Iris Short FTQM

Fouryes TQM Consultants
IRIS
I t
International
ti l Railway
R il Industry
I d t Standard
St d d
Rev. 02 : 2009
AG-3, Second Floor, Shanthi Colony, Anna Nagar, Chennai-600040, India

Ph.: +91-04442127102, 98414 31336 Email: ftqm@fouryestqm.in, Web: www.fouryestqm.in
Content
About ISO 9001
IRIS History
Quality
y Management
g Principles
p
Process Approach
IRIS Requirements including ISO 9001 Requirements
Assessment Methodology
Copyright 2014. Fouryes TQM Consultants. All rights reserved

About ISO 9001
ISO International Organization for Standardization
ISO/TC 176 Technical Committee is responsible for
Framing and Revising the Standard.
Publications
bli i : 1987, 1994, 2000 and
d 2008
Applicable to all Organizations

About ISO 9001
ISO 9000 Fundamentals of QMS and Specifies

p the
terminology for QMS
ISO 9001 Requirements for a QMS
ISO 9004 Provides guidelines that consider

both the effectiveness & efficiency of the QMS
ISO 19011 Guidance on auditingg Q

QMS & EMS

IRIS History
1999: During the General Assembly in Hong Kong, Operators have
complained about poor product quality and bad reliability off some
Rolling Stock and requested to improve the quality of the Supply
Chain.
Chain
2000: In Germany most of the railway equipment manufacturers

complained about the number of different requirements and audits
from system integrators and operators and requested rationalization.
2000 2004: two different Working Groups set by Alstom and

Siemens-Bombardier worked independently to find solutions.
April 2004: Alstom, Bombardier and Siemens started cooperation.

IRIS History
2004: birth of the RIC (Railway Industry Cooperation) with the objective
to develop a system to increase the quality off processes and products
in the railway supply chain. As soon as a draft of the standard was
developed the name was changed into IRIS ( nternational I Railway

Industry Standard) in early 2005.
2005
May 2005: UNIFE (Association of the European Rail Industry) General

Assembly accepted the integration of IRIS Group.
July 2005: Constitution of IRIS Group with participation of system

integrators and equipment manufacturers.
IRIS History
Sept-Oct. 2005: Validation phase of the IRIS System (pilot audits).
March 2006: The IRIS Management Centre was fully staffed and the
system was fine tuned according to the feedbacks from the validation
phase.
May 2006: IRIS Rev00 was officially launched in Geneva.
November 2007: IRIS Rev01 was launched on the market (incl.

Signalling).
g g)
June 2009: IRIS Rev02 was launched on the market

IRIS History

Objective
IRIS aims at developing and implementing a common global system
for the evaluation of Business Management Systems specific to the
railway industry, comprising:
an international standard based on the principles of ISO 9001

for the business management systems requirements in the railway
industry
an evaluation process with an assessment guideline to be

performed by approved certification bodies,
a web-based IRIS Portal (database) and Audit-Tool

What makes the difference to ISO?
General requirements
Improvement100 Documentation requirements
Analysis of data Knowledge management
Control of nonconforming processes 90 Management of Multisite projects
Control of nonconforming
gpproducts 80 Management
g commitment
70
Monitoring and measurement Customer focus
60
Measurement, analysis 50 Quality policy
and improvement
40
Obsolescence Management 30 Planning
20 Responsibility, authority
RAMS / LCC
10 and communication
Commissioning / 0
Management review
customer service
First article inspection Provision of resources
Configuration management Human resources
Project management Infrastructure

Control of monitoring
Contingency plan
and measuring devices
Production scheduling Work environment
production and service
Planning of production realization
provisions Purchasing Customer related processes
Design and development Tender Management
max IRIS Rev01 min IRIS rev01 min IRIS Rev00 ISO
What makes the difference to ISO?
1. An adequate level of formalization :
14 procedures to be documented (ISO 9001: 6)
19 processes required
i d (ISO 9001
9001: 3)
2. A pre-requisite before starting the audit :
Readiness review
12 KO questions
3 Specific rules controlling:

3.
Actors (CB global presence, railway experience, targets to

meet, auditors auditing and railway experience, training and
exams renewal
exams, renewal... )
Certification process (remote functions, auditor evaluation,
compensative and rewarding approach, Software support...)
Assessment
A guideline
id li ((readiness
di review,
i questionnaire
i i and
d
maturity levels...)
IRIS Requirements
8 Clauses of ISO 9001 Requirements

and Railway
y Industry
y Specific
p
Annex 1 - IRIS Scope of Certification

Annex
A 2 - IRIS auditor
dit time
ti chart
h t
Annex 3 - Activities to be managed for Procedure /
Processes / KPIs/Records
Annex 4 - Knock out questions
Annex 5 - Terms and definitions for the rail sector
Annex 6 - Abbrevations

Understanding Standard

IRIS Requirements
0.1 General
This international standard can be used in by internal and

external parties,
parties including certification bodies,
bodies to assess the
organizations ability to meet customer, statutory and
regulatory requirements applicable to the product, and the
organizations
own requirements.
The Quality management Principles started in ISO 9001 and ISO

9004 have been taken into consideration during the
development of this international standard

Quality Management Principles
1.CustomerFocus
2.Leadership
3.InvolvementofPeople
p
4.ProcessApproach
5 System Approach to Management
5.SystemApproachtoManagement
6.ContinualImprovement
7.FactualApproachtoDecision Making.
8.MutuallyBeneficialSupplierRelationship
y pp p

1. Customer Focus
Organizations
i i d
depend
d on their
h i customers andd therefore
h f
should understand current and future customer needs,
should meet customer requirements and strive to
exceed customer expectations
2. Leadership
Leaders establish unity of purpose and direction of the
organization. They should create and maintain the
internal environment in which people can become fully
i
involved
l d in
i achieving
hi i the i ti objectives.
th organizations bj ti
3. Involvement of People
People at all levels are the essence of an
organization and their full involvement enables
their abilities to be used for the organization's
benefit.
4. Process Approach to Management
A desired result is achieved more efficiently
when activities and related resources are
managed as a process.
5. System Approach to Management

Identifying, understanding and managing
interrelated pprocess as a system
y contributes to
the organizations effectiveness and efficiency in
achieving its objectives.
6. Continual Improvement
Continual improvement of the organization s
overall p
performance should be a p
permanent
objective of the organization.
7. Factual Approach to Decision Making

Effective decisions are based on analysis of data
and information.
8. Mutually Beneficial Supplier Relationships

An organization and its suppliers are
interdependent and mutually beneficial
relationship enhances the ability of both to
create value.

IRIS Requirements
0.2 Process Approach
WhatisaProcess?
Set of interrelated or interacting activities

which transforms inputs into outputs
Out puts from one process are typically inputs

into other processes.
Overall aim is to add value by planning and

controlling processes

Process Approach - Concept
Schematic Representation of a Process
Input Process Output
Resources: Results:
People Products
Facilities/Equipment
ili i / i S
Services
i
Materials Performance
Methods
Efficiency of process
Effectiveness of process (Results achieved
(Ability to achieve v/s.
desired results)) Resources used)

Process Model
Customer Requirements
Continual
Improvement of
Quality
Management
System
Resource
Management
g
Management Product
Responsibility Process Model Realization
Measurement,
Analysis
y and
Improvement
Product
Satisfaction Customer

What is a Process Approach?
The systematic identification and management of the

processes employed within an organization and
particularly the interaction between such processes is
referred to as the Process Approach.


IRIS Requirements
0.3 Relationship with ISO 9004
ISO 9001 and ISO 9004 are QMS standards which have been
designed to complement each other, but can also be used
independently.
0.4 Compatibility with other management system
Due consideration is given to the provisions of ISO 14001 to

enhance the compatibility of the two standards.
standards

IRIS Requirements

IRIS Requirements
0.5 Aim of IRIS Standard
Continual Improvement
Emphasizing defect prevention
Emphasizing defect reduction
Due to the importance of Project business in the rail sector, special

requirements are introduced herein for the management of Projects.
Whenever ISO 9001:2008 refers to Product or Product realization,

these requirements are (when applicable) understood to also be
applied to a Project.

Scope
1.1 General
This standard, in conjunction with ISO 9001:2008, defines

business management system requirements to be applied
throughout the whole Supply Chain of rolling stock-related
stock related and
signaling-related Products.
1 2 Application
1.2 A li ti
All requirements of this International Standard are generic and

intended to be applicable to all organizations, regardless of
type, size and product provided that they have activities in
design
g and development
p and/or manufacturing g and/or
Maintenance (fleet Maintenance, refurbishment and Component
overhaul/repairs).
Scope
1.2 Application
Where any requirement(s) of this standard cannot be applied

due to the nature of an organization and its Product, this can
b considered
be id d for
f exclusion.
l i
Where exclusions are made, claims of conformity to this

standard are not acceptable unless these exclusions are
limited to requirements within clause 7.
Such exclusions shall not affect the organizations ability or

responsibility, to provide a Product that meets customer,
statutory and regulatory requirements,
requirements where applicable.
applicable

Normative Reference
ISO 9000:2005 - Quality management systems - Fundamentals and
vocabulary
ISO 9001:2008 - Quality management systems - Requirements
ISO 9004:2009 - Managing for the sustained success of an
organization A quality management approach
IEC 62278 (EN 50126)
IEC 62279 (EN 50128)
IEC 62425 (EN 50129)
In case of a conflict between the IRIS booklet and the referenced

standard please use the referenced standard as valid.
For the IRIS scope of certification No. 19 (annex 1 Signalling) the

above IEC / EN Standards are mandatory.

Main Clause Requirements
4. Quality Management System

5. Management Responsibility
6 Resource Management
6.
7. Product Realization
8. Measurement, Analysis and Improvement

Clause No: 4
QUALITY MANAGEMENT SYSTEM

4.1 General Requirements
The organization shall establish,

establish document,
document implement and
maintain a QMS and continually improve its effectiveness in
accordance with the requirements of this International Standard.
The organization shall;
a) Determine the processes needed for the QMS & their

application throughout the organization;
b) determine the sequence and interaction of these processes;
c) determine criteria and methods needed ,
d)) ensure the availabilityy of resources and information ,

e) monitor, measure where applicable, and analyze these

processes, and
f) implement actions necessary to achieve planned results and

continual improvement of these processes.
Outsourced Process
Where an organization chooses to outsource any process that
affects product conformity to requirements, the organization shall
ensure control over such processes.
The type and extent of control to be applied to these outsourced
processes shall be identified within the QMS.
In the case of a transfer of Processes or Parts thereof that

affects product conformity to requirements within the
execution of a contract, a documented procedure
includingg feasibilityy study,
y, risk analysis,
y , p planning,
g,
communication to customer and First Article Inspection
to the appropriate level shall exist.

4.2DocumentationRequirements
4.2.1 General
The QMS documentation shall include:
a) documented statements of a
q
qualityy p
policyy and q
qualityy objectives
j
technical safety policy & safety objectives

b) a quality manual
c) documented procedures and records required by this International Standard
d) documents, including records, determined by the organization to be necessary to
ensure the effective p
planning,
g operation
p and control of its p
processes.
e) Management system requirements imposed by the applicable regulatory authorities
Ensure that personnel have access to Business Management System (BMS)
documentation and are aware of documents
Customer and/or regulatory authorities shall have access to access to the documentation

4.2.1 General
Th QMS documentation
The d t ti shall
h ll include:
i l d
e) documented statements of a technical safety policy &
safetyy objectives
j
f) Management system requirements imposed by the applicable
regulatory authorities
Ensure that personnel have access to Business Management
System (BMS) documentation and are aware of documents
Customer and/or/ regulatory authorities shall have access to
access to the BMS documentation

4.2.2 Quality Manual
Quality Manual that includes
QualityManualthatincludes
a) the scope of the QMS, including details of and justification
for any exclusions
b) the documented procedures established for the quality
management system or reference to them
c) a description of the interaction between the processes of
the quality management system.
Relationship between the requirements of this document and

the documented procedures should be clearly shown)
4.2.3 Control of Documents
A documented procedure shall be established to define the
controls needed
a)) to
t approve documents
d t for
f adequacy
d prior
i tot issue,
i
b) to review and update as necessary and reapprove
d
documents.
t
c) to ensure that changes and the current revision status of
d
documentst are identified,
id tifi d
d) to ensure that relevant versions of applicable documents
are available
il bl at points
i off use,

e)) tto ensure th t
that d
documents
t remain
i l ibl
legible, readily
dil
identifiable
f) to ensure that documents of external origin determined

are identified and their distribution controlled.
g) to prevent the unintended use of obsolete documents, and

to apply suitable identification to them if they are retained
for any purpose

Th
The organization
i ti shall
h ll demonstrate
d t t effective
ff ti managementt
and control of all documents pertinent to the Products it
supplies.
pp
Names of personnel, who authorize and carry out review
of the necessary documentation, shall be identified.
Effective systems shall be in place to review impact of
documents of external origin.
The organization shall have a Process to ensure the
traceability of customer documents throughout the entire
Supply Chain, e.g. specifications, requirements.

4.2.4 Control of Records
The organization shall establish a documented procedure to
define the controls needed for the identification, storage,
retrieval, protection, retention and disposition of records.
Records shall remain legible, readily identifiable and
retrievable.
Procedure shall also include approval of recorded results
before official release.
Records shall be available for review and/or release by /

released to customers and regulatory authorities in
accordance with contract or statutory and regulatory
requirements.
4.3KnowledgeManagement
Best practices shall be identified, documented,

i l
implemented
t d and d regularly
l l updated
d t d to
t improve
i th
the
organization's Process efficiency and Product in quality,
costs and deliveryy p
performance .
Note: This can include
g rules ((engineering
- Design g g standard))
- Manufacturing Practices
- Procedures
The organization should define and implement a process to

identify obtain,
identify, obtain protect,
protect use and evaluate information,
information
knowledge and technology.
4.3ManagementofMultiSiteProjects
In case where a Project involves multiple-sites, an

appropriate
pp p BMS shall be documented and implemented
p and
shall cover as a minimum
- Work split and operational interfaces
- Authorities and responsibilities and communicational
channels (internal and with the customer)
- A
Applicable
li bl P
Processes, P
Procedures,
d d
documents
t and
d
records on each site
- Assurance of IRIS Compliance
Efficiency of multi-site project activities should regularly be
assessed to the appropriate level (e.g. Throughout audits,
management reviews, process reviews, analyzing customer
complaints) and improved where necessary
Clause No: 5
MANAGEMENT RESPONSIBILITY

5.1ManagementCommitment
Top management shall provide evidence of its commitment
to the development and implementation of the QMS and
continually improving its effectiveness by:
a)) communicating g to the organization
g the importance
p of
meeting customer as well as statutory and regulatory
requirements.
b) establishing the quality policy
c) ensuring the quality objectives are established
d) conducting management reviews and
e) ensuring the availability of resources

5.2CustomerFocus
Top management shall ensure that customer

requirements are determined and are met with the
aim of enhancing customer satisfaction.
Company policy shall reflect the organization

organizationss
willingness to satisfy customer needs.

5.3QualityPolicy
Top management shall ensure that the quality policy
a) is appropriate to the purpose of the organization,

b) includes a commitment to comply with requirements and
continually improve the effectiveness of the quality
management system,
c) pro
provides
ides a framework
frame ork for establishing and reviewing
re ie ing
quality objectives,
d)) is communicated and understood within the organization,
g
and
e) is reviewed for continuing suitability

5.3QualityPolicy
Th organization
The i ti should
h ld define
d fi and
d implement
i l t a structured
t t d
process for strategy and policy formulation, which includes
an analysis of the needs and expectations of customers
along with an analysis of statutory and regulatory
requirements.

5.3QualityPolicy
5.3.1 Business Plan
The organization
Th i ti shall
h ll establish
t bli h and
d review
i att least
l t annually
ll
a business plan.
Minimum Requirements
- Company mission and vision
- Plan to reduce identified risks
- Market and Product strategy, including development plans of new products /
processes and phase out strategy
- Impact of changes in technologies,
technologies and in statutory and regulatory
requirements
- Make or Buy strategy
- Company capacity (current and future) and
- Business Objectives
5.3QualityPolicy
5.3.1 Business Plan
- Business Plan should be effectively and appropriately
communicated throughout the organization
- Business Plan should be supported by mid and long term
action plans in accordance with the business plan vision
- A cost management process shall be in place in order to
manage the finance of the organization, including rules for
accounting and controlling
- The organization should define and implement a process
for prediction, monitoring and controlling financial
resources.

5.4Planning
5.4.1 Quality Objectives
Top management shall ensure that quality

objectives
objectives, including those needed to meet
requirements for product are established at relevant
f
functions
ti and
d levels
l l within
ithi the
th organization.
i ti
The q
quality
y objectives
j shall be measurable and
consistent with the quality policy.

5.4Planning
5.4.1 Quality Objectives
Business Objectives should be cascaded and broken down
and reviews should be organized on a regular basis at each
level of the organization
Business
us ess Object
Objectives
es s
should
ou d add
address
ess custo
customer
e eexpectation
pectat o
and be achievable within defined timescale
The organization should define and implement a planning

process, which includes consideration of changing external
trends and interested parties needs

5.4Planning
5.4.2 Quality Management System Planning
Top management shall ensure that:
a) the planning of the quality management system is
carried out in order to meet the requirements given
in 4.1, as well as the quality objectives, and
b) the integrity of the quality management system is
maintained when changes to the quality
management system are planned and
implemented.

5.5Responsibility,Authorityand
Communication
Communication
5.5.1 Responsibility and Authority
Top Management shall ensure that responsibilities and authorities
are defined and communicated within the organization.
Ownership, Authorities and Responsibilities for all process shall

be defined
Interfaces with the customer shall be defined and

communicational channel described and communicated
Each employee
p y shall have the responsibility
p y to raise anyy issue /
deviation from the requirement to his/her manager for action
Communication
Communication
5.5.2 Management Representative
Top management shall appoint a member of the
organization s management who, irrespective of other
responsibilities, shall have responsibility and authority that
includes
a) ensuring that processes needed for the QMS are established,
implemented and maintained,
maintained
b) reporting to the top management on the performance of the QMS
and any need for improvement and,
c) ensuring the promotion of awareness of customer requirements
throughout the organization.
d) the organizational freedom to resolve matters pertaining to quality or
stop development / production / delivery / field support activities, if
critical requirements not met
Communication
5.5.3 Internal Communication
Top management shall ensure that appropriate

communication processes are established within the
organization and that communication takes place
regarding the effectiveness of the Quality Management
Syste
System.

Communication
5.5.3 Internal Communication
The organization shall establish a communication system
from Management to its personnel and vice versa, giving
consideration to, as a minimum
- Mission and vision
- Policy
- Organization performance and
- Customer related issues
The organization should also define and implement a

process for external communication
Communication
5.5.4 Customer Relationship management
Top management shall appoint a member of management who,
irrespective of other responsibilities, shall have responsibility and
authority that includes:
a)) ensuring
g that p processes needed to satisfyy customer
requirements are established, implemented and maintained,
b) reporting to the top management on the performance of these
processes and d any need
d for
f improvement
i t and,
d
c) ensuring the promotion of awareness of customer satisfaction
throughout the organization and related training.

5.6ManagementReview
5.6.1 General
Top management shall review the organizations QMS, at

planned intervals, to ensure its continuing suitability,
adequacy
d and
d effectiveness.
ff ti
This review shall include assessing opportunities for
i
improvement t and
d theth need d for
f changes
h t the
to th QMS,
QMS
including the quality policy and quality objectives.
R
Records
d from
f managementt reviews
i shall
h ll be
b maintained.
i t i d
Planned intervals
inter als shall not exceed
e ceed 12 months

5.6ManagementReview
5.6.2 Review Input
Inputs to management review shall include information on:
a) results of audits;
b) customer feedback;
c)) p
process p
performance and p
product conformity;
y;
d) status of preventive and corrective actions;
e) follow-up
follow up actions from previous management reviews;
f) changes that could affect the QMS;
g)) recommendations
d ti f improvement.
for i t

5.6ManagementReview
5.6.2 Review Input
h) Key issues from previous project reviews;
i) Result of previous process reviews;
j) analysis of actual and potential field-failures and their
impact on safety and environment
k) KPI status
- all mandatory KPIs
- customer on time delivery performance
- non conformities raised by the customer throughout the
entire project life cycle
5.6ManagementReview
5.6.2 Review Input
Input should cover
- all recommended KPIs
- Internal and supplier non conformities throughout the
entire project life cycle
- supplier on time delivery performance
- response time on non conformities raised by customer
- Quality Deficiency Costs

5.6ManagementReview
5.6.3 Review Output
The outputs from the management review shall include
y decisions and actions related to
any
a) improvement of the effectiveness of the QMS its processes;
b) improvement of product related to customer requirements,
requirements
c) resource needs
d) integration of business processes
e) Business objectives achievement
f) Customer satisfaction

Clause No: 6
RESOURCE MANAGEMENT

6.1ProvisionofResources
The organization shall determine and provide the resources
needed
a) to implement and maintain the QMS, and continually improve its
effectiveness,, and
b) to enhance customer satisfaction by meeting customer

requirements.
The organization should define and implement a process for the

planning of resources
The documented procedure shall be in place to ensure the appropriate

capacity regarding personnel, equipment, etc taking into consideration
the current order booking and forecast orders on a mid and long term
basis
6.2HumanResources
6.2.1 General
Personnel performing work affecting conformity to product

requirements shall be competent on the basis of appropriate
education, training, skills and experience.
The organization should define, implement, measure and

review human resource management
g process within the
p
management system

6.2HumanResources
6.2.2 Competence, Awareness and Training
The organization shall
a) determine the necessary competence
b) Where applicable, provide training or take other actions to achieve the
necessary competence
t
c) evaluate the effectiveness of the actions taken;
d)) ensure that its p
personnel are aware of the relevance and importance
p of their
activities and how they contribute to the achievement of the quality
objectives, and
e)) maintain appropriate
pp p records of education, training,
g skills and experience
p
f) Ensure that its personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of the safety
objectives
The organization should define and implement an Appraisal process for
systematically identifying training needs
6.2HumanResources
6.2.2.1 Product Design Skills
The organization shall ensure that personnel with
responsibility for product design have the necessary
competence to achieve design requirements and are
skilled in applicable tools and techniques.
Applicable
pp tools and techniques
q shall be identified by
y the
organization.

6.2HumanResources
6.2.2.2 Employee Motivation and Empowerment
The organization
Th i i shall
h ll motivate
i employees
l to achieve
hi
business, quality and safety objectives, to make continual
improvements and to create an environment to promote
improvements,
innovation.
Note: This could include a suggestion scheme system

6.2HumanResources
6.2.2.3 Training
The organization shall establish and maintain
documented procedures for identifying and planning
training needs in order to achieve and maintain the
necessary competence of personnel performing
activities affecting product quality and safety at all levels
of the organization.
Output of knowledge management activities shall be

taken into consideration as an input for training planning

6.2HumanResources
6.2.2.3 Training
Personnel performing specific assigned tasks (e.g.
special process, engineering change activities) shall
be competent and qualified,
qualified as required,
required with
particular attention to the satisfaction of customer,
local, statutory and regulatory requirements.
System shall be in place to maintain and upgrade

the qualification of such personnel

6.2HumanResources
6.2.2.3 Training
Critical
C iti l activities
ti iti affecting
ff ti the
th product
d t quality
lit and
d safety
f t shall
h ll
be identified and records of skilled personnel able to
undertake these activities shall be maintained and regularly
g y
updated.
Personnel whose work can affect p product q

quality
y and safetyy
shall be informed about the possible consequences to the
customer if quality and safety requirements have not been
met.
met
Appropriate induction shall be performed for temporary

workers and newcomers,
newcomers covering as a minimum product
quality and safety
6.2HumanResources
6.2.2.4 Performance Management
A system shall be established to regularly set individual
objectives linked with business objectives and review the
individual performance
Note: The system

y can also address the needs for training
g
and development of individual people. On shop floor level,
team objectives can be considered as sufficient individual
objective.

6.3Infrastructure
The organization
g shall determine,, p
provide and maintain the
infrastructure needed to achieve the conformity to product
requirements.
q Infrastructure includes, as applicable
pp
a) buildings, workspace and associated utilities;
b) process equipment (both hardware and software); and
c)) supporting
pp g services ((such as transport,
p communication or
information systems).

6.3Infrastructure
d) Planned maintenance activities
e) Packaging, storage and preservation/condition check of equipment /

tools / fixtures and measurement equipment;
f) Availability
A il bilit off spare parts
t and
d consumables
bl f key
for k manufacturing
f t i
equipment and
g) Documenting,
g, evaluating
g and improving
p g maintenance objectives.
j
The organization should utilize predictive maintenance methods to

continually improve the effectiveness and the efficiency of production
equipment.
The organization should periodically review the infrastructure and
related processes with the future in mind.

6.4WorkEnvironment
The organization shall determine and manage the work

environment needed to achieve conformity to product
requirements
The organization should determine and implement

processes to ensure that the work environment
complies with all applicable statutory and regulatory
requirements.

6.4WorkEnvironment
Product
P d t safety
f t and d means to t minimize
i i i potential
t ti l risks
i k tot
employees shall be addressed by the organization,
especially
p y in the design
g and development
p process and in the
p
production process activities.
The organization shall maintain its premises in a

state of order,
order cleanliness and repair consistent
with the product and production process needs.

6.5ContingencyPlan
The organization shall prepare contingency plans to

mitigate the event of an emergency such as utility
interruptions, interruptions in the supply chain,
labour shortages, key equipment failure and field
returns

Clause No: 7
PRODUCT REALIZATION

7.1PlanningofProductRealization
The organization shall plan and develop the processes needed for
product realization.
realization
In planning Product Realization the organization shall determine
the following, as appropriate:
a) quality objectives and requirements for the product,
b) the need to establish processes, documents and provide resources
specific to the product.
product
c) required verification, validation, monitoring, measurement, inspection
and test activities, specific to the product and the criteria for product
acceptance
d) records needed to provide evidence that the realization processes
and resulting product meet requirements
The organization should define, implement and manage key
processes
7.2CustomerRelatedProcess
7.2.1 Determination of requirements related to the
Product
The organization shall determine,
a) requirements specified by the customer,
customer including the
requirements for delivery and post-delivery activities;
b)) requirements
q not stated byy the customer, but necessaryy for
specified or intended use, where known;
c) statutory and regulatory requirements applicable to the
prod ct
product,
d) any additional requirements determined by the organization
A detailed internal total cost breakdown shall be determined

7.2.2 Review of requirements related to the Product
The organization shall review the requirements related to the
product. This review shall be conducted prior to organizations
commitment to supply a product to the customer and shall ensure
that:
a) product requirements are defined;

b) contract
t t or order
d requirements
i t differing
diff i from
f th
those previously
i l
expressed are resolved;
c) the organization has the ability to meet the defined
requirements.
requirements
Records of the results of the review and actions arising from the
review shall be maintained

Where the customer provides no documented
statement of requirement, the customer
requirements shall be confirmed by the organization
before acceptance.
Where product requirements are changed, the

organization shall ensure that relevant documents
are amended and that relevant personnel are made
aware of the changed requirements.

The organization should define and implement a change

Process,, which includes a change
g control board.
A multi disciplinary approach (including suppliers when

appropriate) shall be used.
used
Project Management and design / development shall be

appropriately represented in all requirements
requirements' reviews.
reviews

The organization shall have a Process to ensure that identified
requirements are:
a) individually checked for compliance (e.g. clause by clause),

b) negotiated and updated with impact on the offer identified,
c)) evaluated and taken into account,,
d) properly transferred, understood, acknowledged and committed
to by everybody involved and
e) complete, clear, precise, unequivocal, verifiable, testable,
maintainable and feasible.
The performance of this Process should be measured by a KPI

Thi
This Process
P shall
h ll also
l control
t l contract
t t variation
i ti i l di
including
liaison with customers.
The Process shall be applied for all the phases: submission of
tenders, acceptance of contracts or orders, acceptance of
changes to contracts or orders.
Deficiencies identified during the Process shall be managed
and corrected by the organization.
In order to avoid risks and to allow a smooth Project / Product
realization, reviews shall cover as a minimum the aspects:
Critical Product characteristics; customer statutory and
regulatory requirements; scope; time; cost; quality; resources;
communication; risk; changes.
g

Reports
R t should
h ld be
b issued
i d to
t senior
i managementt and d regularl
reviews should be held with them (allowing proactive activities)
covering:
actual situation vs. planned situation in terms of time,

forecast (time to complete),
contingency activities, mitigation plans,
actualization of risk assessment and
follow-up of open issue list.
Risks shall be identified, monitored and mitigated when applicable.

Risks shall be communicated internallyy and to the customer, if
applicable.

7.2.3 Customer Communication
The organization shall determine and implement

effective arrangements for communicating with
customers in relation to
a) product information;
b) enquiries, contracts or order handling, including
amendments, and
c) customer feedback, including customer complaints

7.2.3 Customer Communication
The organization shall define and implement effective

arrangements for communicating any information related to
th delivery
the d li i accordance
in d with
ith off the
th customers'
t ' contractual
t t l
requirements in the Value Chain.
The organization should also define and implement a

Process for external communication.

7.2.4 Tender Management
In addition to the requirements related to the Product (see
clause 7.2.2), the organization shall have a Process and
should have a documented Procedure to ensure that
requirements
i t identified
id tifi d during
d i theth tender
t d phase
h are:
a) individually checked for compliance (e.g. clause by clause),

b) negotiated and updated with impact on the offer identified,
c) evaluated and taken into account,
d)) pproperly
p y transferred,, understood,, acknowledged g and
committed to by everybody involved and
e) complete, clear, precise, unequivocal, verifiable, testable,
maintainable and feasible.
feasible
The performance of this Process shall be measured by a KPI
7.2.4 Tender Management
Prior
P i tot the
th submission
b i i off the
th quotation,
t ti th organization
the i ti
shall use a Multidisciplinary Approach (including suppliers
when appropriate)
pp p ) to investigate
g customer and statutoryy and
regulatory requirements. Also the organization shall confirm
and document the feasibility of the proposed Products in the
tender.
tender
During the tender review the organization shall approve the
offer including planning,
planning resources and pricing.
pricing
As a minimum, Project/Product requirements as well as risks

and
d opportunities
t iti shall
h ll be
b id tifi d controlled
identified, t ll d and d
validated.
7.3DesignandDevelopment
The organization shall establish and maintain a Process for design

and development and should document it in a Procedure.
The performance of this Process shall be measured by a KPI.
The organization should define and implement an innovation

Process for new Products and Processes, which is able to identify
changes in the organization's business environment, and to plan
innovations.
Every new technology / new Product Shall fulfil the design and
development requirements described in clause 7.3.

The principles applied in developing high integrity
systems shall be in line with the IEC standards or other
agreed equivalent models
The software design Process shall explicitly implement
the appropriate requirements (e.g. IEC 62279 (EN
50128)) related to the Safety Integrity level of the intended
IRIS scope
p of certification.
Documentation and training related to the application of
the Product shall be considered as integral part of the
system to be designed and developed,
developed especially in a
Safety critical environment.
The organization shall have the capability to provide this
where required for safe use.

7.3.1 Design and Development Planning
The organization shall plan and control the design and
development of the product.
Th organization
The i ti shall
h ll determine
d t i
a) the design and development stages;
b) the
th review,
i verification
ifi ti andd validation,
lid ti and
d
c) the responsibilities and authorities
The organization shall manage interfaces between different
groups involved
Planning output shall be updated,
updated as appropriate,
appropriate as the
design and development progresses
7.3.1 Design and Development Planning
The organization should define and implement a collaboration Process
and indicators to measure its efficiency.
The organization shall determine task sequence, mandatory steps,

significant stages and method of configuration control.
Where appropriate, due to complexity, the organization shall give

consideration to the following activities:
structuring the design effort into significant elements and
for each element, analyzing the tasks and the necessary resources for
design and development.
development
This analysis should consider an identified responsible person, design
content, input data, planning constraints and performance condition.
Design concepts, e.g. design for Safety, design for maintainability and design for
environment, should be investigated and applied where appropriate.
7.3.2 Design and Development Inputs
Inputs shall include:
a) functional and performance requirements;
b) applicable statutory and regulatory requirements
c) where applicable, information derived from previous
similar designs and;
d) other requirements essential for design and
de elopment
development.
These inputs shall be reviewed for adequacy. The
requirements shall be complete,
complete unambiguous and not in
conflict with each other.
7.3.2 Design and Development Input
The organization
Th i ti shall
h ll ensure that
th t new technologies/new
t h l i /
Products (designed to meet market needs) are validated
before introduction into a customer Project.
j
RAMS/ LCC shall be considered as design inputs.
End of life of Products should be considered as design

input.

7.3.3 Design and Development Outputs
Design and development outputs shall
a) meet the input requirements for design and development,

development
b) provide appropriate information for purchasing,
production and service provision,
c) contain or reference product
prod ct acceptance criteria,
criteria and
d) specify the characteristics of the product that are
essential for its safe and proper use.

7.3.3 Design and Development Outputs
The organization
Th i ti should
h ld define
d fi and
d implement
i l t a Process,
P
which ensures that approval is carried out by sufficient
competent
p staff .
The design and development output shall be expressed in

terms that can be verified against Production Process input
requirements.

7.3.4 Design and Development Review
At suitable stages, systematic reviews of design and development

shall be performed in accordance with planned arrangements
a) to evaluate the ability of the results of design and

development to meet requirements, and
b) to identify any problems and propose necessary actions.

Participants in such reviews shall include representatives of
functions concerned.
Records of the results of the reviews and any necessary actions
shall be maintained .

7.3.4 Design and Development Review
In addition to the ISO9001:2008, systematical reviews of design and
development shall be performed.
c) to authorize progression to the next stage.
The organization should define and implement a design review Process.
Measurements at specified stages of design and development should be

defined, analyzed and reported as an input to management/Project
review.
review
Reviews shall also involve other functions as appropriate to review the

Product characteristics (e.g.
(e g costs,
costs RAMS and serviceability).
serviceability)

7.3.5 Design and Development Verification
Verification shall be performed in accordance with

planned arrangements to ensure that the design
and development outputs have met the design and
development input requirements.
Records of the results of the verification and any

necessaryy actions shall be maintained.

7.3.6 Design and Development Validation
Design and development validation shall be performed in

accordance with p
planned arrangements
g to ensure that the
resulting product is capable of meeting the requirements for
the specified application or intended use,
use where known.
known
Wherever practicable, validation shall be completed prior to

the delivery or implementation of the product. The records of
the results of validation and anyy necessaryy actions shall be
maintained
Design and development validation shall be

demonstrated for all identified operational
conditions.
The organization shall apply the validation concepts,

concepts
organization and methods as mandated by
applicable standards
A documented Procedure shall be in place in the

event that tests are necessary for validation.
These tests shall be planned, controlled, reviewed and
documented to ensure and prove the following:
a)test plans or specifications identify the Product being tested and the
resources being used, defining test objectives and conditions, parameters
to be recorded and relevant acceptance criteria, test conditions and
reproducible environment,
b) test Procedures describe the method of operation, the performance of
the test and the Recording of the results,
c)) the
th correctt configuration
fi ti off the
th Product
P d t isi submitted
b itt d for
f the
th test,
t t
d) the requirements of the test plan and the test Procedures are observed
e) the acceptance criteria are met.

7.3.7 Control of Design and Development Changes
Design
D i and
d development
d l t changes
h shall
h ll be
b identified,
id tifi d and
d
records maintained.
The changes shall be reviewed,
reviewed verified and validated,
validated as
appropriate, and approved before implementation.
The review of design and development changes shall include
evaluation of the effect of the changes on constituent parts and
product already delivered.
Records of results of the review of changes and any necessary
actions shall be maintained
Have a process to control deferred and abnormal work in design
and development
7.3.8 Design Approval
In the case that IEC 62279 (EN 50128) in conjunction with a

Safetyy Integrity
g y Level is required,
q , the organization
g shall
provide a documented Procedure defining the Safety Case
and approval in line with this standard.
standard

7.4Purchasing
7.4.1 Purchasing Process
The organization shall ensure that the purchased product
conforms to specified purchase requirements.
The type and extent of control applied to the supplier and the
purchased product
Evaluate and select suppliers based on their ability to supply

products.
Criteria for selection,

selection evaluation and re-evaluation
re evaluation shall be
established.
Records of the results of evaluations and any necessary actions

arising from the evaluation shall be maintained
7.4Purchasing
IIn addition
dditi tot ISO 9001:2008,
9001 2008 the
th organization
i ti shallh ll ensure
that a Process for purchasing of Products is in place.
The organization should define and implement a Process

to select, evaluate, re-evaluate and rank suppliers.
The performance of this Process shall be measured by a

KPI
The organization shall provide a documented Procedure

covering
g p
purchasing g Process activities that affect Product
conformity to requirements.
7.4Purchasing
Th organization
The i ti shall
h ll implement
i l t a system
t t ensure the
to th quality
lit off allll
Products purchased from suppliers,
Products p
purchased from customer designated
g suppliers.
pp
The organization shall:
a) maintain and use a register of approved suppliers

b) ensure that customer requirements are cascaded down through the
Supply Chain
c) ensure that the function having responsibility for approving supplier
quality systems has the authority to reject the use of sources and
d) assess and manage the risks for supply of Critical Products throughout
the
h Supply
S l Chain.
Ch i

7.4Purchasing
Th
The organization
i ti should:
h ld
a) periodically review supplier performance;
b) define the necessary action to be taken when dealing with suppliers
that do not meet technical and/or performance targets.
targets
The organization shall develop suppliers with the goal of improving

supplier operational performance.
performance
The organization should define and implement a relationship Process

to develop
p key
y suppliers.
pp
Unless otherwise specified by the customer suppliers to the

organization should be certified according to ISO9001:2008 by an
accredited third party certification body.

7.4Purchasing
7.4.2PurchasingInformation
Purchasing information shall describe the product to be
purchased, including where appropriate
a) requirements for approval of product,
product procedures,
procedures
processes and equipment
b)) requirements
q for q
qualification of p
personnel
c) quality management system requirements.
The organization shall ensure the adequacy of specified

purchase requirements prior to their communication to the
supplier.
li

7.4Purchasing
d) the name or other identification, applicable issues of specifications,
drawings, Process requirements (including special ones), inspection
instructions, appropriate details from the organization's quality plan
and other relevant technical data,
e) requirements for design, test, examination, inspection and related
instructions for acceptance by the organization,
f) requirements for test specimens (e.g. Production method, number,
storage conditions) for design approval, inspection, investigation or
auditing,
g) requirements relative to
supplier notification to organization of nonconforming Product and
arrangements for organization approval of supplier nonconforming
material.

7.4Purchasing
h)) requirements
equ e e ts for o tthe
e supp
supplier
e to notify
ot y tthe
eoorganization
ga at o o of cchanges
a ges in Product
oduct
and/or Process definition and, where required, obtain organization approval,
i) right of access by the organization, their customer and regulatory authorities
to all facilities involved in the order and to all applicable Records,
j) requirements for the supplier to cascade to its suppliers, the applicable
requirements in the purchasing documents, where required,
k) requirements for Supply Chain logistics and
l) requirements for all Deliverables associated to the Product.
Product
The organization shall ensure that the supplier's offer is selected only after
tthorough
o oug a analysis
a ys s p
prior
o to negotiation.
egot at o Thee negotiation
egot at o s shall
a tatake
e into
to
account:
the level of compliance with the purchasing information,
the total cost requirements (including LCC) and
previous Product quality, costs and delivery performances.

7.4Purchasing
7.4.3VerificationofPurchasedProducts
The organization shall establish and implement the

inspection or other activities necessary for ensuring that
th
the purchased
h d product
d t meets t specified
ifi d purchase
h
requirements.
Where the
Wh th organization
i ti or its
it customer
t i t d to
intends t
perform verification at the supplier s premises, the
organization shall state the intended verification
arrangements and method of product release in the
purchasing information.

7.4Purchasing
The organization should define
f and implement a Process for
f verification
f
activities, like inspection or audit at supplier's premises, which is
supported by checklists and templates.
Verification activities of the organization shall include:
a) obtaining objective evidence of the quality of the Product from

suppliers (e.g., accompanying documentation, certificate of conformity,
test reports, statistical Records, Process control),
b)) review of the required
q documentation and
c) inspection of Products upon receipt.
Verification activities of the organization should also include inspection

and audit at supplier's premises.

7.4Purchasing
The purchased Product shall not be used or Processed until it has been
verified as conforming to specified requirements or unless it is released
under authorized customer Concession.
Where the organization utilizes test reports to verify purchased Product

the data in those reports shall be acceptable per applicable
specifications.
The organization shall periodically verify test reports for raw material.
The organization shall define activities accordingly in case of delegation

of verification to the supplier or supplier certification.
Where the organization delegates verification activities to the supplier,

supplier the
requirements for delegation shall be defined and a register of supplier
delegations maintained.
7.4Purchasing
7.4.4SupplychainManagement
Supplier deliveries shall be scheduled in order to meet the purchase
requirements.
Ordering shall be supported by an information system which:

covers the supply,
permits access to customer, supplier and Production information at
keyy stages
g of the ppurchasing
g Process and
is order driven.
The organization
g shall communicate regularly
g y a forecast to its supplier
pp
so that they can manage their capacity accordingly.
Supplier shortages
g shall be identified, communicated to the
organization, controlled and actions shall be established to recover the
delivery schedule.
7.5ProductionandServiceProvision
The organization shall ensure that the Production Process inputs

are expressed in terms that can be verified against design and
development output requirements, including:
specifications and drawings,

information on materials,
Production Process flow chart / layout,
layout
control plan, work instructions,
Process and Product approval acceptance criteria,
data for quality,
quality measurement,
measurement reliability,
reliability maintainability,
maintainability
results of error prevention activities (e.g. FMEA),
methods of rapid detection and feedback of Product /
Production Process nonconformities.
nonconformities

7.5.1ControlofProductionandServiceProvision
The organization shall plan and carry out production and service
provision under controlled conditions. Controlled conditions shall include,
as applicable:
a) the availability of information that describes the characteristics of the
product;
b) the availability of work instructions, as necessary
c) the use of suitable equipment
d) the availability and use of monitoring and measuring equipment;
e) the implementation of monitoring and measurement, and
f) the implementation of product
prod ct release,
release delivery
deli er and post - delivery
deli er
activities.
7.5.1ControlofProductionandServiceProvision
In addition to the ISO 9001:2008, controlled conditions shall include
for all shifts:
g) accountability for all Products during manufacturing (e.g. parts

quantities, split orders, nonconforming Product),
h) evidence that all manufacturing and inspection operations have

been authorized and Completed as planned in the Production
schedule or as otherwise documented.
The organization shall have a Process to control deferred and

Abnormal Work in Production.

7.5.1.1ProductionScheduling
Production (including test equipment) shall be:
scheduled (short-, mid- (MPS = Master Production Schedule) and
long-term (SOP = Sales and Operation Plan)) in order to meet the
customer purchase
h requirements,
i
supported by an information system that permits access to Production
information
o at o at key
ey stages o
of tthe
e Process
ocess a
and
doorder
de ddriven.
e
The organization shall use customer forecasts and orders to plan,

measure capacity
p y and adjust
j regularly
g y its resources according g to its
workload, taking into account risks (e.g. extra order at the last minute,
supplier failure).
Bottlenecks in Production shall be identified and an improvement
p action
plan established.

7.5.1.2 Production documentation
Production operations shall be carried out in accordance with

approved data.
This data shall contain when necessary:
a) drawings,
drawings parts lists,
lists Process flow charts including inspection
operations, Production documents (e.g. manufacturing plans,
traveller, router, work order, Process cards) and inspection
documents and
b) a list of tools and numerical control (NC) machine programs

required and any specific instruction associated with their use.
use

7.5.1.3 Control of Production Process changes
The organization shall establish, document and maintain a

Process to control Production Process changes.
Persons authorized to approve changes to Production Processes

shall be identified.
The organization shall identify and obtain acceptance of changes

that require customer and/or regulatory authority approval in
accordance
d with
ith customer
t contracts
t t and/or
d/ statutory
t t t and
d
regulatory requirements.

7.5.1.3 Control of Production Process changes
Changes affecting Processes, Production equipment, tools and

programs (software) shall be documented.
The results of changes to Production Processes should be

reviewed to confirm that the desired effect has been achieved
without
ou ad
adverse
e se e
effects
ec s to
o Product
oduc qua
quality.
y
The organization shall maintain a Record of the date and/or serial

number of each change which is implemented in Production.

7.5.1.4 Control of equipment and tools
The organization shall have a documented Procedure for

providing adequate manufacturing equipment and tools to
produce Products according to the design output.
The organization
g should apply
pp y the design
g and development
p
Process (see clause 7.3) for manufacturing equipment (e.g.
tools, jigs, fixtures).

7.5.2 Validationofprocessesforproduction&service
provision
provision
The organization shall validate any processes for production
and service provision where the resulting output cannot be
verified by subsequent monitoring or measurement and, as a
consequence, deficiencies become apparent only after the
product is in use or the service has been delivered.
p
Validation shall demonstrate the ability of these processes to

achieve
hi planned
l d results.
lt

provision
provision
The organization shall establish arrangements for these
processes including,
i l di as applicable:
li bl
a) defined criteria for review and approval of the processes;
b) approval of equipment and qualification of personnel;
c) use of specific methods and procedures;
d) requirements for records and
e) revalidation
provision
provision
The organization should define and implement a Process for
validation of Processes for Production and service provision.
Special Processes shall be managed according to the contractual
and/or internal requirements.
The organization shall establish a Process for the control of

Special Processes, including qualification and approval of the
Special Processes prior to use and in accordance with
documented specifications and any subsequent changes thereto.
All personnel performing Special Processes shall be identified,

identified
trained and authorized.
7.5.3IdentificationandTraceability
Where appropriate, the organization shall identify the product by

g
suitable means throughout product realization.
p
The organization shall identify the product status with respect to

monitoring
it i and
d measurementt requirements
i t throughout
th h t product
d t
realization.
Where traceability is a requirement, the organization shall control

the unique identification of the product and maintain records

7.5.4CustomerProperty
The organization shall exercise care with customer property while
it is under the organization s control or being used by the
organization.
g
The organization shall identify, verify, protect and safeguard
customer property provided for use or incorporation into the
p
product.
If any customer property is lost, damaged or otherwise found to be
unsuitable for use, the organization shall report this to the
customer and maintain records.
NOTE: Customer-owned returnable packaging is included in this

clause.
clause

7.5.5PreservationofProducts
The organization shall preserve the conformity of product

during internal processing and delivery to the intended
destination in order to maintain conformity to requirements.
As applicable, preservation shall include identification,

handling, packaging, storage and protection. Preservation
shall also apply to the constituent parts of a product.

7.5.5PreservationofProducts
Preservation of Product should also include, in accordance
with Product specifications and/or applicable regulations,
provisions
p o s o s for:
o
a) cleaning,
b) special handling for sensitive Products,
c) marking and labelling,
d) shelf life control and stock rotation,
e) special handling for hazardous materials.
The organization shall ensure that Product documentation

required by the contract/ order is present at delivery and is
protected against loss and deterioration.
7.6ControlofMonitoringandMeasuring
Equipment
The organization shall determine the monitoring and
measurement to be undertaken
The organization shall establish processes to ensure that
monitoring and measurement can be carried out and are carried
outt in
i a manner that
th t is
i consistent
i t t with
ith the
th monitoring
it i andd
measurement requirements.
Where necessaryy to ensure valid results,, measuring
g equipment
q p
shall:
a) be calibrated or verified, or both, at specified intervals, or
prior to use,
use against measurement standards traceable to
international or national measurement standards;
b) be adjusted or re-adjusted as necessary;
c) Have identification in order to determine its calibration status
Equipment
d) be safe guarded from adjustments that would invalidate the
measurement results
e) be protected from damage and deterioration during handling,
maintenance and storage;
In addition, the organization shall assist and record the validity of the
previous measuring results when the equipment is found not to conform
to requirements. The organization shall take appropriate action on the
equipment and any product affected.
Records of the results of calibration and verification shall be maintained.
Wh
When used d in
i th
the monitoring
it i and
d measurementt off specifiedifi d
requirements, the ability of computer software to satisfy the intended
application shall be confirmed. This shall be undertaken prior to initial
use andd reconfirmed
fi d as necessary.

Equipment
In addition to the ISO 9001:2008, measurement equipment shall
f) be recalled in accordance with a defined method when requiring

calibration.
The organization
Th i i should
h ld define
d fi and
d implement
i l a Process,
P h
how to
react when monitoring and measuring equipment is found not to
conform to requirements.
The organization shall maintain a register of this monitoring and

measuring equipment and define the Process employed for its
calibration
lib ti i l di
including d t il off equipment
details i t type,
t unique
i id tifi ti
identification,
location, frequency of checks, check method and acceptance criteria.
The organization shall ensure that ambient conditions are suitable for
the carrying out calibration, inspection, measurement and testing.
7.7Projectmanagement
The organization shall implement a Project Management

Process or new Product development Process,
Process addressing the
applicable areas of Project Management, describing roles and
responsibilities, integrating all relevant functions of the
organization
i ti into
i t a multidisciplinary
ltidi i li t
team.
NOTE
1.The Scope
p of Project
j Management
g Process is from tender
phase until the end of warranty period (Project Life Cycle).
2. If applicable in the Project

2 Project, the required SIL level has to be
taken into consideration.
7.7.1 Integration management
An integrated Project plan shall be developed, reflecting the specific rules

to follow whilst executing
g a Project
j ((e.g.
g multi Site Project)
j ) throughout
g the
entire Project Life Cycle, including Project plan change control.

7.7.2 Scope management
The organization shall ensure that the entire scope of work is

identified, subdivided into work packages, controlled and
verified.
Scope
p changes
g shall be controlled and consistencyy
guaranteed throughout the Project and reflected in the
Project plan.

7.7.3 Time management
The organization
Th i ti shall
h ll ensure timely
ti l completion
l ti off the
th Project
P j t
through the identification of:
specific activities to produce the Project Deliverables,
interdependencies of the work packages including those of
suppliers,
activity sequences, resource requirements and duration and
the critical path.
These integrated activities (e.g. Project schedule) shall be

regularly reviewed, controlled and recorded.
In any
y case of an imminent deviation the organization
g shall identifyy
and implement appropriate counter measures to avoid any impact
on customers.
7.7.3 Time management
The organization
Th i ti shall
h ll nott change
h th delivery
the d li schedule
h d l
unless authorized by the customer.
Project schedules shall be regularly updated with regard to:

development activities with suppliers (major milestones with
suppliers) and the identification and management of long
lead time items.

7.7.4 Cost management
A cost management Process shall be in place:
to
to plan all Project related costs during the whole Project Life
Cycle,
to regularly follow the cost progress on each work package and
on each item of the total cost breakdown,breakdown including the
identification of the estimate to completion.
Cost savings should be identified in order to recover the budget in

case of deviation.
deviation

7.7.5 Quality management
The organization shall ensure that a Process is in place to manage

Project Deliverables. As a minimum, the Project Deliverables shall
be managed with regard to:
identification, clarification, fulfillment and control,

validation
a da o a and
d de
delivery
eyo on time,e,
approval by the customer (e.g. customer Product acceptance
points), where required and
management
management of the suppliers within the Project (e.g. listing,
criticality, innovation, actions, Sites).
Open issues shall be controlled and the appropriate resources put

in place to manage the associated activities.
7.7.5 Quality management
Documented Project reviews shall take place at regular intervals

throughout the entire Project life.
Phase reviews shall take place at predefined Project phases /

milestones to assess the Project compliance, the availability of work
package Deliverables and to authorize the start of the next phase.
The organization's risk and opportunity management Process shall be

employed to rectify any issue /deviation arising from these reviews in
order to maintain the Project plan and schedule.
Assessment of the Project performance shall be established to

monitor the Project progress and efficiency through performance
indicators.
7.7.6 Human resources management
Requirements described in clause 6.2 of this standard with regard

to competence, awareness and training, motivation and
empowerment and performance management shall be deployed at
Project team level.
It shall cover as a minimum:
identification, documentation and assignment of Project roles,

responsibilities and reporting relationships,
acquisition of appropriate resources assigned to and working until
Project completion and
development
development of individual and team competencies to enhance
Project performance.
7.7.7 Communication management
The organization shall ensure that the Project team

determines and communicates needs of the stakeholders
(e g communication plan).
(e.g. plan)
This information, including performance information, Product

specific
ifi requirements,
i t defect
d f t reporting
ti andd Rail
R il Industry
I d t
Risks, shall be made available to Project stakeholders in an
adequate
q timelyy manner.

7.7.8 Risk and opportunity management
The organization shall ensure that a Process is in place to

identify, analyze (quantitatively and qualitatively) and when
necessary decide upon the risk response (e.g.(e g acceptance,
acceptance
mitigation, transfer, avoidance).
The Process
Th P should
h ld be
b documented
d t d in
i a Procedure
P d and
d
should include methods such as documented risk
assessment,, FMEA and control of counter measures.
The risk response or opportunity enhancement shall be

recorded and reported to all stakeholders as appropriate.
appropriate

7.7.8 Risk and opportunity management
The effectiveness of the response plan shall be assessed on a

regular basis (e.g. during the Project reviews).
The output
Th t t off the
th risk
i k assessmentt shall
h ll be
b regularly
l l reviewed
i d and
d
updated throughout the Project Life Cycle and should be
extracted and communicated for the purpose of lessons to be
l
learnt
t throughout
th h t theth organization.
i ti
The organization shall demonstrate

appropriate awareness of the Criticality of the Product and the
function and risks of a Product within the system / vehicle of which
it forms a part,
assurance of appropriate Production control Procedures to
implement risk mitigation.
7.8ConfigurationManagement
configuration management Process appropriate to the Product.
The organization should have a documented procedure for

configuration management.
The organization shall:

a)at
) t the
th beginning
b i i off the
th contract,
t t define
d fi a list
li t off Products
P d t - att
least Safety critical ones including their Component parts, which
shall be managed with regard to their configuration; this list shall
b approved
be d by
b theth customer,
t
b) address the change management Process within the
configuration management Process
c) maintain traceability during Production and operations.
7.9FirstArticleInspection
The organization shall provide a documented Procedure covering the
inspection, verification, documentation and update of Records with
results of a representative item from the first series Production run of
a new Product or major upgrade of an existing Product, following:
the
h verification
ifi i off the
h Production
P d i Process
P or
a change that invalidates the previous First Article Inspection result.
The organization
Th i ti shall
h ll ensure that
th t a Process
P i in
is i place
l t plan,
to l
initiate and conduct a First Article Inspection.
Th performance
The f off this
thi Process
P should
h ld be
b measured
d by
b a KPI
This FAI Procedure and Process shall be applied to suppliers

according to defined and agreed criteria.
criteria

7.10Commissioning/CustomerService
Where commissioning / Customer Service is a contractual

requirement, a Process shall be in place. This Process shall
include
a)actions to be taken when problems are identified after delivery,

including investigation, reporting activities and actions on service
information,
b) the control and updating of technical documentation and its
publication,
c)the approval, control and use of repair schemes,
d) the management of consignment Stock

7.10Commissioning/CustomerService
The organization shall demonstrate that adequate customer
support
pp is p
provided during
g commissioning
g
until Product validation is complete,

during
during warranty,
until final customer acceptance.
Suitable resources shall be available to provide customer support

in accordance with the agreed requirements, for all the after sales
activities including supply of spare parts.
Maintenance contracts shall be managed in accordance with the

requirements defined in clause 7 Product realization.

7.11RAMS/LCC
Maintainability of the Product shall be an integrated part of the
design and development Process.
Standardized routines for the Maintenance of software shall be

established and recorded according to IEC 62278 (EN 50126), IEC
62279 (EN 50128), IEC 62425 (EN 50129) or other agreed
equivalent models in accordance with the design and development
Process.
The organization shall have a documented Procedure in place to

cover all the aspects
p of RAMS activities,, including:
g
calculation and documentation,
data collection, analysis and improvement action plan set up,
implementation of defined tasks of the action plan.

7.11RAMS/LCC
The organization shall have a Process in place to manage LCC

and should document it in a Procedure.
Resources shall be in place to address the RAMS / LCC

requirements.
requirements
RAMS / LCC data collection and analysis shall be supported by

past experience from operation,
operation during and after warranty period
and continually improved.

7.12ObsolescenceManagement
The organization shall establish a Process to ensure, for the

defined and agreed Product life cycle, the availability of the
supplied Products and spare parts.

7.13ControlofChanges
The organization shall establish a Process and a documented

Procedure to implement,
implement execute,
execute control and react to changes
that impact Product realization, including the definition of which
changes need to be referred back to the customer for
a thori ation in line with
authorization ith local and customer
c stomer requirements.
req irements
The affect of any change, including those changes caused by any

supplier
li (
(e.g; changes
h off subcontractor,
b t t l
location,
ti P d ti
Production
Process, standard) and by customers (e.g. for new Product
introduction) shall be assessed and verified.
Validation and approval activities shall be defined to ensure

compliance with customer requirements before implementation.

7.13ControlofChanges
Changes should be analyzed regarding the impact of testing and

side effects.
effects
The organization shall have controls in place which prevent

changes from external
e ternal origin being implemented without
itho t prior
authorization from all appropriate stakeholders.
The impact
Th i t off change
h on form,
f fit and
d function
f ti or proprietary
i t
designs (including performance and/or durability) shall be
reviewed with the customer so that all effects can be properly
evaluated.
l d

Clause No: 8
MEASUREMENT, ANALYSIS AND
MEASUREMENT
IMPROVEMENT

8.1General
The organization
g shall p
plan and implement
p the monitoring,
g,
measurement, analysis and improvement processes needed
to demonstrate conformity to product requirements
to ensure conformity of the quality management system,
and
to continually improve the effectiveness of the quality
management system
This shall include determination of applicable methods,
i l di statistical
including t ti ti l techniques,
t h i and
d the
th extent
t t off their
th i use.
g
The organization shall ensure that a Process for
measurement, analysis and improvement is in place.
8.2MonitoringandMeasurement
8.2.1Customersatisfaction
As one of the measurements of the performance of
the quality management system, the organization
shall monitor information relating to customer
perception as to whether the organization has met
customer requirements.
The methods for obtaining and using this
information shall be determined.

8.2.1Customersatisfaction
The organization should define and implement a monitoring Process,
which is performed in a systematic and planned way, and includes cross
checks with external data sources.
The organization should define and implement Processes for tracking

statutory and regulatory requirements.
The organization shall implement a Process for obtaining and evaluating

customer satisfaction data.
The performance of this Process should be measured by a KPI
Root cause analysis of the main issues should be done with special
emphasis on customer related issues.

8.2.2InternalAudit
The organization shall conduct internal audits at planned
intervals to determine whether the quality management system :
9 conforms to the planned arrangements to the requirements
off this
thi I t
International
ti l Standard
St d d and d to t th
the quality
lit
management system requirements established by the
organization; and
9 is effectively implemented and maintained.
An audit program shall be planned, taking into consideration, the
status and importance of the processes and areas to be audited,
audited
as well as the results of previous audits. The audit criteria,
scope, frequency, and methods shall be defined. Selection of
auditors and conduct of audits shall ensure objectivity
j y and
impartiality of the audit process. Auditors shall not audit their
own work.
8.2.2InternalAudit
A documented procedure shall be established to define the
responsibilities and requirements for planning and conducting
audits, establishing records and reporting results.
Records of the audits and their results shall be maintained
The management responsible for the area being audited shall
ensure that any necessary corrections and corrective actions are
taken without undue delay to eliminate detected nonconformities
and their causes. Follow-up activities shall include the
verification of the actions taken and the reporting of verification
results.
results

8.2.2InternalAudit
The organization
Th i ti should
h ld define
d fi and
d implement
i l t a Process
P f
for
data gathering.
Internal auditors of relevant functions shall be qualified to ensure

that rules of auditor behaviour are applied and IRIS
requirements
q of relevant chapters
p are understood.
The organization shall audit all Processes of its management

system to verify compliance with all requirements (including any
external requirements).
The audit program shall cover all Production shifts,

shifts if applicable.
applicable

8.2.3 Monitoring and Measurement of Processes
The organization shall apply suitable methods for
monitoring and, where applicable, measurement of the
QMS Processes.
P
These methods shall demonstrate the ability of the
processes to achieve planned results. When planned
results are not achieved, correction and corrective
action
ti shall
h ll be
b taken,
t k as appropriate.
i t
Mandatory and recommended KPI KPIss shall be established as

listed in annex 3 to measure and monitor Processes.
8.2.4 Monitoring and Measurement of Product
The organization shall monitor and measure the characteristics of the
product to verify that product requirements have been met. This shall
be carried out at appropriate stages of the product realization process
in accordance with the planned arrangements. Evidence of conformity
with the acceptance criteria shall be maintained.
Records shall indicate the person(s) authorizing release of product for

delivery to the customer
The release of product and delivery of service shall not proceed until
the planned arrangements have been satisfactorily completed, unless
otherwise approved by a relevant authority, and where applicable by
the customer.

8.2.4 Monitoring and Measurement of Product
Measurementt requirements
M i t for
f Product
P d t or service
i acceptance
t shall
h ll
be documented. This documentation may be part of the Product
documentation, but shall include:
a) the criteria for acceptance and/or rejection,

b) where in the sequence measurement and testing operations are
performed,
c) a Record of the measurement results and
d) the type of measurement instruments required and any specific
instructions associated with their use.
Test Records shall show actual test results data when required
q byy
specification or acceptance test plan.

8.3ControlofNonconformingProduct
The organization shall ensure that product which does not conform to
product requirements is identified and controlled to prevent its unintended
use or delivery.
A documented procedure shall be established to define the controls and
related responsibilities and authorities for dealing with nonconforming
product.
Where applicable, the organization shall deal with nonconforming product by
one or more of the following
g ways:
y
a) By taking action to eliminate the detected nonconformity;
b) By authorizing its use, release or acceptance under concession by a
relevant authority and,
and where applicable,
applicable by the customer;
c) By taking action to preclude its original intended use or application.
d)) Byy taking
g action appropriate
pp p to the effects, or p
potential effects, of the of
the nonconformity when nonconforming product is detected after
delivery or use has started.
When nonconforming product is corrected it shall

be subject to re-verification to demonstrate
conformity
f it to
t the
th requirements.
i t
Records of the nature of nonconformities and anyy

subsequent actions taken, including concessions
obtained,, shall be maintained.

8.3.1 Control of nonconforming Process

Process to manage business management Process variation,
which
hi h includes:
i l d
a) identification, Recording and analyzing of the root causes of

the variation and if the business management Process is non
conform, taking appropriate action to correct the nonconforming
process,
b) evaluation
l i whether
h h the
h business
b i management Process
P
variation has resulted in Product nonconformity, and
c) identification and control of the nonconforming Product in
accordance with clause 8.3.

8.3.1 Customer Concession
The organization shall obtain a customer Concession or Deviation
Permit prior to further Processing, whenever the Product or
Production Process differs from what has been approved.
Penalties due to Concessions and Deviation Permits should be

collected analyzed and assigned to causers.
collected, causers
NOTE 1
Penalties due to Concessions and Deviation Permits may be considered
as part of Quality Deficiency Cost.

8.3.1 Customer Concession
The organization shall maintain a Record of the expiration date of such a
Concession and/or quantity authorized.
The organization
Th i ti shall
h ll also
l ensure compliance
li with
ith the
th original
i i l or
superseded specification when the authorization of the customer
Concession expires.
Material shipped, which is subject to such a Concession, shall be

appropriately identified. This applies equally to purchased Products.
The organization should define and implement a customer Concession

Process.
The organization shall ensure that Concessions requested by any

supplier are agreed before submission to the customer.
8.4AnalysisofData
The organization shall determine, collect and analyze appropriate

data to demonstrate the suitability and effectiveness of the QMS
and to evaluate where continual improvement of the
effectiveness of the QMS.
The analysis of data shall provide information relating to:
a) customer satisfaction
b) conformity to product requirements
c)) characteristics and trends of p processes and p products
including opportunities for preventive action , and
d) Suppliers

8.4AnalysisofData
In addition to ISO 9001:2008, the organization should

ensure that
th t a Process
P f the
for th analysis
l i off data
d t is
i in
i place
l
(see clause 8.2.2) and the performance of this Process
should be measured byy a KPI.
In addition to the ISO 9001:2008, the analysis of data shall

provide information relating to:
e) external incident reports associated with the

organization's
i ti ' Products
P d t and
d
f) Product Safety.

8.5Improvement
8.5.1ContinualImprovement
The organization shall continually improve the

effectiveness of the QMS through the use of the quality
policy, quality objectives, audit results, analysis of data,
corrective and preventive actions and management
review.
The organization should define and implement

improvement Processes,
Processes based on corrective and
preventive actions.
8.5Improvement
8.5.2CorrectiveAction
The organization shall take action to eliminate the cause of
nonconformities in order to prevent recurrence. Corrective actions shall
be appropriate to the effects of the nonconformities encountered.
A documented
d t d procedure
d f corrective
for ti action
ti shall
h ll be
b established
t bli h d to
t
define requirements for:
a)) reviewing
g nonconformities ((including
g customer complaints);
p )
b) determine the causes of nonconformities;
c) evaluating the need for action to ensure that nonconformities do not
recur;
d) determining and implementing the action needed;
e) records of the results
res lts of action taken ; and
f) reviewing the effectiveness of the corrective action taken.
8.5Improvement
8.5.2CorrectiveAction
In addition to the ISO 9001:2008 requirements, the
documented Procedure shall define requirements to:
g) document the effectiveness and close out of

Corrective action.
The organization should define and implement a

corrective action Process,
Process which is regularly reviewed in
a multidisciplinary assessment (see clause.

8.5Improvement
8.5.3PreventiveAction
The organization shall determine action to eliminate the causes of potential
nonconformities in order to prevent their occurrence. Preventive actions shall
be appropriate to the effects of the potential problems.
A documented procedure shall be established to define requirements for:

a) determining potential nonconformities and their causes;
b) evaluating the need for action to prevent occurrence of nonconformities
c) determining and implementing action needed,
d) records
d off results
lt off action
ti taken
t k , and
d
e) reviewing the effectiveness of the preventive action taken.
The organization should define and implement a preventive action

Process, which is regularly reviewed in a multidisciplinary assessment
IRISScopeof
Certification

IRISScopeof
Certification

IRISScopeof
Certification

Processes/Procedures
/KPI/Records

Processes/Procedures
/KPI/Records

AssessmentMethodologies

KnockOutQuestions

KnockOutQuestions
The fulfillment of the requirements associated to all applicable KO questions
is mandatoryy and is considered as a p
prerequisite
q for IRIS certification.
When only one KO requirement is not met during the readiness review, the
whole audit fails. If a client fails an audit due to not meeting a Knock-Out
requirement, the audit can be continued, if wished by the auditee, until
its scheduled end, but to become IRIS certified, the certification
P
Process shall
h ll begin
b i again
i starting
t ti with
ith a new requestt and
d followed
f ll d by
b
a full evaluation Process
The certification p
process has to start after a while with a new request
q
covering the full audit process again.
KO questions are not scored.
Some KO questions may be not applicable

KnockOutQuestions
During the audit a checklist with 259 questions has to be used.
The checklist includes 12 KnockKnock-OutOut questions, which leads to
a complete new begin of the certification process in case they
were not met. The other questions will be divided into closed
(yes/no) or open questions.
Questions, which were evaluated as insufficient, have to pass
an additional on-site audit.
Questions,
Questions which were partial fulfilled,fulfilled can be verified with
alternative methods concerning the effectiveness of their
corrective actions.
A company will ill be
b certified,
tifi d if allll relevant
l t KO-questions
KO ti were
positive responded, if all corrective actions were closed within
90 days and if All open and closed questions were responded
with
ith in
i minimum
i i 2 points
i t (fulfilled)
(f lfill d)


Iris Short FTQM

Transféré par

Informations du document

Titre original

Copyright

Formats disponibles

Partager ce document

Partager ou intégrer le document

Options de partage

Avez-vous trouvé ce document utile ?

Ce contenu est-il inapproprié ?

Droits d'auteur :

Formats disponibles

Iris Short FTQM

Transféré par

Droits d'auteur :

Formats disponibles

Fouryes TQM Consultants

AG-3, Second Floor, Shanthi Colony, Anna Nagar, Chennai-600040, India

IRIS Requirements including ISO 9001 Requirements

Copyright 2014. Fouryes TQM Consultants. All rights reserved

Copyright 2014. Fouryes TQM Consultants. All rights reserved

ISO 9000 Fundamentals of QMS and Specifies

ISO 9001 Requirements for a QMS

ISO 9004 Provides guidelines that consider

ISO 19011 Guidance on auditingg Q

Copyright 2014. Fouryes TQM Consultants. All rights reserved

2000: In Germany most of the railway equipment manufacturers

2000 2004: two different Working Groups set by Alstom and

April 2004: Alstom, Bombardier and Siemens started cooperation.

developed the name was changed into IRIS ( nternational I Railway

May 2005: UNIFE (Association of the European Rail Industry) General

July 2005: Constitution of IRIS Group with participation of system

May 2006: IRIS Rev00 was officially launched in Geneva.

November 2007: IRIS Rev01 was launched on the market (incl.

Copyright 2014. Fouryes TQM Consultants. All rights reserved

Copyright 2014. Fouryes TQM Consultants. All rights reserved

an international standard based on the principles of ISO 9001

an evaluation process with an assessment guideline to be

a web-based IRIS Portal (database) and Audit-Tool

Copyright 2014. Fouryes TQM Consultants. All rights reserved

Configuration management Human resources

Project management Infrastructure

3 Specific rules controlling:

Actors (CB global presence, railway experience, targets to

8 Clauses of ISO 9001 Requirements

Annex 1 - IRIS Scope of Certification

Annex 5 - Terms and definitions for the rail sector

Copyright 2014. Fouryes TQM Consultants. All rights reserved

Copyright 2014. Fouryes TQM Consultants. All rights reserved

This international standard can be used in by internal and

The Quality management Principles started in ISO 9001 and ISO

Copyright 2014. Fouryes TQM Consultants. All rights reserved

Copyright 2014. Fouryes TQM Consultants. All rights reserved

5. System Approach to Management

7. Factual Approach to Decision Making

8. Mutually Beneficial Supplier Relationships

Copyright 2014. Fouryes TQM Consultants. All rights reserved

0.2 Process Approach

Set of interrelated or interacting activities

Out puts from one process are typically inputs

Overall aim is to add value by planning and

Copyright 2014. Fouryes TQM Consultants. All rights reserved

Schematic Representation of a Process

Input Process Output

Copyright 2014. Fouryes TQM Consultants. All rights reserved

Copyright 2014. Fouryes TQM Consultants. All rights reserved

What is a Process Approach?

The systematic identification and management of the

Copyright 2014. Fouryes TQM Consultants. All rights reserved

Copyright 2014. Fouryes TQM Consultants. All rights reserved

0.3 Relationship with ISO 9004

0.4 Compatibility with other management system

Due consideration is given to the provisions of ISO 14001 to

Copyright 2014. Fouryes TQM Consultants. All rights reserved

Copyright 2014. Fouryes TQM Consultants. All rights reserved

0.5 Aim of IRIS Standard

Due to the importance of Project business in the rail sector, special

Whenever ISO 9001:2008 refers to Product or Product realization,

Copyright 2014. Fouryes TQM Consultants. All rights reserved