CEN ISO/TS 23406:2021

SLOVENSKI STANDARD
01-december-2021
Jedrski sektor - Zahteve za organe, ki presojajo in certificirajo sisteme vodenja
kakovosti za organizacije, ki dobavljajo izdelke in storitve, pomembne za jedrsko
varnost (ITNS) (ISO/TS 23406:2020)
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 23406:2020)
Nuklearsektor - Anforderungen an Stellen, die Qualitätsmanagementsysteme für
Organisationen, die für die nukleare Sicherheit wichtige Produkte und Dienstleistungen
liefern, prüfen und zertifizieren (ITNS) (ISO/TS 23406:2020)
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 23406:2020)
Ta slovenski standard je istoveten z: CEN ISO/TS 23406:2021
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
October 2021
TECHNISCHE SPEZIFIKATION
ICS 03.120.20; 27.120.01
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 23406:2020)
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, die
management de la qualité d'organisations fournissant für die nukleare Sicherheit wichtige Produkte und
des produits et services importants pour la sûreté Dienstleistungen liefern, prüfen und zertifizieren
nucléaire (IPSN) (ISO/TS 23406:2020) (ITNS) (ISO/TS 23406:2020)
This Technical Specification (CEN/TS) was approved by CEN on 3 October 2021 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, Turkey 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
© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TS 23406:2021 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
The text of ISO/TS 23406:2020 has been prepared by Technical Committee ISO/TC 85 "Nuclear energy,
nuclear technologies, and radiological protection” of the International Organization for Standardization
(ISO) and has been taken over as CEN ISO/TS 23406:2021 by 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.
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 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, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO/TS 23406:2020 has been approved by CEN as CEN ISO/TS 23406:2021 without any
modification.
TECHNICAL ISO/TS
SPECIFICATION 23406
First edition
2020-01
Nuclear sector — Requirements
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 23406:2020(E)
©
ISO 2020
ISO/TS 23406:2020(E)
© ISO 2020
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
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Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2020 – All rights reserved

ISO/TS 23406:2020(E)
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 . 1
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 advisors . 3
7.4 Personnel records. 3
7.5 Outsourcing. 3
8 Information requirements . 3
8.1 Public information . 3
8.2 Certification documents . 3
8.3 Reference to certification and marks . 3
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 Multisite sampling . 5
9.1.6 Multiple management systems standards . 6
9.2 Planning audits . 6
9.3 Initial certification . 6
9.4 Conducting audits . 6
9.5 Certification decision . 7
9.6 Maintaining certification . 7
9.7 Appeals . 7
9.8 Complaints . 7
9.9 Client records . 8
10 Management system requirements for certification bodies . 8
Annex A (normative) Competence criteria . 9
Annex B (informative) Summary of audit results.14
Annex C (normative) Eligibility criteria for multi-site sampling .15
ISO/TS 23406:2020(E)
Bibliography .16
iv © ISO 2020 – All rights reserved

ISO/TS 23406:2020(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 documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www. iso. org/d irectives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www. iso. org/p atents).
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.
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/m embers. html.
ISO/TS 23406:2020(E)
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 © ISO 2020 – All rights reserved

TECHNICAL SPECIFICATION ISO/TS 23406:2020(E)
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 is recommended for use 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, 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.
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.
5.2 Management of impartiality
The requirements of ISO/IEC 17021-1:2015, 5.2, apply.
ISO/TS 23406:2020(E)
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, 6.2.1 and 6.2.2, 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 standard 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 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
...