectiveness and alignment with the strategic direction of the organization.
Management review shall be conducted at least annually. The frequency of management review(s) sh
on risk to compliance with customer requirements resulting from internal or external changes impacti
management system and performance-related issues.
The management review shall be planned and carried out taking into consideration:
a) the status of actions from previous management reviews;
b) changes in external and internal issues that are relevant to the quality management system;
c) information on the performance and effectiveness of the quality management system, including tre
1) customer satisfaction and feedback from relevant interested parties;
2) the extent to which quality objectives have been met;
3) process performance and conformity of products and services;
4) nonconformities and corrective actions;
5) monitoring and measurement results;
6) audit results;
7) the performance of external providers;
d) the adequacy of resources;
e) the effectiveness of actions taken to address risks and opportunities (see 6.1);
f) opportunities for improvement.
The outputs of the management review shall include decisions and actions related to:
a) opportunities for improvement;
b) any need for changes to the quality management system;
c) resource needs.
The organization shall retain documented information as evidence of the results of management revie
Top management shall document and implement an action plan when customer performance targe
Top management shall review the organization’s environmental management system, at planned inte
continuing suitability, adequacy and effectiveness.
The management review shall include consideration of:
a) the status of actions from previous management reviews;
b) changes in:
1) external and internal issues that are relevant to the environmental management system;
2) the needs and expectations of interested parties, including compliance obligations;
3) its significant environmental aspects;
4) risks and opportunities
c) the extent to which environmental objectives have been achieved;
d) information on the organization’s environmental performance, including trends in:
1) nonconformities and corrective actions;
2) monitoring and measurement results;
3) fulfilment of its compliance obligations;
4) audit results;
e) adequacy of resources;
f) relevant communication(s) from interested parties, including complaints;
g) opportunities for continual improvement.
The outputs of the management review shall include:
— conclusions on the continuing suitability, adequacy and effectiveness of the environmental manage
— decisions related to continual improvement opportunities; — decisions related to any need for chan
environmental management system, including resources; — actions, if needed, when environmental o
achieved;
— opportunities to improve integration of the environmental management system with other business
— any implications for the strategic direction of the organization.
The organization shall retain documented information as evidence of the results of management re
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6 Planning
ISO 9001 6.1 Actions to address risks
and opportunities
6.1.1
When planning for the quality management system, the organization shall consider the issues referre
requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed t
a) give assurance that the quality management system can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve improvement.
NOTE 1 Options to address risks can include avoiding risk, taking risk in order to pursue an opportunit
source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decisi
NOTE 2 Opportunities can lead to the adoption of new practices, launching new products, opening new
new customers, building partnerships, using new technology and other desirable and viable possibiliti
organization’s or its customers’ needs.
a) lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap, an
b) cyber-attack threats to information technology systems.
The organization shall retain documented information as evidence of the results of risk analysis.
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9 Performance evaluation
9.1 Monitoring,
ISO 9001
measurement, analysis and x
evaluation
9.1.1 General
ISO 9001
9.1.3 Analysis and evaluation
The organization shall evaluate the performance and the effectiveness of the quality management sys
The organization shall retain appropriate documented information as evidence of the results.
Top management shall review effectiveness and efficiency of the quality management system to eval
organization’s quality management system. The results of the process review activities shall be includ
management review (see Section 9.3.2.1.).
The organization shall analyse and evaluate appropriate data and information arising from monitoring
Trends in quality and operational performance shall be compared with progress toward objectives and
support prioritization of actions for improving customer satisfaction.
The organization shall monitor, measure, analyse and evaluate its environmental performance. The or
determine:
a) what needs to be monitored and measured;
b) the methods for monitoring, measurement, analysis and evaluation, as applicable, to ensure valid
c) the criteria against which the organization will evaluate its environmental performance, and appro
d) when the monitoring and measuring shall be performed;
e) when the results from monitoring and measurement shall be analysed and evaluated.
The organization shall ensure that calibrated or verified monitoring and measurement equipment is u
appropriate.
The organization shall evaluate its environmental performance and the effectiveness of the environm
system.
The organization shall communicate relevant environmental performance information both internally
identified in its communication process(es) and as required by its compliance obligations.
The organization shall retain appropriate documented information as evidence of the monitoring, mea
evaluation results.
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ISO 9001
9.1.2 Customer satisfaction
The organization shall monitor customers’ perceptions of the degree to which their needs and expecta
fulfilled. The organization shall determine the methods for obtaining, monitoring and reviewing this in
NOTE Examples of monitoring customer perceptions can include customer surveys, customer feedbac
and services, meetings with customers, market-share analysis, compliments, warranty claims and dea
Customer satisfaction with the organization shall be monitored through continual evaluation of interna
performance indicators to ensure compliance to the product and process specifications and other cust
Performance indicators shall be based on objective evidence and include but not be limited to the foll
a) delivered part quality performance;
b) customer disruptions;
c) field returns, recalls, and warranty (where applicable);
d) delivery schedule performance (including incidents of premium freight);
e) customer notifications related to quality or delivery issues, including special status.
The organization shall monitor the performance of manufacturing processes to demonstrate complian
requirements for product quality and process efficiency. The monitoring shall include the review of cu
data including online customer portals and customer scorecards, where provided.
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The organization shall ensure the confidentiality of customer-contracted products and projects under
related product information.
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ISO 9001
5.1.2 Customer focus
Description
Top management shall demonstrate leadership and commitment with respect to customer focus by e
a) customer and applicable statutory and regulatory requirements are determined, understood and co
b) the risks and opportunities that can affect conformity of products and services and the ability to en
satisfaction are determined and addressed;
c) the focus on enhancing customer satisfaction is maintained
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3 SIS
IATF 16949 6.1.2.3 Contingency plans 17 SIS x
29 FAQ
Valmet
a) identify and evaluate internal and external risks to all manufacturing processes and infrastructure e
maintain production output and to ensure that customer requirements are met;
b) define contingency plans according to risk and impact to the customer;
prepare contingency plans for continuity of supply in the event of any of the following, but not limited
failures (also see Section 8.5.6.1.1); interruption from externally provided products, processes, and se
disasters; fire; pandemics; utility interruptions; cyber-attacks on information technology systems; labo
infrastructure disruptions;
d) include, as a supplement to the contingency plans, a notification process to the customer and othe
the extent and duration of any situation impacting customer operations;
e) periodically test the contingency plans for effectiveness (e.g. simulations, as appropriate);
cybersecuritg testing may include a simulation of a cyber-attack, regular monitoring for specific threa
dependencies and prioritization of vulnerabilities. The testing is appropriate to the risk of associated c
Note: cybersecurity testing may be managed internally by the organization or subcontracted as appro
f) conduct contingency plan reviews (at a minimum annually) using a multidisciplinary team
including top management, and update as required
g) document the contingency plans and retain documented information describing any revision(s),
who authorized the change(s).
h) include in contingency plans the development and implementation of appropriate employee trainin
The contingency plans shall include provisions to validate that the manufactured product continues to
specifications after the re-start of production following an emergency in which production was stoppe
shutdown processes were not followed.
The organization shall establish, implement and maintain the processes needed to prepare for and re
emergency situations identified in 6.1.1.
The organization shall:
a) prepare to respond by planning actions to prevent or mitigate adverse environmental impacts from
b) respond to actual emergency situations;
c) take action to prevent or mitigate the consequences of emergency situations, appropriate to the m
emergency and the potential environmental impact;
d) periodically test the planned response actions, where practicable;
e) periodically review and revise the process(es) and planned response actions, in particular after the
emergency situations or tests;
f) provide relevant information and training related to emergency preparedness and response, as ap
interested parties, including persons working under its control.
The organization shall maintain documented information to the extent necessary to have confidence t
(are) carried out as planned.
6.9 Contingency Plans
6.9.1 The Supplier shall prepare contingency plans to satisfy BorgWarner and IATF 16949 requ
of an emergency such as utility interruptions, labor shortages, key equipment failure and field r
contingency plan shall define preventative measures, immediate response, recovery steps and tim
production of quality product.
Contingency plans shall include at minimum:
• Defined roles and responsibilities
• Response organization and contact information
• Initial actions
• Escalation procedures
• Communication Plans
• Recovery plans
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ISO 9001
7.4 Communication
The organization shall determine the internal and external communications relevant to the quality ma
including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates.
The organization shall establish, implement and maintain the processes needed for internal and exter
relevant to the environmental management system, including:
a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate.
When establishing its communication process{es), the organization shall:
— take into account its compliance obligations;
— ensure that environmental information communicated is consistent with information generated wi
management system, and is reliable.
The organization shall respond to relevant communications on its environmental management system
The organization shall retain documented information as evidence of its communications, as appro
The organization shall:
a) internally communicate information relevant to the environmental management system among th
functions of the organization, including changes to the environmental management system, as approp
b) ensure its communication process{es) enable{s) persons doing work under the organization’s con
continual improvement.
The organization shall externally communicate information relevant to the environmental managemen
by the organization’s communication process{es) and as required by its compliance obligations.
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The organization shall maintain its premises in a state of order, cleanliness, and repair that is consiste
manufacturing process needs.
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The organization shall determine, provide and maintain the environment necessary for the operation
of its processes and to achieve conformity of products and services.
NOTE A suitable environment can be a combination of human and physical factors, such as:
a) social (e.g. non-discriminatory, calm, non-confrontational);
b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective);
c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise).
These factors can differ substantially depending on the products and services provided.
NOTE Where third-party certification to ISO 45001 (or equivalent) is recognized, it may be used to dem
organization's conformity to the personnel safety aspects of this requirement
The organization shall establish, implement, control and maintain the processes needed to meet envir
system requirements, and to implement the actions identified in 6.1 and 6.2, by:
— establishing operating criteria for the process(es); — implementing control of the process(es), in ac
operating criteria.
NOTE Controls can include engineering controls and procedures. Controls can be implemented followi
elimination, substitution, administrative) and can be used individually or in combination.
The organization shall control planned changes and review the consequences of unintended changes,
any adverse effects, as necessary.
The organization shall ensure that (an) outsourced process(es) is (are) controlled or influenced. The ty
or influence to be applied to the process(es) shall be defined within the environmental management s
Consistent with a life cycle perspective, the organization shall:
a) establish controls, as appropriate, to ensure that its environmental requirement(s) is (are) address
development process for the product or service, considering each stage of its life cycle;
b) determine its environmental requirement(s) for the procurement of products and services, as app
c) communicate its relevant environmental requirement(s) to external providers, including contracto
d) consider the need to provide information about potential significant environmental impacts associ
transportation or delivery, use, end-of-life treatment and final disposal of its products and services.
The organization shall maintain documented information to the extent necessary to have confidence t
(have) been carried out as planned.
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7 Support
ISO 9001
7.1 Resources
7.1.1 General
ISO 9001
7.1.2 People
ISO 14001
7.1Resources
Description
The organization shall determine and provide the resources needed for the establishment, implement
continual improvement of the quality management system.
The organization shall determine and provide the persons necessary for the effective implementation
management system and for the operation and control of its processes.
The organization shall determine and provide the resources needed for the establishment, implement
continual improvement of the environmental management system.
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ISO 9001
7.1.3 Infrastructure
The organization shall determine, provide and maintain the infrastructure necessary for the operation
achieve conformity of products and services.
The organization shall use a multidisciplinary approach including risk identification and risk mitigation
and improving plant, facility, and equipment plans
a) optimize material flow, material handling, and value-added use of floor space including control of n
b) facilitate synchronous material flow, as applicable; and
c) implement cyber protection of equipment and systems supporting manufacturing.
Methods shall be developed and implemented to evaluate manufacturing feasibility for new product o
Manufacturing feasibility assessments shall include capacity planning. These methods shall also be ap
proposed changes to existing operations.
The organization shall maintain process effectiveness, including periodic re-evaluation relative to risk,
changes made during process approval, control plan maintenance (see Section 8.5.1.1), and verificati
Section 8.5.1.3).
Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to manag
9001, Section 9.3).
NOTE 1 These requirements should include the application of lean manufacturing principles.
NOTE 2 These requirements should apply to on-site supplier activities, as applicable.
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5.3Organizational roles,
ISO 14001
responsibilities and
authorities
Description
Top management shall ensure that the responsibilities and authorities for relevant roles are assigned,
communicated and understood within the organization.
a) ensuring that the quality management system conforms to the requirements of this International S
b) ensuring that the processes are delivering their intended outputs;
c) reporting on the performance of the quality management system and on opportunities for improvem
particular to top management;
d) ensuring the promotion of customer focus throughout the organization;
e) ensuring that the integrity of the quality management system is maintained when changes to the q
system are planned and implemented.
Top management shall assign personnel with the responsibility and authority to ensure that customer
These assignments shall be documented. This includes but is not limited to the selection of special c
quality objectives and related training, corrective and preventive actions, product design and develop
logistics information, customer scorecards, and customer portals.
a) personnel responsible for conformity to product requirements have the authority to stop shipment
and stop production to correct quality problems;
NOTE Due to the process design in some industries, it might not always be possible to stop production
case, the affected batch must be contained and shipment to the customer prevented.
b) personnel with authority and responsibility for corrective action are promptly informed of products
conform to requirements to ensure that nonconforming product is not shipped to the customer and th
nonconforming product is identified and contained;
c) production operations across all shifts are staffed with personnel in charge of, or delegated respons
conformity to product requirements.
Top management shall ensure that the responsibilities and authorities for relevant roles are assigned
within the organization.
Top management shall assign the responsibility and authority for:
a) ensuring that the environmental management system conforms to the requirements of this Intern
b) reporting on the performance of the environmental management system, including environmenta
management.
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Top management shall identify process owners who are responsible for managing the organization's p
outputs. Process owners shall understand their roles and be competent to perform those roles (see ISO
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5 Leadership
ISO 9001 5.1 Leadership and
commitment
5.1.1 General
Top management shall demonstrate leadership and commitment with respect to the quality managem
a) taking accountability for the effectiveness of the quality management system;
b) ensuring that the quality policy and quality objectives are established for the quality management
compatible with the context and strategic direction of the organization;
c) ensuring the integration of the quality management system requirements into the organization’s bu
d) promoting the use of the process approach and risk-based thinking;
e) ensuring that the resources needed for the quality management system are available;
f) communicating the importance of effective quality management and of conforming to the quality m
requirements;
g) ensuring that the quality management system achieves its intended results;
h) engaging, directing and supporting persons to contribute to the effectiveness of the quality manag
i) promoting improvement;
j) supporting other relevant management roles to demonstrate their leadership as it applies to their a
Top management shall demonstrate leadership and commitment with respect to the environmental m
a) taking accountability for the effectiveness of the environmental management system;
b) ensuring that the environmental policy and environmental objectives are established and are com
direction and the context of the organization;
c) ensuring the integration of the environmental management system requirements into the organiz
processes;
d) ensuring that the resources needed for the environmental management system are available;
e) communicating the importance of effective environmental management and of conforming to the
management system requirements;
f) ensuring that the environmental management system achieves its intended outcomes;
g) directing and supporting persons to contribute to the effectiveness of the environmental managem
h) promoting continual improvement;
i) supporting other relevant management roles to demonstrate their leadership as it applies to their
NOTE Reference to “business” in this International Standard can be interpreted broadly to mean thos
to the purposes of the organization’s existence.
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6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes
needed for the quality management system.
6.2.2 When planning how to achieve its quality objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.
Top management shall ensure that quality objectives to meet customer requirements are defined, est
maintained for relevant functions, processes, and levels throughout the organization. The results of th
regarding interested parties and their relevant requirements shall be considered when the organizatio
(at a minimum) quality objectives and related performance targets (internal and external).
The organization shall establish environmental objectives at relevant functions and levels, taking into
organization’s significant environmental aspects and associated compliance obligations, and consider
opportunities.
The environmental objectives shall be:
a) consistent with the environmental policy;
b) measurable {if practicable);
c) monitored;
d) communicated;
e) updated as appropriate.
The organization shall maintain documented information on the environmental objectives
6.2.2 Planning actions to achieve environmental objectives
When planning how to achieve its environmental objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated, including indicators for monitoring progress toward achievemen
environmental objectives {see 9.1.1).
The organization shall consider how actions to achieve its environmental objectives can be integrated
business processes.
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5.2 Policy
ISO 9001
5.2.1 Establishing the quality x
policy
ISO 14001
5.2Environmental policy x
Description
Top management shall establish, implement and maintain a quality policy that:
a) is appropriate to the purpose and context of the organization and supports its strategic direction;
b) provides a framework for setting quality objectives;
c) includes a commitment to satisfy applicable requirements;
d) includes a commitment to continual improvement of the quality management system.
Top management shall establish, implement and maintain an environmental policy that, within the de
environmental management system:
a) is appropriate to the purpose and context of the organization, including the nature, scale and envi
activities, products and services;
b) provides a framework for setting environmental objectives;
c) includes a commitment to the protection of the environment, including prevention of pollution and
commitment{s) relevant to the context of the organization
d) includes a commitment to fulfil its compliance obligations;
e) includes a commitment to continual improvement of the environmental management system to e
performance.
The environmental policy shall:
— be maintained as documented information;
— be communicated within the organization;
— be available to interested parties.
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5.1.1.1 Corporate
IATF 16949
responsibility
Description
The organization shall define and implement corporate responsibility policies, including at a minimum
an employee code of conduct, and an ethics escalation policy ("whistle-blowing policy").
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4 Context of organization
ISO 9001
4.1 Understanding the
organization and its context
The organization shall determine external and internal issues that are relevant to its purpose and its s
that affect its ability to achieve the intended result(s) of its quality management system.
The organization shall monitor and review information about these external and internal issues.
NOTE 1 Issues can include positive and negative factors or conditions for consideration.
NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal
competitive, market, cultural, social and economic environments, whether international, nationa
NOTE 3 Understanding the internal context can be facilitated by considering issues related to values,
performance of the organization.
Due to their effect or potential effect on the organization’s ability to consistently provide products and
customer and applicable statutory and regulatory requirements, the organization shall determine:
a) the interested parties that are relevant to the quality management system;
b) the requirements of these interested parties that are relevant to the quality management system.
The organization shall monitor and review information about these interested parties and their releva
The organization shall determine the boundaries and applicability of the quality management system
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements of relevant interested parties referred to in 4.2;
c) the products and services of the organization.
The organization shall apply all the requirements of this International Standard if they are applicable w
scope of its quality management system.
The scope of the organization’s quality management system shall be available and be maintained
information. The scope shall state the types of products and services covered, and provide justificat
of this International Standard that the organization determines is not applicable to the scope of its qu
system.
Conformity to this International Standard may only be claimed if the requirements determined as not
affect the organization’s ability or responsibility to ensure the conformity of its products and services
customer satisfaction.
Supporting functions, whether on-site or remote (such as design centres, corporate headquarters, and
shall be included in the scope of the Quality Management System (QMS).
The only permitted exclusion for this Automotive QMS Standard relates to the product design and dev
within ISO 9001, Section 8.3. The exclusion shall be justified and maintained as documented inform
Section 7.5). Permitted exclusions do not include manufacturing process design.
The organization shall determine external and internal issues that are relevant to its purpose and that
achieve the intended outcomes of its environmental management system. Such issues shall include e
being affected by or capable of affecting the organization.
The organization shall determine:
a) the interested parties that are relevant to the environmental management system;
b) the relevant needs and expectations {i.e. requirements) of these interested parties;
c) which of these needs and expectations become its compliance obligations.
The organization shall determine the boundaries and applicability of the environmental management
scope.
When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the compliance obligations referred to in 4.2;
c) its organizational unit{s), function{s), and physical boundaries;
d) its activities, products and services;
e) its authority and ability to exercise control and influence.
Once the scope is defined, all activities, products and services of the organization within that scope ne
environmental management system.
The scope shall be maintained as documented information and be available to interested parties.
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8.5.1.7 Production
IATF 16949
scheduling
Description
The organization shall plan, implement and control the processes (see 4.4) needed to meet the requir
of products and services, and to implement the actions determined in Clause 6, by:
1) the processes;
2) the acceptance of products and services;
c) determining the resources needed to achieve conformity to the product and service requirements;
d) implementing control of the processes in accordance with the criteria;
e) determining, maintaining and retaining documented information to the extent necessary:
1) to have confidence that the processes have been carried out as planned;
2) to demonstrate the conformity of products and services to their requirements.
The output of this planning shall be suitable for the organization’s operations.
The organization shall control planned changes and review the consequences of unintended changes,
taking action to mitigate any adverse effects, as necessary.
When planning for product realization, the following topics shall be included:
The resources identified in ISO 9001, Section 8.1 c), refer to the required verification, validation, moni
inspection, and test activities specific to the product and the criteria for product acceptance.
The organization shall ensure that production is scheduled in order to meet customer orders/ demand
(JIT) and is supported by an information system that permits access to production information at key s
is order driven.
The organization shall include relevant planning information during production scheduling, e.g., custo
time delivery performance, capacity, shared loading (multi-part station), lead time, inventory level, pr
and calibration.
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2 SIS
4.4.1.2 Product safety
IATF 16949 4 FAQ x
13 FAQ
8.2.3.1.2 Customer-
IATF 16949 designated special
characteristics
8.3.3.3 Special
characteristics 6 SIS
IATF 16949 x
Borg Warner
Valmet
Valmet
The organization shall have documented processes for the management of product-safety related p
manufacturing processes, which shall include but not be limited to the following, where applicable:
NOTE: Special approval of safety related requirements or documents may be required by the custom
internal processes.
The organization shall conform to customer requirements for designation, approval documentation, an
characteristics
The organization shall use a multidisciplinary approach to establish, document, and implement its pr
special characteristics, including those determined by the customer and the risk analysis performed b
shall include the following:
a) documentation of all special characteristics product and/or manufacturing documents (as required)
(such as Process FMEA), control plans, and standardised work/operator instructions; special character
specific markings and are documented in the manufacturing documents which show the creation of, o
for these special characteristics;
b) development of control and monitoring strategies for special characteristics of products and produc
c) customer-specified approvals, when required;
d) compliance with customer-specified definitions and symbols or the organization's equivalent symbo
defined in a symbol conversion table. The symbol conversion table shall be submitted to the custome
9.7 Process Capability and Monitoring
Defined Part/Process Characteristics
• In addition to certain Customer Specific Requirements, certain characteristics can be deemed as i
require increased monitoring to ensure the quality of the parts. Those characteristics may be
special,
significant, high impact, major, or other, based on specific BorgWarner site requirements.
• The appropriate BorgWarner representative will identify these specific requirements, or charac
communication, specification, or product drawing.
Control of Above Defined Part/Process Characteristics
• The Supplier is expected to use statistical techniques to maintain a state of control and to im
capability on defined part/process characteristics.
• Unless otherwise specified by BorgWarner, a minimum 1.67 Ppk index is required for design
initial PPAP submission. For ongoing series production, a minimum 1.33 Ppk index is required.
• Suppliers must maintain the statistical data for all designated characteristics and must make the da
BorgWarner upon request. The Supplier may also be required to submit this data periodically to Bor
requested.
• Unless otherwise specified by BorgWarner, if the process does not meet the required capability
must supply a containment plan describing the 100% inspection method that prevents out of spec
being shipped to BorgWarner, and a Corrective Action Plan for capability improvement.
• BorgWarner representative may designate additional requirements.
• Lot traceability shall be maintained by the Supplier, unless otherwise specified by BorgWarner (se
Traceability Requirements” for specific details).
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The organization shall establish, implement, and maintain a product and manufacturing approval proc
requirements defined by the customer(s). The organization shall approve externally provided product
9001, Section 8.4.3, prior to submission of their part approval to the customer. The organization shall
product approval prior to shipment, if required by the customer. Records of such approval shall be ret
NOTE Product approval should be subsequent to the verification of the manufacturing process.
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The organization shall use suitable means to identify outputs when it is necessary to ensure the confo
services.
The organization shall identify the status of outputs with respect to monitoring and measurement req
production and service provision.
The organization shall control the unique identification of the outputs when traceability is a requireme
documented information necessary to enable traceability.
NOTE Inspection and test status is not indicated by the location of product in the production flow unle
such as material in an automated production transfer process. Alternatives are permitted if the status
documented, and achieves the designated purpose.
The purpose of traceability is to support identification of clear start and stop points for product receive
the field that may contain quality and/or safety-related nonconformities. Therefore, the organization s
identification and traceability processes as described below. These plans shall define the appropriate
processes, and methods by product, process, and manufacturing location that:
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8.2.3.1.2 Customer-
IATF 16949 designated special
characteristics
8.3.3.3 Special
characteristics 6 SIS
IATF 16949 x
Description
The organization shall conform to customer requirements for designation, approval documentation, an
characteristics
The organization shall use a multidisciplinary approach to establish, document, and implement its pr
special characteristics, including those determined by the customer and the risk analysis performed b
shall include the following:
a) documentation of all special characteristics product and/or manufacturing documents (as required)
(such as Process FMEA), control plans, and standardised work/operator instructions; special character
specific markings and are documented in the manufacturing documents which show the creation of, o
for these special characteristics;
b) development of control and monitoring strategies for special characteristics of products and produc
c) customer-specified approvals, when required;
d) compliance with customer-specified definitions and symbols or the organization's equivalent symbo
defined in a symbol conversion table. The symbol conversion table shall be submitted to the custome
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ISO 14001
6.1.4 Planning action
Description
To achieve the intended outcomes, including enhancing its environmental performance, the organizat
implement, maintain and continually improve an environmental management system, including the p
their interactions, in accordance with the requirements of this International Standard.
The organization shall consider the knowledge gained in 4.1 and 4.2 when establishing and maintainin
management system.
The organization shall establish, implement and maintain the processes needed to meet the requirem
in 6.1.1 to 6.1.4.
When planning for the environmental management system, the organization shall consider:
— the issues referred to in 4.1;
— the requirements referred to in 4.2;
— the scope of its environmental management system; and determine the risks and opportunities, re
— environmental aspects {see 6.1.2);
— compliance obligations {see 6.1.3);
— other issues and requirements, identified in 4.1 and 4.2; that need to be addressed to:
— give assurance that the environmental management system can achieve its intended outcomes;
— prevent, or reduce, undesired effects, including the potential for external environmental condition
organization;
— achieve continual improvement.
Within the scope of the environmental management system, the organization shall determine potenti
including those that can have an environmental impact.
The organization shall maintain documented information of its:
— risks and opportunities that need to be addressed;
— processes needed in 6.1.1 to 6.1.4, to the extent necessary to have confidence they are carried ou
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ISO 14001
6.1.2 Environmental aspects x
Description