Understanding, Knowledge,

and Awareness of
ISO 9001:2015
Dr Nigel H Croft
Chair, ISO/TC176/SC2 (Quality Systems)
June 23, 2014

TV SD

Presenter

Dr Nigel H Croft
Chair, ISO/TC176/SC2 (Quality Systems)
E-Mail: [email protected]

Currently holds senior management positions and serves as non-executive board

member of a number of commercial and non-profit organizations in Europe, the
Middle East, Asia and the Americas
Born and educated in the UK, but spent much of his professional life in Brazil.
Currently holds dual citizenship (Brazil / UK)
Member of the Brazilian Delegation to ISO/TC176 from 1995 to 2010, and was Task
Group Leader for the Introduction and Transition planning for ISO 9001:2000.
Served from 1999 to 2010 as the ISO/TC176 Liaison to ISO/CASCO and the IAF,
and was Founding Co-Chair of the ISO/IAF ISO 9000 Advisory Group.
Holds a First Class Honours Degree in Natural Sciences from Cambridge University
in the UK, and PhD in Materials Science from the University of Sheffield.

NOTE: Dr Croft is donating his professional fee for this Webinar to SOFT Support
Organization for Trisomy (http://trisomy.org)

TV SD

Slide 2

Understanding, Knowledge, and

Awareness of ISO 9001:2015
Dr. Nigel H Croft
Chair, ISO/TC176/SC2 (Quality Systems)

(C) Nigel H Croft 2014 - All rights reserved

Disclaimer

Any opinions expressed by the presenter are

personal viewpoints, and no formal endorsement
of ISO, IAF, ISO/TC176 or ISO/CASCO should
be implied
Information about the revision of ISO 9001 is not
final and should not be used for making changes
to existing quality management systems.

(C) Nigel H Croft 2014 - All rights reserved

Presentation Outline

Harmonization of ISOs management system

standards
Background and inputs to the revision of ISO 9001
ISO 9001:2015 what to expect

New structure
New requirements
Unchanged requirements
Deleted requirements

Transition arrangements
(C) Nigel H Croft 2014 - All rights reserved

BACKGROUND

(C) Nigel H Croft 2014 - All rights reserved

Overall Scenario of ISO/TC176

Development of generic quality management

system standards that have broad application:

all market sectors

both private and public organizations

Approx. 1.1 million certifications to ISO 9001

worldwide
BUT
Its about more than just certification

Certification to ISO 9001 should be a result of a wellimplemented quality management system!

(C) Nigel H Croft 2014 - All rights reserved

Quality Systems
(ISO 9001, ISO 9004
& others)
Fundamentals &
Vocabulary
(ISO 9000)

SC 1

WG 22
Interpretations

ISO/TC 176

SC 2

WG 23
Communications
& Product Support
(C) Nigel H Croft 2014 - All rights reserved

Supporting
technologies
(ISO 100xx)

SC 3

WG 24
Revision of
ISO 9001
8

ISO/TC176/SC2 Vision
SC2s products* are recognized and
respected worldwide, and used by
organizations as an integral component
of sustainable development

* ISO 9001, ISO 9004, and other guidance documents

(C) Nigel H Croft 2014 - All rights reserved

ISO/TC176/SC2 Mission

To develop, maintain and support a portfolio of

products that enable organizations to improve their
performance and to benefit from the implementation of
a robust quality management system.
To establish generic quality management system
requirements that provide the foundations to build
confidence in goods and services delivered
throughout the supply chain to organizations and
people worldwide.
To provide guidance and support, where needed, to
ensure the continued credibility of our products.
(C) Nigel H Croft 2014 - All rights reserved

10

What is a management system?

Formal definition.........
set of interrelated or
interacting elements of an
organization to establish
policies and objectives, and
processes to achieve those
objectives
In other words:
System should be results
focused
A documented system
NOT a system of
documents

Hardware
(equipment)

Software
(methods)

Interact within processes

(C) Nigel H Croft 2014 - All rights reserved

Humanware
(people)

11

Expected results from

management systems:

ISO 9001 Consistent, conforming

products
ISO 14001 Prevention of pollution
OHSAS 18001 Safe working conditions
ISO 50001 Efficient energy usage
ISO 22000 Safe food
etc.
(C) Nigel H Croft 2014 - All rights reserved

12

Cause and effect

Quality Management System
Committed top management

Effectiveness =
Ability to achieve
planned results

Calibrated equipment
Competent people
Monitoring & measurement Work instructions etc
Internal audits
Management review

Documented procedures
Etc etc etc

(C) Nigel H Croft 2014 - All rights reserved

CONSISTENT,
CONFORMING
PRODUCT

Efficiency =
Achieve planned results
with minimum resources
(Outputs / Inputs)

13

3 core concepts

Identify the processes needed to achieve the

planned results
Continually monitor the risks (Risk-based
thinking)

Understanding Cause and effect

Manage the processes and the system using

PDCA

(C) Nigel H Croft 2014 - All rights reserved

14

Act

Plan

How to improve
next time?

What to do?
(Objective)
How to do it?
(Procedure)

Check

Do

Did things happen

according to plan?

Do what was
planned

(C) Nigel H Croft 2014 - All rights reserved

15

Generic Process
How to carry out Process documented or not)
Extent of planning depends on RISK

INPUTS

Set of interrelated
activities

DESIRED
OUTPUTS
PRODUCT

CUSTOMER
(Internal or external)
Other Interested
Parties

Effect on Product conformance

Environmental Aspects / Impacts
Health and Safety Risks
Social implications
Energy usage
Etc etc

UNDESIRED OUTPUTS
(WASTE / POLLUTION etc.)

MONITOR/MEASURE
(C) Nigel H Croft 2014 - All rights reserved

16

Generic Process

How to carry out Process documented or not)

Extent of planning depends on RISK

INPUTS

Set of interrelated
activities

Effect on Product conformance

Environmental Aspects / Impacts
Health and Safety Risks
Social implications
Energy usage
Etc etc

DESIRED
OUTPUTS
PRODUCT

CUSTOMER
(Internal or external)
Other Interested
Parties

UNDESIRED OUTPUTS
(WASTE / POLLUTION etc)

MONITOR/MEASURE
(C) Nigel H Croft 2014 - All rights reserved

17

System of processes
A P
C D
Input E
PROCESS E

Input A
PROCESS A

AA PP
CC DD

Input B

AA PP
CC DD

Output A
Input C

Input D

PROCESS C

PROCESS B

Output
B

Ouput E

AA PP
CC DD

Output C

PROCESS D

Ouput D

AA PP
CC DD

AA PP
Output F
CC DD Internal Input F
Internal
PROCESS F
Customer

AA PP
CC DD

Customer

(C) Nigel H Croft 2014 - All rights reserved

Feedback
18

Harmonization of
management system
standards
(C) Nigel H Croft 2014 - All rights reserved

19

Positioning of some ISO (and other)

standards
Aerospace
I.T.
Service

ISO 27001

Supply chain
security

AS 9100

ISO 20000

Telecomm

TL 9000

Economic growth

Automotive
ISO/TS 16949

Environmental
(Reqts)
ISO 55000
ISO 14001

Environmental
(Guidelines)

Asset
Mgt.

Energy

ISO 50001

ISO 9001

ISO 22000

ISO 31000

ISO 9004

ISO 14064

ISO 20121

(OHSAS 18001)
Future ISO Std

Health &
Safety

(SA 8000)

Social resp.
Requirements

Social
responsibility
ISO 37001

Greenhouse
Gas

Quality
(Guidelines)

Sustainable
Purchasing

ISO 18617

Environmental
integrity

Food
safety

Risk
management

Sustainable
Development

ISO 14004

Quality
(Reqts)

ISO 28001

Information
Security

Anti- ISO 26000

bribery

Social resp.
Guidance

ISO 39001
ISO 14040

Life cycle

ISO 22301
(C) Nigel H Croft 2014 - All rights reserved
Sustainable
Road
events
safety

Business
continuity

20

Need for Alignment of

management system standards!

ISO Joint Technical Coordination Group

(JTCG):

Joint vision for management system standards

High level structure for all ISO management systems
standards
Identical sub-clause titles under the high level
structure
Generic core vocabulary for management system
standards

Aim is to make life easier for those who wish to

have a single management system
(C) Nigel H Croft 2014 - All rights reserved

21

ISO Directives Part 1:2012 Annex SL

Incorporates the recommendations of the JTCG

work
Defines the common structure and format for all
new ISO management system standards and
revisions to existing standards
Common text (approx 30% or more of each
standard will be identical text)
Significant impact on future revisions of ISO
9001 and ISO 14001
(C) Nigel H Croft 2014 - All rights reserved

22

Annex SL High Level Structure

1.
2.
3.
4.

Scope
Normative references
Terms and definitions
Context of the organization
Understanding the organization
and its context
Needs and expectations of
interested parties
Determining the scope
Management System

5. Leadership

Leadership and commitment

Policy
Roles, responsibility and
authority

6. Planning

Actions to address risks &

opportunities
Objectives and plans to achieve
them

7. Support

Resources
Competence
Awareness
Communication
Documented information

8. Operation

Operational planning and control

9. Performance evaluation

Monitoring, measurement,

analysis & evaluation

Internal audit
Management review

10. Improvement

Non conformity and corrective

action
Continual Improvement

(C) Nigel H Croft 2014 - All rights reserved

23

ISO 9001:2015 What

to expect

(C) Nigel H Croft 2014 - All rights reserved

24

The standards development process

VERIFICATION
PREPARATION

SPECIFICATIONS
NEEDS &
EXPECTATIONS

PROJECTS

WDs

CD

DIS

FDIS

VALIDATION
(C) Nigel H Croft 2014 - All rights reserved

25

High-Level Timing for ISO 9001:2015

Internal consensus
(ISO/TC176 experts)

Internal consensus
(within ISO)

First public airing

June 2012

Nov 2012

Jun 2013

Apr2014

Nov 2014

Jan 2015

Draft
Design Spec
& WD0*

Approved
Design Spec
& WD1*

CD* for
comment &
ballot

DIS* for
ballot

Draft
FDIS*

FDIS* for
ballot

Sept2015
Publication

Verification and
validation activities

SC2 Strategic Plan

Review of QMPs

User Survey

TG Future
Concept Papers

ISO Directives
Annex SL

Liaison with IAF & ISO/CASCO regarding transition

Interactions with SC1 (ISO 9000) on
terminology issues

* WD = Working Draft
CD = Committee Draft
DIS = Draft International Standard
FDIS = Final Draft International Standard

(C) Nigel H Croft 2014 - All rights reserved

26

Some key changes...........

Complete reformatting to align with Annex SL

Products and services instead of product
More emphasis on addressing risks & opportunities
Elimination of the term preventive action

the concept still remains, and is actually reinforced

throughout the standard (by addressing risk)

External provision of products and services instead

of purchasing includes outsourced processes
Elimination of specific requirements for

Quality Manual
Management representative
(C) Nigel H Croft 2014 - All rights reserved

27

Structure of ISO 9001:2015

PLAN
4 Context of
organization

5 Leadership

DO

6 Planning

7 Support

Understanding
of the
organization
and its context

Leadership
and
commitment

Actions to
address risk
and
opportunity

Needs &
Expectations of
interested
parties

Quality policy

Roles,
responsibilities
and
authorities

Scope of the
QMS

CHECK
9 Performance
evaluation

8 Operation

ACT
10 Improvement

Resources

Operation
planning and
control

Monitoring,
measurement,
analysis and
evaluation

Nonconformity
and corrective
action

Quality
objectives

Competence

Determination of
requirements for
products/
services

Internal audit

Continual
improvement

Planning of
changes

Awareness

Design and
development

Management
review

QMS and its

Processes

Communication

Documented
information

Control of
externally provided
products and
services
Production &
service
provision
Release of
products and
services

(Slide Courtesy of Alan Daniels; Boeing)

Control of
Nonconforming
process outputs,
products and
services

(C) Nigel H Croft 2014 - All rights reserved

28

4.1 , 4.2, 4.3

Establish context,
define relevant
interested parties &
scope of QMS

10 Continual improvement

5 Leadership
Customer focus
Quality Policy
Roles &
responsibilities

4.4 QMS - General

&
Process Approach
6 Planning
Risks/Opportuniti
es
Objectives
Change planning

Customers &
other relevant
interested parties

Requirements

Inputs

9 Performance evaluation
Monitoring,
measurement,
Customer Sat
Data analysis
Internal Audit
Management review

Outputs

8 Operations

Resources
7 Support processes
Infrastructure
Process environment
Monitoring/measuring devices

Customer
Satisfaction

Products &
services

Knowledge management
Competence
Awareness
Communication
Document control

(C) Nigel H Croft 2014 - All rights reserved

29

Implementation guidance

Work is underway to develop generic

implementation guidance for ISO 9001:2015

to be numbered as ISO/TS 9002

will incorporate previous guidance for small
businesses

Aim is to have this available at the same time

ISO 9001:2015 is published

(C) Nigel H Croft 2014 - All rights reserved

30

Transition to ISO 9001:2015

Scheduled publication date September 2015

ISO/TC176, ISO/CASCO and IAF have
approved a 3-year transition period
All organizations are strongly encouraged to
start the transition now the DIS is published
(mid-2014)

Aim is to avoid peak of audits to the new standard

near end of transition period
Avoid overload of CB resources
(C) Nigel H Croft 2014 - All rights reserved

31

Conclusions

ISO is aligning its portfolio of management system

standards

ISO 9001 is undergoing a major revision

Aim is to facilitate integration

Now at DIS stage scheduled publication Sept 2015
Significant changes in structure and clause sequence
Process Approach + PDCA + Risk-based thinking
Some new requirements

Stay tuned to whats happening via www.iso.org

Start preparing for the transition NOW!
(C) Nigel H Croft 2014 - All rights reserved

32

THANK YOU!
[email protected]

(C) Nigel H Croft 2014 - All rights reserved

33

Some key changes

(Based on the Draft
International Standard)

(C) Nigel H Croft 2014 - All rights reserved

34

4.1 Understanding the

organization and its context
NEW

Organization shall:

determine external and internal issues that are

relevant to purpose and strategic direction and
that affect ability to achieve the intended result(s)
of QMS.
monitor and review the information about these
external and internal issues.

(C) Nigel H Croft 2014 - All rights reserved

35

Context of the organization

External context includes*

cultural, social, political, legal, regulatory, financial, technological,

economic, natural and competitive environment, whether
international, national, regional or local;
relationships with, and perceptions/values of external stakeholders

Internal context includes*

corporate culture;
governance, organizational structure, roles and accountabilities;
policies, objectives, and strategies
resources (capital, time, people, processes, systems technologies);
information systems, information flows and decision-making
processes (both formal and informal)
* (taken from ISO 31000)
(C) Nigel H Croft 2014 - All rights reserved

36

NEW

4.2 Understanding the needs and

expectations of interested parties

The organization shall

determine the interested parties that are relevant to the QMS,

determine the related requirements of these interested parties
that are relevant to the QMS
monitor and review the information about these interested parties
and their relevant requirements

ISO 9001:2015 focuses attention on those interested

parties that can impact the organizations ability
consistently provide conforming products and services
(C) Nigel H Croft 2014 - All rights reserved

37

4.3 Determining the scope of

the QMS

Nothing
really new

The organization shall determine the boundaries and applicability of

the QMS to establish its scope.
Must consider
the external and internal issues referred to in 4.1,
the requirements referred to in 4.2
products and services provided.
ISO/DIS 9001:2015 includes comments that:
All requirements are applicable
If a requirement cannot be applied, it must

not affect the ability to provide conforming product

be justified
(C) Nigel H Croft 2014 - All rights reserved

38

4.4 Quality management system

and its processes
establish, implement, maintain and continually improve the
Nothing
QMS, including the processes needed and their
really new
interactions, in accordance with the requirements of this
International Standard.
(This is key to maintaining the process approach,
which will now be embedded in ALL ISO management
system standards)
Plus a Beefed-up version of current clause 4.1 of ISO
9001:2008 , with new requirements as follows: NEW
(C) Nigel H Croft 2014 - All rights reserved

39

4.4 QMS and its processes

(contd)
Organizations shall determine:
inputs required and outputs expected from the QMS
processes;
criteria, methods, including measurements and
related performance indicators needed to ensure the
effective operation and control;
assignment of the responsibilities and authorities for
these processes;
risks and opportunities and plan and implement
NEW
appropriate actions to address them;

(C) Nigel H Croft 2014 - All rights reserved

NEW

NEW

NEW

40

5.1 Leadership and commitment

Top management shall demonstrate leadership and commitment with
respect to the quality management system by
NEW

taking

accountability of the effectiveness of the QMS;

NEW
ensuring policy and objectives are compatible with strategic direction
NEW
ensuring the quality policy is communicated, understood and applied
ensuring integration of the QMS requirements into business processes
NEW
promoting awareness of the process approach;
NEW
communicating importance of effective quality management and of conforming to
NEW
the QMS requirements;
NEW
ensuring that the system achieves its intended results
engaging, directing and supporting persons to contribute to the effectiveness
NEW
of the QMS;
NEW
promoting continual improvement
supporting other relevant management roles to demonstrate their
NEW
leadership as it applies to their areas of responsibility.
(C) Nigel H Croft 2014 - All rights reserved

41

5.1 Leadership and commitment

Top management is also required to ensure that:
customer requirements and applicable statutory / regulatory
requirements are determined and met;
the risks and opportunities that can affect conformity of products and
services and the ability to enhance customer satisfaction are determined
NEW
and addressed;
the focus on consistently providing products and services that
meet customer and applicable statutory and regulatory requirements
NEW
is maintained;
the focus on enhancing customer satisfaction is maintained.

(C) Nigel H Croft 2014 - All rights reserved

42

5.2 Quality Policy

Top management shall establish a quality policy that:
Nothing
Is appropriate to the purpose of the organization,
really new
provides a framework for setting quality objectives;
includes a commitment to satisfy applicable requirements, and
includes a commitment to continual improvement of the quality
management system
The quality policy shall
be available as documented information
be communicated within the organization
be available to interested parties, as appropriate.

(C) Nigel H Croft 2014 - All rights reserved

NEW

43

5.3 Organizational roles,

responsibilities and authorities
Top management shall assign the responsibility and
authority for..
NEW
ensuring that the processes are delivering their intended
outputs;
reporting on the performance of the quality management
system, on opportunities for improvement and on the
need for change or innovation, and especially for
reporting to top management;
This is typically what we would expect
from the Management Representative,
though this name is no longer used
(C) Nigel H Croft 2014 - All rights reserved

44

6.1 Actions to address risks &

opportunities
NEW

determine the risks and opportunities that need to be addressed to

give assurance that the QMS can achieve its intended result(s)
prevent or reduce undesired effects
achieve continual improvement.
Plan:
a) actions to address these risks and opportunities, and
b) how to
integrate and implement these actions into the QMS processes
evaluate the effectiveness of these actions.
Actions taken to address risks and opportunities shall be proportionate to the
potential impact on the conformity of products and services.
NOTE Options can include: avoiding risk, taking risk in order to pursue an
opportunity, eliminating the risk source, changing the likelihood or
consequences, sharing the risk, or retaining risk by informed decision.
(C) Nigel H Croft 2014 - All rights reserved

45

6.2 Quality objectives and

planning to achieve them
The organization shall establish quality objectives at relevant functions,
levels and processes.
NEW
The quality objectives shall
be consistent with the quality policy
be measurable
Nothing
really new
take into account applicable requirements
be relevant to conformity of products and services and the
enhancement of customer satisfaction;
be monitored
be communicated, and
be updated as appropriate.
(C) Nigel H Croft 2014 - All rights reserved

46

6.2 Quality objectives and

planning to achieve them (contd..)
When planning how to achieve its quality
objectives, the organization shall determine

what will be done

what resources will be required
who will be responsible
when it will be completed
how the results will be evaluated.

(C) Nigel H Croft 2014 - All rights reserved

47

6.3 Planning of changes

Where there is a need for change to the QMS
this must be done in a planned and systematic
manner, considering:
the purpose of the change and any potential
consequences; NEW
the integrity of the QMS
the availability of resources;
allocation or reallocation of responsibilities
and authorities.
(C) Nigel H Croft 2014 - All rights reserved

48

7 Support Processes

Resources
Competence
Awareness
Communication
Documented information

(C) Nigel H Croft 2014 - All rights reserved

49

7.1 Resources

The organization shall determine and provide the

resources needed for the establishment,
implementation, maintenance and continual
improvement of the QMS.
ISO 9001:2015 will include additional requirements:

Nothing
People
really new
Infrastructure
Process environment
Monitoring & measuring resources
Organizational knowledge NEW
(C) Nigel H Croft 2014 - All rights reserved

Previously
Work environment
Nothing
really new

50

7.1.6 Organizational Knowledge

NEW

..When addressing changing needs and trends, the

organization shall consider its current knowledge and
determine how to acquire or access the necessary
additional knowledge:
can include information such as intellectual property and
lessons learned
can consider:

internal sources (e.g. learning from failures and successful projects,

capturing undocumented knowledge and experience of topical experts
within the organization);
external sources (e.g. standards, academia, conferences, gathering
knowledge with customers or providers).

(Remember Deming - There is no substitute for profound knowledge of the business!)

(C) Nigel H Croft 2014 - All rights reserved

51

7.2 Competence

Nothing
really new

Attention!

The organization shall

determine the necessary competence of person(s) doing work under
its control that affects its quality performance,
ensure that these persons are competent on the basis of appropriate
education, training, or experience;
where applicable, take actions to acquire the necessary competence,
and evaluate the effectiveness of the actions taken
retain appropriate documented information as evidence of competence.
NOTE Applicable actions may include, for example: the provision of
training to, the mentoring of, or the re-assignment of currently
employed persons; or the hiring or contracting of competent
persons.

(C) Nigel H Croft 2014 - All rights reserved

52

7.3 Awareness
Persons doing work under the organizations control
shall be aware of:
Nothing
really new
the quality policy and relevant objectives
their contribution to the effectiveness of the QMS,
including the benefits of improved quality performance
the implications of not conforming with the QMS
NEW
requirements.

(C) Nigel H Croft 2014 - All rights reserved

53

7.4 Communication
The organization shall determine the internal and external
communications relevant to the QMS including
NEW
on what it will communicate
when to communicate
with whom to communicate
how to communicate

(C) Nigel H Croft 2014 - All rights reserved

54

7.5 Documented information

Nothing
really new

Previously known as documents and records

Documents need to be maintained as documented
information
Records need to be retained as documented
information

(C) Nigel H Croft 2014 - All rights reserved

55

8 Operation

Operational planning and control

Determination of customer requirements
Design and development of products and services
Control of external provision of products and services
(Purchasing and outsourcing addressed together)
Realization and provision of products and services
Release of products and services
Control of nonconforming products and services

(C) Nigel H Croft 2014 - All rights reserved

56

8.1 Operational planning

and control
Plan, implement and control the processes needed to meet
requirements for the provision of products and services, and to
implement the actions determined in 6.1 by:
determining requirements for the products and services
establishing criteria for the processes and acceptance criteria
determining the resources needed
implementing the control of processes
retaining documented information

NEW

NEW

Control planned changes and review the consequences of unintended

changes, taking action to mitigate any adverse effects, as necessary
Ensure that outsourced processes are controlled.
(C) Nigel H Croft 2014 - All rights reserved

57

8.2 Determination of requirements

for products and services
Nothing
really new

8.2.1
Customer communication
Establish the processes for communicating with customers in relation to:
information relating to products and services;
enquiries, contracts or order handling, including changes;
obtaining customer views and perceptions, including customer complaints;
handling or treatment of customer property, if applicable;
specific requirements for contingency actions, when relevant
NEW
8.2.2 Determination of requirements.
Process to determine the requirements for the products and services to be
offered to potential customers.
NEW
Ensure the organization has the ability to meet the defined requirements
and substantiate the claims for the products and services it offers.
(C) Nigel H Croft 2014 - All rights reserved

58

8.3 Design and development of

products and services
Where the detailed requirements of the organizations products
and services are not already established or not defined by the
NEW
customer or by other interested parties, such that they are
adequate for subsequent production or service provision, the
organization shall establish, implement and maintain a design and
development process.
The organization can also apply the requirements given in 8.5 to the
development of processes for production and services provision
For services, design and development planning can address the
whole service delivery process. The organization can therefore choose
NEW
to consider the requirements of clauses 8.3 and 8.5 together.
(Remainder of design & development clause has been maintained and/or
simplified compared to ISO 9001:2008)
(C) Nigel H Croft 2014 - All rights reserved

59

Previously
Purchasing

8.4 Control of externally

provided products and services

Ensure that externally provided processes, products, and services

conform to specified requirements.
Apply the specified requirements for the control of externally provided
products and services when:
products

and services are provided by external providers for incorporation into

the organizations own products and services;
products and services are provided directly to the customer(s) by
NEW
external providers on behalf of the organization;
a process or part of a process is provided by an external provider as a result
of a decision by the organization to outsource a process or function.
Type and extent of controls to be applied depends on:

potential impact of the externally provided processes, products and services

perceived effectiveness of controls applied by external provider.
NEW

(C) Nigel H Croft 2014 - All rights reserved

60

8.5 Production and service

provision
Implement controlled conditions for production and service provision,
including delivery and post-delivery activities. This can include:
NEW
definition of the product and service characteristics (documented);
activities to be performed and results to be achieved (documented);
monitoring and measurement activities
use and control of suitable infrastructure and process environment;
availability and use of suitable monitoring and measuring resources;
competence and, where applicable, required qualification of persons;
NEW
validation, and periodic revalidation, of special processes;
formal release of products and services, delivery and post-delivery
activities.
NEW

(C) Nigel H Croft 2014 - All rights reserved

61

8.5 Production and service

provision (continued)
Nothing
really new

Identification and traceability

NEW
Property belonging to customers or external providers
Nothing
Preservation really new
Post-delivery activities Consider: NEW

Previously
Customer
property

risks associated with the products and services;

nature, use and intended lifetime
customer feedback;
statutory and regulatory requirements.

Control of changes

NEW

review and control unplanned changes essential for production or

service provision to ensure continuing conformity
(C) Nigel H Croft 2014 - All rights reserved

62

8 Operation (continued)
Nothing
really new

Previously
Clause 8.2.4 of
ISO 9001:2008

8.6 Release of products and services

NEW
8.7 Control of nonconforming process outputs,
products and services

Now requires actions taken to be documented

includes any concessions obtained

details of person or authority that made the decision regarding
dealing with the nonconformity.
NEW

(C) Nigel H Croft 2014 - All rights reserved

63

9 Performance evaluation

Monitoring, measurement, analysis and evaluation

General
Nothing
really new
Customer satisfaction
Analysis and evaluation of data
Nothing
really new

Internal Audit
Management review

(C) Nigel H Croft 2014 - All rights reserved

64

9.1 Monitoring, measurement,

analysis and evaluation

Determine:

what needs to be monitored and measured

methods for monitoring, measurement, analysis and
evaluation, as applicable, to ensure valid results
when the monitoring and measuring shall be
performed
when the results from monitoring and measurement
shall be analysed and evaluated.

Retain appropriate documented information.

Evaluate the quality performance and the
effectiveness of the QMS
(C) Nigel H Croft 2014 - All rights reserved

65

9.3 Management review

Now includes requirements to consider:
changes in external and internal issues that are
relevant to the QMS and strategic direction; NEW
information on the quality performance,
including trends and indicators for: NEW

monitoring and measurement results;

issues concerning external providers and other
relevant interested parties;
adequacy of resources
effectiveness of actions taken to address risks and
opportunities
(C) Nigel H Croft 2014 - All rights reserved

66

10 Improvement

General
Nonconformity and corrective action
Continual improvement

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67

10.1 General

Implement actions to meet customer requirements

and enhance customer satisfaction, by:

improving processes to prevent nonconformities;

improving products and services to meet known and
NEW
predicted requirements;
improving quality management system results.

NOTE: Improvement includes more than just

continual improvement (Kaizen)
NEW

May also include breakthrough improvements,

innovation, transformation etc.
(C) Nigel H Croft 2014 - All rights reserved

68

10.2 Nonconformity and

corrective action
When a nonconformity occurs, the organization shall:
a) react to the nonconformity, and as applicable

take action to control and correct it, and

deal with the consequences;

NEW

b) evaluate the need for action to eliminate the causes of the

nonconformity, in order that it does not recur or occur elsewhere, by

reviewing the nonconformity

determining the causes of the nonconformity, and
determining if similar nonconformities exist, or could potentially occur;

NEW

c) implement any action needed;

d) review the effectiveness of any corrective action taken; and
e) make changes to the quality management system, if necessary.

(C) Nigel H Croft 2014 - All rights reserved

69

10.3 Continual improvement

Consider outputs of analysis and evaluation,

and outputs from management review, to
identify areas of underperformance or
NEW
opportunities for improvement.
Select and utilise applicable tools and
methodologies for investigation of the
NEW
causes of underperformance and for
supporting continual improvement.
(C) Nigel H Croft 2014 - All rights reserved

70

Contact us today
Dr Nigel H Croft
Chair, ISO/TC176/SC2 (Quality Systems)
E-Mail: [email protected]

For all Inquiries:

[email protected]