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)

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.

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)

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)

General Information

Status
Published
Public Enquiry End Date
01-Sep-2021
Publication Date
14-Oct-2021
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
13-Oct-2021
Due Date
18-Dec-2021
Completion Date
15-Oct-2021

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SLOVENSKI STANDARD
kSIST-TS FprCEN ISO/TS 23406:2021
01-september-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: FprCEN ISO/TS 23406
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
kSIST-TS FprCEN ISO/TS 23406:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
kSIST-TS FprCEN ISO/TS 23406:2021
---------------------- Page: 2 ----------------------
kSIST-TS FprCEN ISO/TS 23406:2021
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
---------------------- Page: 3 ----------------------
kSIST-TS FprCEN ISO/TS 23406:2021
ISO/TS 23406:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© 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

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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
kSIST-TS FprCEN ISO/TS 23406:2021
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 2020 – All rights reserved iii
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kSIST-TS FprCEN ISO/TS 23406:2021
ISO/TS 23406:2020(E)

Bibliography .............................................................................................................................................................................................................................16

iv © ISO 2020 – All rights reserved
---------------------- Page: 6 ----------------------
kSIST-TS FprCEN ISO/TS 23406:2021
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 2020 – All rights reserved v
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kSIST-TS FprCEN ISO/TS 23406:2021
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
---------------------- Page: 8 ----------------------
kSIST-TS FprCEN ISO/TS 23406:2021
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 2020 – All rights reserved 1
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kSIST-TS FprCEN ISO/TS 23406:2021
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,
— participation in mandatory trainings,
— satisfactory supervision of the Auditor,

— absence of significant or recurrent complaint related to his auditing activities.

At any time, the CB shall:
— in case of no auditing activity during more than one year,

— after a non-satisfactory supervision and/or examination of an audit report (internal to the

Certification Body or by accreditation body),
2 © ISO 2020 – All rights reserved
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kSIST-TS FprCEN ISO/TS 23406:2021
ISO/TS 23406:2020(E)
— following a client’s significant complaint concerning the auditing activity,
— on request of the Auditor’s management,

consider taking appropriate action, such as: training, withdrawing or suspending auditor qualification.

The CB shall identify the appropriate criteria and relevant process in their management system.

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 follows:

The certification body's certification function shall have at least one person(s) 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 advisors
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 individual external auditors and external technical advisors.

7.5 Outsourcing

The requirements of ISO/IEC 17021-1:2015, 7.5 are complemented by the following requirement:

The Certification shall maintain the responsibility for all functions in Table A.1 and shall not transfer

the responsibility to any other organization.

This doesn’t preclude the Certification Body’s use of organization or individuals which o

...

SLOVENSKI STANDARD
SIST-TS CEN ISO/TS 23406:2021
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
SIST-TS CEN ISO/TS 23406:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST-TS CEN ISO/TS 23406:2021
---------------------- Page: 2 ----------------------
SIST-TS CEN ISO/TS 23406:2021
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.
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SIST-TS CEN ISO/TS 23406:2021
CEN ISO/TS 23406:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST-TS CEN ISO/TS 23406:2021
CEN ISO/TS 23406:2021 (E)
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.
---------------------- Page: 5 ----------------------
SIST-TS CEN ISO/TS 23406:2021
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SIST-TS CEN ISO/TS 23406:2021
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
---------------------- Page: 7 ----------------------
SIST-TS CEN ISO/TS 23406:2021
ISO/TS 23406:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© 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

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
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST-TS CEN ISO/TS 23406:2021
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 2020 – All rights reserved iii
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SIST-TS CEN ISO/TS 23406:2021
ISO/TS 23406:2020(E)

Bibliography .............................................................................................................................................................................................................................16

iv © ISO 2020 – All rights reserved
---------------------- Page: 10 ----------------------
SIST-TS CEN ISO/TS 23406:2021
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 2020 – All rights reserved v
---------------------- Page: 11 ----------------------
SIST-TS CEN ISO/TS 23406:2021
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.
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SIST-TS CEN ISO/TS 23406:2021
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.
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SIST-TS CEN ISO/TS 23406:2021
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,
— participation in mandatory trainings,
— satisfactory supervision of the Auditor,

— absence of significant or recurrent complaint related to his auditing activities.

At any time, the CB shall:
— in case of no auditing activity during more than one year,

— after a non-satisfactory supervision and/or examination of an audit report (internal to the

Certification Body or by accreditation body),
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SIST-TS CEN ISO/TS 23406:2021
ISO/TS 23406:2020(E)
— following a client’s significant complaint concerning the auditing activity,
— on request of the Auditor’s management,

consider taking appropriate action, such as: training, withdrawing or suspending auditor qualification.

The CB shall identify the appropriate criteria and relevant process in their management system.

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 follows:

The certification body's certification function shall have at least one person(s) 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 advisors
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 individual external auditors and external technical advisors.

7.5 Outsourcing

The requirements of ISO/IEC 17021-1:2015, 7.5 are complemented by the following requirement:

The Certification shall maintain the responsibility for all functions in Table A.1 and shall not transfer

the responsibility to any other organization.

This doesn’t preclude the Certification Body’s use of organization or individuals which operate

according to the Certification Body’s own procedures and under its control.
8 Information requirements
8.1 Public information
The requirements of ISO/IEC 17021-1:2015, 8.1, apply.
8.2 Certification documents
The requirements of ISO/IEC 17021-1:2015, 8.2, apply.
8.3 Reference to certification and marks
The requirements of ISO/IEC 17021-1:2015, 8.3, apply.
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SIST-TS CEN ISO/TS 23406:2021
ISO/TS 23406:2020(E)
8.4 Confidentiality
The requirements of ISO/IEC 17021-1:2015, 8.4, apply.
8.5 Information exchange between a certification body and its client

The requirements of ISO/IEC 17021-1:2015, 8.5, apply and are complemented as follows:

The certification body shall consider provisions (e.g. authorized auditor, security clearance) for access

to specific sensitive information or material as relevant to the certification scope.

9 Process requirements
9.1 Pre-certification activities
9.1.1 Application
The requirements of ISO/IEC 17021-1:2015, 9.1.1 apply.
9.1.2 Application review
The requirements of ISO/IEC 17021-1:2015, 9.1.2 apply.
9.1.3 Audit programme
The requirements of ISO/IEC 17021-1:2015, 9.1.3 apply.
9.1.4 Determining audit time

The requirements of ISO/IEC 17021-1:2015, 9.1.4, apply, and 9.1.4.2 is complemented as follows:

This table is intended to be used when the entire organization is undergoing an ISO 19443 audit, without

being already ISO 9001 certified. The minimum duration for initial, surveillance, and recertification

audits are shown in Table 1. In this configuration, no reductions are allowed but increases to the minimum

required audit duration are expected for areas with identified risk, complexity or increased scope.

If the activities to be certified according to ISO 19443 are only part of a broader organization, the

Certification Body has to consider the number of employees involved in the nuclear specific activities

and to increase the time specified by Table 1 to take into account the Quality Management System

support functions.

If the Certification Body is already performing the ISO 9001 certification of the organization, the

Certification Body has to apply without reduction the “recertification” duration given in Table 1 in

order to transition to ISO 19443 certification.

The above applies in the event of audit being performed as combined or integrated audits with other

Management System(s).
Table 1 — Minimum audit duration requirements (audit days)
ISO 19443
Number
ISO 19443
of Employees
w/o Design and development (§8.3)
Annual Annual
Initial Recertification Initial Recertification
Surveillance Surveillance
1-5 2,0 1,0 2,0 2,0 1,0 1,5

NOTE These requirements are consistent with IAF MD 5. Where there is a conflict between this standard and IAF MD 5

(i.e., this standard does not allow reductions to the audit duration), this standard shall take precedence.

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SIST-TS CEN ISO/TS 23406:2021
ISO/TS 23406:2020(E)
Table 1 (continued)
ISO 19443
Number
ISO 19443
of Employees
w/o Design and development (§8.3)
Annual Annual
Initial Recertification Initial Recertification
Surveillance Surveillance
6-10 2,5 1,0 2,0 2,5 1,0 1,5
11-15 3,0 1,5 2,5 2,5 1,0 2,0
16-25 3,5 1,5 3,0 3,0 1,5 2,5
26-45 5,0 2,0 4,0 4,5 2,0 3,5
46-65 6,0 2,5 4,5 5,0 2,0 4,0
66-85 7,0 3,0 5,5 6,0 2,5 4,5
86-100 8,0 3,0 6,0 7,0 3,0 5,0
101-125 8,5 3,5 6,5 7,5 3,0 5,5
126-175 9,5 4,0 7,0 8,0 3,5 6,0
176-275 10,5 4,0 8,0 9,0 3,5 6,5
276-425 12,0 5,0 9,0 10,0 4,5 7,5
426-625 13,0 5,5 9,5 11,0 4,5 8,0
626-875 14,0 5,5 10,5 12,0 5,0 8,5
876-1 000 15,0 6,0 11,0 12,5 5,0 9,0
1 001-1 175 16,0 6,5 12,0 13,5 5,5 10,0
1 176-1 550 17,0 7,0 12,5 14,5 6,0 11,0
1 551-2 025 18,0 7,0 13,5 15,0 6,0 11,5
2 026-2 675 19,0 7,5 14,0 16,0 6,5 12,0
2 676-3 450 20,0 8,0 14,5 17,0 7,0 12,5
3 451-4 350 21,0 8,0 15,5 17,5 7,0 13,0
4 351-5 450 22,0 8,5 16,0 18,5 7,5 13,5
5 451-6 800 23,0 9,0 16,5 19,0 7,5 14,0
6 801-8 500 24,0 9,0 17,5 20,0 8,0 14
...

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