SIST EN ISO 22163:2024

SLOVENSKI STANDARD
01-julij-2024
Železniške naprave - Sistem vodenja kakovosti v železniškem prometu - ISO
9001:2015 in posebne zahteve za uporabo v železniškem sektorju (ISO 22163:2023)
Railway applications - Railway quality management system - ISO 9001:2015 and specific
requirements for application in the railway sector (ISO 22163:2023)
Bahnanwendungen - Eisenbahn-Qualitätsmanagementsystem - ISO 9001:2015 und
spezifische Anforderungen für die Anwendung im Bahnsektor (ISO 22163:2023)
Applications ferroviaires - Système de management de la qualité ferroviaire - Exigences
de l'ISO 9001:2015 et exigences particulières concernant les applications dans le
secteur ferroviaire (ISO 22163:2023)
Ta slovenski standard je istoveten z: EN ISO 22163:2024
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
45.020 Železniška tehnika na Railway engineering in
splošno general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 22163
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2024
EUROPÄISCHE NORM
ICS 03.100.70; 45.020
English Version
Railway applications - Railway quality management
system - ISO 9001:2015 and specific requirements for
application in the railway sector (ISO 22163:2023)
Applications ferroviaires - Système de management de Bahnanwendungen - Eisenbahn-
la qualité ferroviaire - Exigences de l'ISO 9001:2015 et Qualitätsmanagementsystem - ISO 9001:2015 und
exigences particulières concernant les applications spezifische Anforderungen für die Anwendung im
dans le secteur ferroviaire (ISO 22163:2023) Bahnsektor (ISO 22163:2023)
This European Standard was approved by CEN on 5 May 2024.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 22163:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO 22163:2023 has been prepared by Technical Committee ISO/TC 269 "Railway
applications” of the International Organization for Standardization (ISO) and has been taken over as
which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by November 2024, and conflicting national standards
shall be withdrawn at the latest by November 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards body.
A complete listing of these bodies can be found on the CEN website.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 22163:2023 has been approved by CEN as EN ISO 22163:2024 without any modification.

INTERNATIONAL ISO
STANDARD 22163
First edition
2023-07
Railway applications — Railway
quality management system — ISO
9001:2015 and specific requirements
for application in the railway sector
Applications ferroviaires — Système de management de la qualité
ferroviaire — Exigences de l'ISO 9001:2015 et exigences particulières
concernant les applications dans le secteur ferroviaire
Reference number
ISO 22163:2023(E)
ISO 22163:2023(E)
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
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ISO 22163:2023(E)
Contents Page
Foreword . vi
Introduction .viii
1 Scope . 1
1.1 Scope — Supplemental . 1
2 Normative references . 1
3 Terms, definitions and abbreviated terms . 1
3.1 Terms and definitions . 2
3.1.1 System . 2
3.1.2 Process . 3
3.1.3 Requirement . 7
3.1.4 Product and tools . 9
3.2 Abbreviated terms . 11
4 Context of the organization .12
4.1 Understanding the organization and its context .12
4.1.1 Understanding the organization and its context — Supplemental .12
4.1.2 Social responsibility .13
4.2 Understanding the needs and expectations of interested parties .13
4.3 Determining the scope of the quality management system .13
4.3.1 Determining the scope of the quality management system — Supplemental . 14
4.4 Quality management system and its processes . 14
4.4.3 Quality management system and its processes — Supplemental . 14
5 L eadership .15
5.1 L eadership and commitment . 15
5.1.1 General .15
5.1.2 Customer focus . 16
5.2 Policy . 16
5.2.1 Establishing the quality policy . 16
5.2.2 Communicating the quality policy . 16
5.2.3 Quality policy — Supplemental . 16
5.3 Organizational roles, responsibilities and authorities . 17
5.3.1 Organizational roles, responsibilities and authorities — Supplemental . 17
5.3.2 Responsibilities and authorities of process owners . 17
6 Pl a n n i n g .17
6.1 Actions to address risks and opportunities . 17
6.1.3 Actions to address risks and opportunities — Supplemental . 18
6.1.4 Business continuity . 18
6.2 Quality objectives and planning to achieve them. 19
6.3 P lanning of changes .20
7 Support .20
7.1 Resources . 20
7.1.1 General .20
7.1.2 People . 20
7.1.3 Infrastructure . 21
7.1.4 Environment for the operation of processes . 21
7.1.5 Monitoring and measuring resources . 21
7.1.6 Organizational knowledge . 22
7.2 Competence . 23
7.2.1 Competence — Supplemental . 24
7.3 Awareness . 24
7.4 Communication . 25
7.4.1 Communication — Supplemental . 25
7.5 Documented information . 25
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ISO 22163:2023(E)
7.5.1 General . 25
7.5.2 Creating and updating . 25
7.5.3 Control of documented information . 26
8 Operation .27
8.1 Operational planning and control . 27
8.1.1 Operational planning and control — Supplemental . 27
8.1.2 Tender management .28
8.1.3 Project management .28
8.1.4 Configuration management and change control . 33
8.2 Requirements for products and services . 35
8.2.1 Customer communication . 35
8.2.2 Determining the requirements related to products and services .36
8.2.3 Review of requirements related to products and services.36
8.2.4 Changes to requirements for products and services . 37
8.2.5 Requirements for products and services — Supplemental . 37
8.3 Design and development of products and services .38
8.3.1 General .38
8.3.2 Design and development planning .38
8.3.3 Design and development inputs .39
8.3.4 Design and development controls .40
8.3.5 Design and development outputs . 42
8.3.6 Design and development changes . 42
8.4 Control of externally provided processes, products and services . 43
8.4.1 General . 43
8.4.2 Type and extent of control . 45
8.4.3 Information for external providers . 47
8.4.4 Supply chain management .48
8.5 Production and service provision .49
8.5.1 Control of production and service provision .49
8.5.2 Identification and traceability . 53
8.5.3 Property belonging to customers or external providers .53
8.5.4 Preservation .54
8.5.5 Post-delivery activities .54
8.5.6 Control of changes . 55
8.6 Release of products and services . 55
8.6.1 Release of products and services — Supplemental .56
8.7 Control of nonconforming outputs .56
8.7.3 Control of nonconforming outputs — Supplemental . 57
8.8 Reliability, availability, maintainability, safety and life cycle costing . 57
8.8.1 General . 57
8.8.2 Reliability, availability and maintainability .58
8.8.3 Safety .58
8.8.4 Life cycle costing .58
8.9 First article inspection . 59
8.10 Obsolescence management . 59
9 P erformance evaluation .60
9.1 M onitoring, measurement, analysis and evaluation . .60
9.1.1 General .60
9.1.2 Customer satisfaction . 61
9.1.3 Analysis and evaluation . 62
9.2 I nternal audit .63
9.2.3 Internal audit — Supplemental .63
9.3 M anagement review .64
9.3.1 General .64
9.3.2 Management review inputs .65
9.3.3 Management review outputs .66
9.4 Process reviews .66
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ISO 22163:2023(E)
10 Improvement .67
10.1 General . 67
10.2 Nonconformity and corrective action . 67
10.2.3 Nonconformity and corrective action — Supplemental .68
10.3 C ontinual improvement .68
Annex A (informative) List of processes .69
Annex B (informative) Subordinate concept of requirements for products and services .71
Annex C (informative) Performance indicators .72
Bibliography .75
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ISO 22163:2023(E)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
through ISO technical committees. Each member body interested in a subject for which a technical
committee has been established has the right to be represented on that committee. International
organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.
ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO document should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use
of (a) patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed
patent rights in respect thereof. As of the date of publication of this document, ISO had not received
notice of (a) patent(s) which may be required to implement this document. However, implementers are
cautioned that this may not represent the latest information, which may be obtained from the patent
database available at www.iso.org/patents. ISO shall not be held responsible for identifying any or all
such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 269, Railway applications.
This first edition of ISO 22163 cancels and replaces ISO/TS 22163:2017.
The main changes are as follows:
— the scope has been simplified;
— the terms and definitions in Clause 3 have been revised;
— the previous subclause 6.4 “Business planning” has been moved to 4.1.1;
— a new subclause 4.1.2 on “Social responsibility” has been added;
— subclause 7.2.1 “Competence — Supplemental” has been revised;
— the previous subclause 8.11 “Innovation management” has been moved to 8.1.1.1;
— “Project review management” has been separated from the previous subclause 8.1.3.7 “Project
communications management” as a new subclause 8.1.3.11;
— the previous subclauses 8.1.4 “Configuration management” and 8.1.5 “Change management” have
been combined in 8.1.4 “Configuration management and change control”;
— product safety requirements have been integrated in the quality requirements;
— reliability, availability, maintainability, safety and life cycle costing requirements have been clarified
in 8.8;
— the notion of performance indicators versus key performance indicators has been added;
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ISO 22163:2023(E)
— the performance indicators have been revised;
— Annex A on “List of processes” has been added;
— Annex B on “Subordinate concept of requirements for products and services” has been added;
— Annex C on “Performance indicators” has been added.
Any feedback or questions on this document should be directed to the user's national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
vii
ISO 22163:2023(E)
Introduction
0.1  General
The aim of this document is to develop and continually improve a railway quality management system
to ensure product quality including safety in the global railway sector, in order to satisfy customer
needs.
This document adds the supplemental railway sector specific requirements to ISO 9001:2015.
The content inside the boxed text of this document is ISO 9001:2015 text.
Whenever the ISO 9001:2015 text in this document refers to “quality management system”, this term
is understood hereinafter as “railway quality management system”, not limited to quality, so that it
encompasses all railway quality processes of the organization. Therefore, in the supplemental railway
sector specific requirements, the term “railway quality management system” is used outside the boxed
text.
Whenever the ISO 9001:2015 text refers to “this International Standard”, this applies to this document,
including the text outside the boxes.
Whenever this document refers to clause numbers, it is to be understood that all the requirements
under this clause including subclauses are to be considered.
Whenever this document refers to “safety”, the term is to be understood as “safety of products and
services”, not to be confused with “occupational safety”.
Whenever this document requires a process, this process can be either
— defined within a single process,
— combined with another process or other processes, or
— split in several processes
according to the railway quality management system defined by the organization.
ISO 9001:2015, Quality management systems — Requirements
0.1  General
The adoption of a quality management system is a strategic decision for an organization that can help
to improve its overall performance and provide a sound basis for sustainable development initiatives.
The potential benefits to an organization of implementing a quality management system based on this
International Standard are:
a) the ability to consistently provide products and services that meet customer and applicable
statutory and regulatory requirements;
b) facilitating opportunities to enhance customer satisfaction;
c) addressing risks and opportunities associated with its context and objectives;
d) the ability to demonstrate conformity to specified quality management system requirements.
This International Standard can be used by internal and external parties.
It is not the intent of this International Standard to imply the need for:
— uniformity in the structure of different quality management systems;
— alignment of documentation to the clause structure of this International Standard;
— the use of the specific terminology of this International Standard within the organization.
The quality management system requirements specified in this International Standard are complemen-
tary to requirements for products and services.
viii
ISO 22163:2023(E)
This International Standard employs the process approach, which incorporates the Plan-Do-Check-Act
(PDCA) cycle and risk-based thinking.
The process approach enables an organization to plan its processes and their interactions.
The PDCA cycle enables an organization to ensure that its processes are adequately resourced and
managed, and that opportunities for improvement are determined and acted on.
Risk-based thinking enables an organization to determine the factors that could cause its processes and
its quality management system to deviate from the planned results, to put in place preventive controls
to minimize negative effects and to make maximum use of opportunities as they arise.
Consistently meeting requirements and addressing future needs and expectations poses a challenge
for organizations in an increasingly dynamic and complex environment. To achieve this objective, the
organization might find it necessary to adopt various forms of improvement in addition to correction
and continual improvement, such as breakthrough change, innovation and re-organization.
In this International Standard, the following verbal forms are used:
— “shall” indicates a requirement;
— “should” indicates a recommendation;
— “may” indicates a permission;
— “can” indicates a possibility or a capability.
Information marked as “NOTE” is for guidance in understanding or clarifying the associated requirement.
0.2  Quality management principles
ISO 9001:2015, Quality management systems — Requirements
0.2  Quality management principles
This International Standard is based on the quality management principles described in ISO 9000. The
descriptions include a statement of each principle, a rationale of why the principle is important for the
organization, some examples of benefits associated with the principle and examples of typical actions
to improve the organization's performance when applying the principle.
The quality management principles are:
— customer focus;
— leadership;
— engagement of people;
— process approach;
— improvement;
— evidence-based decision making;
— relationship management.
0.3  Process approach
0.3.1  General
ISO 9001:2015, Quality management systems — Requirements
0.3  Process approach
0.3.1  General
This International Standard promotes the adoption of a process approach when developing, implement-
ing and improving the effectiveness of a quality management system, to enhance customer satisfaction
by meeting customer requirements. Specific requirements considered essential to the adoption of a
process approach are included in 4.4.
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ISO 22163:2023(E)
Understanding and managing interrelated processes as a system contributes to the organization's
effectiveness and efficiency in achieving its intended results. This approach enables the organization
to control the interrelationships and interdependencies among the processes of the system, so that the
overall performance of the organization can be enhanced.
The process approach involves the systematic definition and management of processes, and their
interactions, so as to achieve the intended results in accordance with the quality policy and strategic
direction of the organization. Management of the processes and the system as a whole can be achieved
using the PDCA cycle (see 0.3.2) with an overall focus on risk-based thinking (see 0.3.3) aimed at taking
advantage of opportunities and preventing undesirable results.
The application of the process approach in a quality management system enables:
a) understanding and consistency in meeting requirements;
b) the consideration of processes in terms of added value;
c) the achievement of effective process performance;
d) improvement of processes based on evaluation of data and information.
Figure 1 gives a schematic representation of any process and shows the interaction of its elements. The
monitoring and measuring check points, which are necessary for control, are specific to each process
and will vary depending on the related risks.

Figure 1 — Schematic representation of the elements of a single process
0.3.2  Plan-Do-Check-Act cycle
ISO 9001:2015, Quality management systems — Requirements
0.3.2  Plan-Do-Check-Act cycle
The PDCA cycle can be applied to all processes and to the quality management system as a whole. Fig-
ure 2 illustrates how Clauses 4 to 10 can be grouped in relation to the PDCA cycle.
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ISO 22163:2023(E)
NOTE Numbers in brackets refer to the clauses in this International Standard.
Figure 2 — Representation of the structure of this International Standard in the PDCA cycle
The PDCA cycle can be briefly described as follows:
— Plan: establish the objectives of the system and its processes, and the resources needed to deliver
results in accordance with customers' requirements and the organization's policies, and identify
and address risks and opportunities;
— Do: implement what was planned;
— Check: monitor and (where applicable) measure processes and the resulting products and services
against policies, objectives, requirements and planned activities, and report the results;
— Act: take actions to improve performance, as necessary.
0.3.3  Risk-based thinking
ISO 9001:2015, Quality management systems — Requirements
0.3.3  Risk-based thinking
Risk-based thinking is essential for achieving an effective quality management system. The concept of
risk-based thinking has been implicit in previous editions of this International Standard including, for
example, carrying out preventive action to eliminate potential nonconformities, analysing any noncon-
formities that do occur, and taking action to prevent recurrence that is appropriate for the effects of
the nonconformity.
To conform to the requirements of this International Standard, an organization needs to plan and imple-
ment actions to address risks and opportunities. Addressing both risks and opportunities establishes
a basis for increasing the effectiveness of the quality management system, achieving improved results
and preventing negative effects.
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ISO 22163:2023(E)
Opportunities can arise as a result of a situation favourable to achieving an intended result, for ex-
ample, a set of circumstances that allow the organization to attract customers, develop new products
and services, reduce waste or improve productivity. Actions to address opportunities can also include
consideration of associated risks. Risk is the effect of uncertainty and any such uncertainty can have
positive or negative effects. A positive deviation arising from a risk can provide an opportunity, but not
all positive effects of risk result in opportunities.
0.4  Relationship with other management system standards
ISO 9001:2015, Quality management systems — Requirements
0.4  Relationship with other management system standards
This International Standard applies the framework developed by ISO to improve alignment among its
International Standards for management systems.
This International Standard enables an organization to use the process approach, coupled with the PDCA
cycle and risk-based thinking, to align or integrate its quality management system with the requirements
of other management system standards.
This International Standard relates to ISO 9000 and ISO 9004 as follows:
— ISO 9000 Quality management systems — Fundamentals and vocabulary provides essential
background for the proper understanding and implementation of this International Standard;
— ISO 9004 Managing for the sustained success of an organization — A quality management approach
provides guidance for organizations that choose to progress beyond the requirements of this
International Standard.
This International Standard does not include requirements specific to other management systems,
such as those for environmental management, occupational health and safety management, or financial
management.
Sector-specific quality management system standards based on the requirements of this International
Standard have been developed for a number of sectors. Some of these standards specify additional quality
management system requirements, while others are limited to providing guidance to the application of
this International Standard within the particular sector.
A matrix showing the correlation between the clauses of this edition of this International Standard
and the previous edition (ISO 9001:2008) can be found on the ISO/TC 176/SC 2 open access website at:
https://www.iso.org/tc176/sc02/public.
xii
INTERNATIONAL STANDARD ISO 22163:2023(E)
Railway applications — Railway quality management
system — ISO 9001:2015 and specific requirements for
application in the railway sector
1 Scope
ISO 9001:2015, Quality management systems — Requirements
1  Scope
This International Standard specifies requirements for a quality management system when an organ-
ization:
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.
All the requirements of this International Standard are generic and are intended to be applicable to any
organization, regardless of its type or size, or the products and services it provides.
NOTE 1 In this International Standard, the terms “product” or “service” only apply to products and services
intended for, or required by, a customer.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements.
1.1 Scope — Supplemental
This document specifies the requirements for a railway quality management system (RQMS)
— applicable throughou
...