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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 2024
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ii
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
Annex C (normative) Eligibility criteria for multi-site sampling .16
Bibliography . 17
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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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).
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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)
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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.
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