EN ISO 22163:2024

Railway applications - Railway quality management system - ISO 9001:2015 and specific requirements for application in the railway sector (ISO 22163:2023)

This document specifies requirements for a quality management system when an organization:
a)    needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and
b)    aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
All the requirements of this document 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 document, 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.
This document specifies the requirements for a railway quality management system (RQMS)
—    applicable throughout the whole supply chain of the railway sector related to industrial products and services,
—    providing continual improvement, emphasizing defect prevention and defect reduction in the supply chain, and
—    enhancing and sustaining product quality, including its safety aspects.

Bahnanwendungen - Eisenbahn-Qualitätsmanagementsystem - ISO 9001:2015 und spezifische Anforderungen für die Anwendung im Bahnsektor (ISO 22163:2023)

ISO 9001:2015, Qualitätsmanagementsysteme — Anforderungen
1   Anwendungsbereich
Diese Internationale Norm legt Anforderungen an ein Qualitätsmanagementsystem fest, wenn eine Organisation:
a)   ihre Fähigkeit darlegen muss, beständig Produkte und Dienstleistungen bereitstellen zu können, die die Anforderungen der Kunden und die zutreffenden gesetzlichen und behördlichen Anforderungen erfüllen, und
b)   danach strebt, die Kundenzufriedenheit durch wirksame Anwendung des Systems zu erhöhen, ein-schließlich der Prozesse zur Verbesserung des Systems und der Zusicherung der Einhaltung von Anforderungen der Kunden und von zutreffenden gesetzlichen und behördlichen Anforderungen.
Alle in dieser Internationalen Norm festgelegten Anforderungen sind allgemeiner Natur und auf jede Organisation zutreffend, unabhängig von deren Art oder Größe oder von der Art der von ihr bereitgestellten Produkte und Dienstleistungen.
ANMERKUNG 1   In dieser Internationalen Norm bezieht sich die Benennung „Produkt“ bzw. „Dienstleistung“ nur auf solche Produkte und Dienstleistungen, die für einen Kunden vorgesehen sind oder von diesem gefordert werden.
ANMERKUNG 2   Gesetzliche und behördliche Anforderungen können auch als rechtliche Anforderungen bezeichnet werden.
1.1   Anwendungsbereich — Ergänzendes
Dieses Dokument legt die Anforderungen an ein Eisenbahn-Qualitätsmanagementsystem (en: railway quality management system, RQMS) fest,
-   die über die gesamte Lieferkette des Eisenbahnsektors in Bezug auf industrielle Produkte und Dienstleistungen gelten,
-   die eine fortlaufende Verbesserung vorsehen, unter Betonung von Fehlervermeidung und -reduzierung in der Lieferkette,
-   die die Produktqualität, einschließlich deren Sicherheitsaspekte, verbessern und erhalten.

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)

Le présent document spécifie les exigences relatives au système de management de la qualité lorsqu'un organisme:
a)    doit démontrer son aptitude à fournir constamment des produits et des services conformes aux exigences des clients et aux exigences légales et réglementaires applicables, et
b)    vise à accroître la satisfaction de ses clients par l'application efficace du système, y compris les processus pour l'amélioration du système et l'assurance de la conformité aux exigences des clients et aux exigences légales et réglementaires applicables.
Toutes les exigences de ce présent document sont génériques et prévues pour s'appliquer à tout organisme, quels que soient son type ou sa taille, ou les produits et services qu'il fournit.
NOTE 1    Dans ce présent document, les termes «produit» ou «service» s'appliquent uniquement aux produits et services destinés à, ou exigés par, un client.
NOTE 2    L'expression «legal requirement» recouvre en anglais le concept, utilisé dans ce présent document, d'exigence légale et réglementaire.
Le présent document spécifie les exigences d'un système de management de la qualité ferroviaire (SMQF):
—    applicables tout au long de la chaîne logistique du secteur ferroviaire et relatives aux produits et services industriels,
—    assurant l'amélioration continue et renforçant la prévention et la réduction des défaillances dans la chaîne d’approvisionnement, et
—    améliorant durablement la qualité des produits, y compris en matière de sécurité.

Železniške naprave - Sistem vodenja kakovosti v železniškem prometu - ISO 9001:2015 in posebne zahteve za uporabo v železniškem sektorju (ISO 22163:2023)

Ta dokument določa zahteve za sistem vodenja kakovosti. Uporablja se, kadar organizacija:
a)    dokazuje svojo sposobnost, da dosledno dobavlja izdelke in storitve, ki izpolnjujejo zahteve odjemalcev ter ustrezne zakonodajne in regulativne zahteve, ter
b)    namerava izboljšati zadovoljstvo odjemalcev z učinkovito uporabo sistema, vključno s procesi za izboljševanje sistema in zagotavljanje skladnosti z zahtevami odjemalcev ter z ustreznimi zakonodajnimi in regulativnimi zahtevami.
Vse zahteve v tem dokumentu so splošne in namenjene za uporabo v vseh organizacijah, ne glede na vrsto in velikost ali izdelke in storitve, ki jih zagotavljajo.
OPOMBA 1:    Izraza »izdelek« in »storitev« se v tem dokumentu navezujeta samo na izdelke in storitve, ki so namenjeni odjemalcu ali jih ta zahteva.
OPOMBA 2:    Zakonske in regulativne zahteve so lahko izražene kot pravne zahteve.
Ta dokument določa zahteve za sistem vodenja kakovosti v železniškem prometu (RQMS), ki:
–    se uporablja v celotni dobavni verigi železniškega sektorja v povezavi z industrijskimi izdelki in storitvami;
–    omogoča nenehno izboljševanje, s poudarkom na preprečevanju in zmanjševanju napak v dobavni verigi; ter
–    izboljšuje in ohranja kakovost izdelkov, vključno z varnostnimi vidiki.

General Information

• Status: Published
• Publication Date: 07-May-2024
• ICS: 03.100.70 - Management systems
• ICS: 45.020 - Railway engineering in general
• Technical Committee: CEN/TC 256 - Railway applications
• Drafting Committee: CEN/TC 256/WG 57 - Adoption of ISO Standards
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 08-May-2024
• Due Date: 27-Feb-2026
• Completion Date: 08-May-2024
• Ref Project: SIST EN ISO 22163:2024 - Railway applications - Railway quality management system - ISO 9001:2015 and specific requirements for application in the railway sector (ISO 22163:2023)

Relations

• Amended By: EN ISO 22163:2024/prA1 - Railway applications - Railway quality management system - ISO 9001:2015 and specific requirements for application in the railway sector - Amendment 1: Climate action changes (ISO 22163:2023/Amd 1:2024)
• Effective Date: 26-Jun-2024

Standards Content (Sample)

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: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
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 .
...