CEN ISO/TS 23406:2024
(Main)Nuclear sector - Requirements for bodies providing audit and certification of quality management systems for organizations supplying products and services important to nuclear safety (ITNS) (ISO/TS 23406:2024, Corrected version 2025-07)
Nuclear sector - Requirements for bodies providing audit and certification of quality management systems for organizations supplying products and services important to nuclear safety (ITNS) (ISO/TS 23406:2024, Corrected version 2025-07)
This document complements the existing requirements of ISO/IEC 17021-1 for bodies providing audit and certification of quality management systems against ISO 19443.
NOTE This document can be used as a criteria document for accreditation, peer assessment or other audit processes.
Nuklearsektor - Anforderungen an Stellen, die Qualitätsmanagementsysteme für Organisationen prüfen und zertifizieren, die für die nukleare Sicherheit wichtige Produkte und Dienstleistungen (ITNS) liefern (ISO/TS 23406:2023, korrigierte Fassung 2025-07)
Dieses Dokument ergänzt die bestehenden Anforderungen nach ISO/IEC 17021 1 an Stellen, die Qualitätsmanagementsysteme gegen ISO 19443 auditieren und zertifizieren.
ANMERKUNG Dieses Dokument kann als Vorgabe für die Akkreditierung, Begutachtung unter Gleichrangigen oder für andere Auditprozesse genutzt werden.
Secteur nucléaire - Exigences pour les organismes procédant à l'audit et à la certification des systèmes de management de la qualité d'organisations fournissant des produits et services importants pour la sûreté nucléaire (IPSN) (ISO/TS 23406:2024, Version corrigée 2025-07)
Le présent document vient compléter les exigences existantes de l'ISO/IEC 17021-1 pour les organismes procédant à l'audit et à la certification des systèmes de management de la qualité selon l'ISO 19443.
NOTE Le présent document peut être utilisé comme référentiel pour l'accréditation, l'évaluation par des pairs ou d'autres processus d'audit.
Jedrski sektor - Zahteve za organe, ki izvajajo presojo in certificiranje sistemov vodenja kakovosti za organizacije, ki dobavljajo proizvode in storitve, pomembne za jedrsko varnost (ITNS) (ISO/TS 23406:2023)
Ta dokument dopolnjuje obstoječe zahteve standarda ISO/IEC 17021-1 za organe, ki izvajajo presojo in certificiranje sistemov vodenja kakovosti v skladu s standardom ISO 19443.
OPOMBA: Ta dokument je priporočljivo uporabljati kot dokument z merili za akreditacijo, medsebojno ocenjevanje ali druge procese presojanja.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
Jedrski sektor - Zahteve za organe, ki izvajajo presojo in certificiranje sistemov
vodenja kakovosti za organizacije, ki dobavljajo proizvode in storitve, pomembne
za jedrsko varnost (ITNS) (ISO/TS 23406:2023)
Nuclear sector - Requirements for bodies providing audit and certification of quality
management systems for organizations supplying products and services important to
nuclear safety (ITNS) (ISO/TS 23406:2024)
Nuklearsektor - Anforderungen an Stellen, die Qualitätsmanagementsysteme für
Organisationen prüfen und zertifizieren, die für die nukleare Sicherheit wichtige Produkte
und Dienstleistungen (ITNS) liefern (ISO/DTS 23406:2023)
Secteur nucléaire - Exigences pour les organismes procédant à l'audit et à la certification
des systèmes de management de la qualité d'organisations fournissant des produits et
services importants pour la sûreté nucléaire (IPSN) (ISO/TS 23406:2024)
Ta slovenski standard je istoveten z: CEN ISO/TS 23406:2024
ICS:
03.120.20 Certificiranje proizvodov in Product and company
podjetij. Ugotavljanje certification. Conformity
skladnosti assessment
27.120.01 Jedrska energija na splošno Nuclear energy in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
CEN ISO/TS 23406
TECHNICAL SPECIFICATION
SPÉCIFICATION TECHNIQUE
April 2024
TECHNISCHE SPEZIFIKATION
ICS 03.120.20; 27.120.01 Supersedes CEN ISO/TS 23406:2021
English Version
Nuclear sector - Requirements for bodies providing audit
and certification of quality management systems for
organizations supplying products and services important
to nuclear safety (ITNS) (ISO/TS 23406:2024)
Secteur nucléaire - Exigences pour les organismes Nuklearsektor - Anforderungen an Stellen, die
procédant à l'audit et à la certification des systèmes de Qualitätsmanagementsysteme für Organisationen
management de la qualité d'organisations fournissant prüfen und zertifizieren, die für die nukleare Sicherheit
des produits et services importants pour la sûreté wichtige Produkte und Dienstleistungen (ITNS) liefern
nucléaire (IPSN) (ISO/TS 23406:2024) (ISO/DTS 23406:2023)
This Technical Specification (CEN/TS) was approved by CEN on 5 April 2024 for provisional application.
The period of validity of this CEN/TS is limited initially to three years. After two years the members of CEN will be requested to
submit their comments, particularly on the question whether the CEN/TS can be converted into a European Standard.
CEN members are required to announce the existence of this CEN/TS in the same way as for an EN and to make the CEN/TS
available promptly at national level in an appropriate form. It is permissible to keep conflicting national standards in force (in
parallel to the CEN/TS) until the final decision about the possible conversion of the CEN/TS into an EN is reached.
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. CEN ISO/TS 23406:2024 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (CEN ISO/TS 23406:2024) has been prepared by Technical Committee ISO/TC 85
"Nuclear energy, nuclear technologies, and radiological protection" in collaboration with Technical
Committee CEN/TC 430 “Nuclear energy, nuclear technologies, and radiological protection” the
secretariat of which is held by AFNOR.
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.
This document supersedes CEN ISO/TS 23406:2021.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. 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 announce this Technical Specification: 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/TS 23406:2024 has been approved by CEN as CEN ISO/TS 23406:2024 without any
modification.
Technical
Specification
ISO/TS 23406
Second edition
Nuclear sector — Requirements
2024-03
for bodies providing audit and
certification of quality management
systems for organizations supplying
products and services important to
nuclear safety (ITNS)
Secteur nucléaire — Exigences pour les organismes procédant
à l'audit et à la certification des systèmes de management de
la qualité d'organisations fournissant des produits et services
importants pour la sûreté nucléaire (IPSN)
Reference number
ISO/TS 23406:2024(en) © ISO 2024
ISO/TS 23406:2024(en)
© ISO 2024
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
ii
ISO/TS 23406:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Principles . 1
5 General requirements . 1
5.1 Legal and contractual matters .1
5.2 Management of impartiality .2
5.3 Liability and financing .2
6 Structural requirements . 2
6.1 Organizational structure and top management .2
6.2 Operational control .2
7 Resource requirements . 2
7.1 Competence of personnel .2
7.1.1 General considerations .2
7.1.2 Determination of competence criteria.2
7.1.3 Evaluation processes .2
7.1.4 Other considerations .3
7.2 Personnel involved in the certification activities .3
7.3 Use of individual external auditors and external technical experts .3
7.4 Personnel records .3
7.5 Outsourcing .3
8 Information requirements . 3
8.1 Public information . .3
8.2 Certification documents .4
8.3 Reference to certification and marks .4
8.4 Confidentiality .4
8.5 Information exchange between a certification body and its client .4
9 Process requirements . 4
9.1 Pre-certification activities .4
9.1.1 Application .4
9.1.2 Application review . .4
9.1.3 Audit programme .4
9.1.4 Determining audit time .4
9.1.5 Multi-site sampling . .6
9.1.6 Multiple management systems standards . .7
9.1.7 Organization that does not supply ITNS products and services at the time of the
initial certification audit .7
9.2 Planning audits .7
9.3 Initial certification .7
9.4 Conducting audits .7
9.5 Certification decision . . .8
9.6 Maintaining certification .8
9.7 Appeals .9
9.8 Complaints.9
9.9 Client records .9
10 Management system requirements for certification bodies . 9
Annex A (normative) Required knowledge and skills to determine competence .10
Annex B (informative) Summary of audit results .15
iii
ISO/TS 23406:2024(en)
Annex C (normative) Eligibility criteria for multi-site sampling .16
Bibliography . 17
iv
ISO/TS 23406:2024(en)
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 85, Nuclear energy, nuclear technologies and
radiological protection, in collaboration with ISO Committee on Conformity Assessment (CASCO), and in
collaboration with the European Committee for Standardization (CEN) Technical Committee CEN/TC 430,
Nuclear energy, nuclear technologies, and radiological protection, in accordance with the Agreement on
technical cooperation between ISO and CEN (Vienna Agreement).
This second edition cancels and replaces the first edition (ISO/TS 23406:2020), which has been technically
revised.
The main changes are as follows:
— clarification on the multiple site organization audit duration.
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.
v
ISO/TS 23406:2024(en)
Introduction
Certification of the quality management system (QMS) of an organization supplying products and
services important to nuclear safety (ITNS) is one means of providing assurance that the organization has
implemented a system for the management of quality in line with its policy.
Supplementing ISO/IEC 17021-1 requirements, this document has been developed for the nuclear sector to
assist in the conformity assessment and certification according to ISO 19443.
vi
Technical Specification ISO/TS 23406:2024(en)
Nuclear sector — Requirements for bodies providing
audit and certification of quality management systems for
organizations supplying products and services important to
nuclear safety (ITNS)
1 Scope
This document complements the existing requirements of ISO/IEC 17021-1 for bodies providing audit and
certification of quality management systems against ISO 19443.
NOTE This document can be used as a criteria document for accreditation, peer assessment or other audit
processes.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes
requirements of this document. For dated references, only the edition cited applies. For undated references,
the latest edition of the referenced document (including any amendments) applies.
ISO 9000, Quality management systems — Fundamentals and vocabulary
ISO/IEC 17000, Conformity assessment — Vocabulary and general principles
ISO/IEC 17021-1:2015, Conformity assessment — Requirements for bodies providing audit and certification of
management systems — Part 1: Requirements
ISO 19443, Quality management systems — Specific requirements for the application of ISO 9001:2015 by
organizations in the supply chain of the nuclear energy sector supplying products and services important to
nuclear safety (ITNS)
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 9000, ISO/IEC 17000,
ISO/IEC 17021-1 and ISO 19443 apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
4 Principles
The principles of ISO/IEC 17021-1:2015, Clause 4, apply.
5 General requirements
5.1 Legal and contractual matters
The requirements of ISO/IEC 17021-1:2015, 5.1, apply and 5.1.2 is complemented as follows.
ISO/TS 23406:2024(en)
The certification agreement shall include provision that the certification body is informed by the client of
any starting, interruption or resumption of all activities on ITNS products or services.
5.2 Management of impartiality
The requirements of ISO/IEC 17021-1:2015, 5.2, apply.
5.3 Liability and financing
The requirements of ISO/IEC 17021-1:2015, 5.3, apply.
6 Structural requirements
6.1 Organizational structure and top management
The requirements of ISO/IEC 17021-1:2015, 6.1, apply.
6.2 Operational control
The requirements of ISO/IEC 17021-1:2015, 6.2 apply and 6.2.2 is complemented as follows.
The certification body shall identify a single office location and appoint an employee of this office that has
overall responsibility and authority for the implementation of this document by all its relevant locations.
7 Resource requirements
7.1 Competence of personnel
7.1.1 General considerations
The requirements of ISO/IEC 17021-1:2015, 7.1.1, apply.
7.1.2 Determination of competence criteria
The requirements of ISO/IEC 17021-1:2015, 7.1.2, apply, and ISO/IEC 17021-1:2015, Annex A, is complemented
by Annex A of this document.
7.1.3 Evaluation processes
The requirements of ISO/IEC 17021-1:2015, 7.1.3, apply and are complemented as follows.
— Satisfactory evaluation of auditor competence shall result in a documented auditor qualification.
— The initial qualification shall be based on requirements given in Annex A and is valid for 3 years.
Qualification renewal for a 3-year period shall be based on demonstration of:
— performance of at least 6 ISO 19443 certification, recertification or surveillance audits in 3 years with a
minimum of 20 days of audit,
— maintenance of professional knowledge related to codes, standards, procedures, instructions, and other
documents related to quality management systems in nuclear industry,
— participation in mandatory trainings,
— satisfactory supervision of the auditor performed during an ISO 19443 audit,
— absence of significant or recurrent complaint related to his auditing activities.
ISO/TS 23406:2024(en)
At any time, the certification body shall consider taking appropriate action, such as: training, withdrawing
or suspending auditor qualification, in case of:
— no auditing activity during more than one year,
— after a non-satisfactory supervised audit and/or examination of an audit report (e.g. by the certification
body or by an accreditation body),
— following a client’s significant complaint concerning the auditing activity,
— on request of the auditor’s management.
7.1.4 Other considerations
The requirements of ISO/IEC 17021-1:2015, 7.1.4, apply.
7.2 Personnel involved in the certification activities
The requirements of ISO/IEC 17021-1:2015, 7.2, apply and 7.2.8 is complemented as follow.
The certification body shall have at least one person with nuclear industry knowledge involved in the
certification decisions.
The minimum nuclear industry knowledge required for this role shall encompass: ISO/IEC 17021-1,
ISO 19443 and sufficient nuclear industry experience to understand the sector specificities and assess the
contents of the certification audit report and the relevance of its conclusions.
7.3 Use of individual external auditors and external technical experts
The requirements of ISO/IEC 17021-1:2015, 7.3, apply.
7.4 Personnel records
The requirements of ISO/IEC 17021-1:2015, 7.4, apply.
These requirements shall also apply to in
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