PRESENTATION

PRESENTATION ON :-

IRIS : International Railway Industry Standard

ISO/TS 22163:2017

PRESENTATION BY :
Anoop Tripathi
Sakhi Management Consulting Pvt. Ltd.
FF-121, Beta Tower, Secotr-3, Vasundhra-
201012
Ph: +91-120-4132807
E: [email protected]

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 IRIS

IRIS : INTERNATIONAL RAILWAY

INDUSTRIES STANDARD

A Business Management Standard for

Railway Industries

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 AGENDA
⮚What is IRIS
⮚IRIS Background
⮚Objective /AIM
⮚Unique to IRIS
⮚Standard and its Requirements
⮚Revision History
⮚Certification Process
⮚IRIS Scoring Methodology
⮚Types of Questions
⮚Benefits
⮚Registration on IRIS
⮚Readiness of Audit
⮚Additional Requirements
⮚Benefits
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 WHAT IS IRIS
❖An international standards with the
business management system requirements
for the rail sector

❖Initiative led by : UNIFE (Union des Industries

Ferroviaires Européennes)
Union of the European Railway Industries (UNIF
E)
:

❖Four key players:

❑Bombardier,
❑Siemens,
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❑Alstom and [email protected]
IRIS COMMITTEE MEMBERS

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 Why IRIS

⮚ Quality problems in Rolling Stock

⮚ Multiple Audits

⮚ Multiple requirements

⮚ High cost in supply chain

⮚ Supplier Assessment /Selection problems

Operators requested rationalization and some

reliable tool.
⮚ It lead to formation of standard specific to rail
industry
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 Aim of IRIS

• To prepare railway specific standard

• Common global system

•One harmonized evaluation process to be

performed by approved certification
bodies.

•A web-based IRIS Portal (common

database) and Audit-Tool (software

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 Objective of IRIS
To Improve :

•Quality

•Safety

•Reliability

•Prevent defect

•Reduce cost

Throughout the supply chain

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 Content of IRIS

•Business management system Requirements

•A questionnaire derived from standard

•An evaluation process with assessment

guidelines

•A web based IRIS portal( Database) and audit

tools(Software tools)

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 Applicability

It can be applied to:

•Manufacturer of rail mounted vehicles

•Direct ancillary industries

•Indirect ancillary industries

of
•System construction part and Individual
components

•Operator
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Standard development body
✔ The development of the standard is transparent
and involve all market participants via UNIFE.

✔ The standard is owned and managed by UNIFE

(ensure independency).

✔ Audit results are traced confidentially and

published only with allowance of the Audit Client.

✔ Rules for protection of data privacy will be

followed.

✔ Approval of certification bodies is fair and

transparent.
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Standard requirements

⮚Rev 01 Nov 2007

⮚Rev 02 2009

⮚ISO /TS 22163:2017

⮚Compatible to ISO 9001:2015 and ISO 9004:2009

⮚Stronger maturity level

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Standard requirements
Is based on the ISO 9001 Structure.

􀂄 IRIS adds a layer, which contains railway specific

requirements for the Business Management System,
e.g.

􀂋 Project Management,

􀂋 Design, etc…

􀂄 IRIS contains:

􀂋 Mandatory requirements with «Shall» wording.

􀂋 Optional requirements with «Should» wording.
􀂄 Some requirementswwww.isoconsultants.in,
are “KnockOut” criteria.Rev
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Standard requirements
0. Foreword 5. Leadership
1. Scope 5.1 Leadership and commitment
2. Normative Reference 5.2 Policy
3. Terms and Definitions 5.3 Organization roles and
4. Context of Organization responsibilities
4.1 Understanding the 6. Planning
organization context 6.1 Action to address risk and
4.2 Understanding the need and opportunities
expectation of interested parties 6.2 Quality objective and
4.3 Determining the scope of planning to achieve them
Quality Management system 6.3 Planning of change
4.4 Quality management system 6.4 Business Planning
and its process

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 Standard requirements
7. Support 8.6 Release of products and services
7.1 Recourses 8.7 Control of nonconforming outputs
7.2 Competence 8.8 RAMS / LCC
7.3 Awareness 8.9 First article inspection
7.4 Communication 8.10 Obsolescence management
7.5 Documented information 8.11 Innovation management
8. Operations 9. Performance evaluation.
8.1 Operational Planning and control 9.1 Monitoring, measurement, analysis
8.2 Requirements for product & and evaluation
Services 9.2 Internal audit
8.3 Design & Development of 9.3 Management review.
Production Services 9.4 Process reviews
8.4 control of externally provided 10. Improvement
processes, products and services 10.1 General
8.5 Production and service provision 10.2 Nonconformity and corrective
action
10.3 Continual improvement
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Schematic representation of the
elements of a single process

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PDCA CYCLE

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 SCOPE
1 Scope

This International Standard specifies requirements for a

quality management system when an organization:
a) Needs to demonstrate its ability to consistently provide
products and services that meet customer and applicable
statutory and regulatory requirements, and

b) Aims to enhance customer satisfaction through the effective

application of the system, including processes for improvement
of the system and the assurance of conformity to customer and
applicable statutory and regulatory requirements.

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 Normative References
2. Normative references

The following documents, in whole or in part, are

normatively referenced in this document and are
indispensable for its application. For dated references, only
the edition cited applies. For undated references, the latest
edition of the referenced document (including any
amendments) applies.

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 Terms and Definitions
3 Terms and definitions

For the purposes of this document, the terms and

definitions given in ISO 9000:2015 apply.
3.1 Terms and definitions for the rail sector
3.1.1 application software
3.1.2 availability
3.1.3 commissioning
3.1.4 component
3.1.5 configuration audit
3.1.6 configuration baseline
3.1.7 configuration status accounting
3.1.8 consignment stock
3.1.9 critical critically
3.1.10 deferred work wwww.isoconsultants.in,
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 Terms and Definitions
3.1.11 deliverables
3.1.12 first article inspection
3.1.13 Failure Reporting Analysis and Corrective Action
System
3.1.14 functional requirement
3.1.15 gate criteria
3.1.16 handover
3.1.17 installation
3.1.18 integration maturity
3.1.19 integration requirements
3.1.20 key performance indicator
3.1.21 life cycle costing
3.1.22 maintainability
3.1.23 maintenance
3.1.24 manufacturing
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 Terms and Definitions
3.1.25 multidisciplinary approach
3.1.26 non-functional requirements
3.1.27 operational maturity
3.1.28 product configuration information
3.1.29 product life cycle
3.1.30 product equipment
3.1.31 project core team
3.1.32 project management
3.1.33 quality assurance methods
3.1.34 quality deficiency cost
3.1.35 reliability
3.1.36 safety
3.1.37 safety case
3.1.38 safety integrity level
3.1.39 safety-related
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 Terms and Definitions
3.1.40 site
3.1.41 supply chain
3.1.42 transfer

3.2 Abbreviations

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CONTEXT OF THE ORGANIZATION
4. Context of the organization

4.1 Understanding the organization and its context

The organization shall determine external and internal
issues that are relevant to its purpose and its strategic
direction and that affect its ability to achieve the intended
result(s) of its quality management system.

4.2 Understanding the needs and expectations of

interested parties
Due to their effect or potential effect on the organization’s
ability to consistently provide products and services that
meet customer and applicable statutory and regulatory
requirements, the organization shall determine:

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CONTEXT OF THE ORGANIZATION
4.3 Determining the scope of the quality
management system

The organization shall determine the boundaries and

applicability of the quality management system to establish its
scope.
When determining this scope, the organization shall consider:

1. the external and internal issues referred to in 4.1;

2. the requirements of relevant interested parties referred to in

4.2;

3. the products and services of the organization.

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CONTEXT OF THE ORGANIZATION
4.4 Quality management system and its
processes
4.4.1 The organization shall establish, implement,
maintain and continually improve a quality
management system, including the processes needed
and their interactions, in accordance with the
requirements of this International Standard.
4.4.2 To the extent necessary, the organization shall:
a. Maintain documented information to support the
operation of its processes;

b. retain documented information to have confidence

that the processes are being carried out as planned.
4.4.3 Quality management system and its
processes
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 LEADERSHIP
5 Leadership

5.1 Leadership and commitment

5.1.1 General
5.1.2 Customer focus
5.2 Policy
5.2.1 Establishing the quality policy
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.
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 LEADERSHIP
5.2.2 Communicating the quality policy
a) be available and be maintained as documented
information;

b) be communicated, understood and applied within

the organization;

c) be available to relevant interested parties, as

appropriate.

5.2.3 Quality policy

5.2.4 Safety policy

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 LEADERSHIP
5.3 Organizational roles, responsibilities
and authorities
Top management shall ensure that the
responsibilities and authorities for relevant roles
are assigned, communicated and understood
within the organization.

5.3.1 Organizational roles, responsibilities

and authorities
5.3.2 Responsibilities and authorities of
process owners

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 PLANNING
6 Planning

6.1 Actions to address risks and opportunities

6.2 Quality objectives and planning to achieve them

6.3 Planning of changes

6.4 Business planning

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 SUPPORT
7 Support

7.1 Resources

7.1.1 General

7.1.2 People

7.1.3 Infrastructure

7.1.4 Environment for the operation of processes

7.1.5 Monitoring and measuring resources

7.1.6 Organizational knowledge

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 SUPPORT
7.2 Competence

7.3 Awareness

7.4 Communication

7.5 Documented information

7.5.1 General
7.5.2 Creating and updating
7.5.3 Control of documented information

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 OPERATION
8 Operation

8.1 Operational planning and control

8.1.1 Planning for the outsourcing or transfer of
processes
8.1.2 Tender management
8.1.3 Project management
8.1.4 Configuration management
8.1.5 Change management

8.2 Requirements for products and services

8.2.1 Customer communication
8.2.2 Determining the requirements related to
products and services
8.2.3 Review of requirements related to products
and services
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 OPERATION
8.2.4 Changes to requirements for products and
services
8.2.5 Requirements for products and services

8.3 Design and development of products and

services
8.3.1 General
8.3.2 Design and development planning
8.3.3 Design and development inputs
8.3.4 Design and development controls
8.3.5 Design and development outputs
8.3.6 Design and development changes

8.4 Control of externally provided processes,

products and services
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 OPERATION
8.4.1 General
8.4.2 Type and extent of control
8.4.3 Information for external providers
8.4.4 Supply chain management

8.5 Production and service provision

8.5.1 Control of production and service provision
8.5.2 Identification and traceability
8.5.3 Property belonging to customers or external
providers
8.5.4 Preservation
8.5.5 Post-delivery activities
8.5.6 Control of changes

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 OPERATION
8.5.7 Production scheduling

8.6 Release of products and services

8.6.1 Release of products and services

8.7 Control of nonconforming outputs

8.8 RAMS / LCC

8.9 First article inspection

8.10 Obsolescence management

8.11 Innovation management

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PERFORMANCE EVALUATION
9 Performance evaluation

9.1 Monitoring, measurement, analysis and

evaluation
9.1.1 General
9.1.2 Customer satisfaction
9.1.3 Analysis and evaluation

9.2 Internal audit

9.3 Management review
9.4 Process reviews

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 IMPROVEMENT
10 Improvement

10.1 General
10.2 Nonconformity and corrective action
10.3 Continual improvement

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IRIS SCORING METHODOLOGY
Audit results are scored, its not a fail/pass system
⮚Questionnaire has 253 questions :

⮚111 questions relative to ISO Requirements

⮚ 142 questions relative to IRIS Requirements

⮚ 10 K.O. questions, not scored, fulfillment

mandatory

⮚ 32 Closed questions

⮚ Yes/No question

⮚ 211 Open questions

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CERTIFICATION PROCESS

⮚Preparation and request for IRIS certification

⮚Evaluation Process
⮚Readiness review
⮚Certification audit
✔Scoring Methodologies
✔Scoring principles
✔Knock out questions
✔Open questions
✔Closed questions
✔Corrective or improvement program
.

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 BENEFITS OF IRIS
⮚Improved product quality & supply
chain efficiency.

⮚Reduction of effort and cost.

⮚ More accurate and reliable

Information about suppliers to the
railway industry.

⮚ Fair evaluation by independent

certification bodies.
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Why Registration On IRIS PORTAL
❖To get details about IRIS

❖To purchase audit tools

❖Choose CB

❖Be ready for IRIS audit

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 Readiness Audit
✔Business Management Manual
✔Quality Policy
✔Org chart
✔Mandatory procedures
✔Mandatory processes
✔KPI
✔Preachment kinked to mandatory requirements
✔Site specific conditions
✔Scope verification
✔Resource allocation
✔Audit planning
✔Site location
✔If knock out requirements are not meted than re audit is
done

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 Additional Requirements

✔ The development of the standard is transparent

and involve all market participants via UNIFE.
✔ The standard is owned and managed by UNIFE
(ensure independency).
✔ Audit results are traced confidentially and
published only with allowance of the Audit Client.
✔ Rules for protection of data privacy will be
followed.
✔ Approval of certification bodies is fair and
transparent.

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 Additional Requirements
Knowledge management Communication management
􀂄 Management of multi sites 􀂄 Risk and opportunity
projects management
􀂄 Requirements management 􀂄 Change management
􀂄 Competences, awareness 􀂄 First article inspection
and 􀂄 Configuration management
training 􀂄 Outsourcing (Make or Buy)
􀂄 Infrastructure management 􀂄 Supply chain management
􀂄 Tender management 􀂄 Commissioning / Customer
􀂄 Integration management service
􀂄 Scope management 􀂄 RAMS / LCC
􀂄 Time management 􀂄 Control of nonconforming
􀂄 Cost management processes

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Mandatory processes for evaluation

5 mandatory process for performance evaluation

a) Project management 8.1.3

b) requirement management 8.2

c) EPPS/purchase 8.4

d) design and development 8.3

e) production and service provision 8.5

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KO-Knockout process
Clause
Sl No Clause

1 6.1.3.1 Risk management process

Competence management activity
2 7.2.1.3
Project Management
3 8.1.3
4 8.1.4 Configuration Management

5 8.1.5 Change Management

requirements of product and services

supplimentals
6 8.2.5.1
Externally provided processes,
product & Service
7 8.4.1.1.2
Special process
8 8.5.1.2.1
9 8.8.1 RAM/LCC
10 8.9.1 FAI
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 Scoring Methods

Sl Level Score Conditions

No
1 Optimize 4 The requirements is exceeded
d and continuously improved

2 Qualified 3 The requirements is exceeded

3 Defined 2 The requirements is met

4 Poor 1 The requirements partially met

5 Insuffecis 0 The requirements not met

nt

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Closed questions:
Scoring Methods

1 Yes 2 The requirements is

met

2 No 0 The requirements not

met

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 Annex-01 of standard

Certification Body may only carry out audits

in the areas of the particular railway
equipment in which its Auditors are approved.
1 Car body
2 Car body fittings
3 Guidance (Bogies and running gear)
4 Power System
5 Propulsion
6 Auxiliary systems
7 Braking System
8 Interiors
9 On board vehicle control
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 Additional Requirements

10 Passenger Information Systems

11 Communication systems
12 Cabling and Cabinets
13 Door System
14 HVAC
15 Tilt System
16 Lighting
17 Coupler

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 Benefits

⮚One demanding International recognized Standard

for the Railway Industry.

⮚Reduction of non conformity costs due to suppliers

deficiencies

IRIS will support the manufacturers and the

suppliers in improving their process quality
continuously.

⮚Reduction of non conformity costs due to suppliers

deficiencies

⮚Increase the number of approved suppliers

=> whilst stopping of audits performed by internal
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 Benefits
Qualification Method

0: Poor
1: Insufficient
2: Defined- two type- open and closed yes/no if yes-2, if No-0,
3. Qualified
4: Optimized

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 IRIS benefits

⮚Reduction of efforts in terms of time and expenses

for approving suppliers
=> Thus enhance focus on supplier performance
and on specific product requirements.

⮚Reduction of costs for maintaining the “approved

supplier lists” in ERP systems.
=> They will become obsolete. In future, the data will
be maintained on one common IRIS web database.

⮚Improvement of Quality of Equipments & Rolling

Stock

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