SIST-TP CEN ISO/TR 4450:2023

SLOVENSKI STANDARD
SIST-TP CEN ISO/TR 4450:2023
01-januar-2023
Sistemi vodenja kakovosti - Navodila za uporabo standarda ISO 19443:2018
(ISO/TR 4450:2020)
Quality management systems - Guidance for the application of ISO 19443:2018 (ISO/TR
4450:2020)
Systèmes de management de la qualité - Lignes directrices pour l'application de l'ISO
19443:2018 (ISO/TR 4450:2020)
Ta slovenski standard je istoveten z: CEN ISO/TR 4450:2022
ICS:
03.100.70 Sistemi vodenja Management systems
03.120.10 Vodenje in zagotavljanje Quality management and
kakovosti quality assurance
27.120.01 Jedrska energija na splošno Nuclear energy in general
SIST-TP CEN ISO/TR 4450:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST-TP CEN ISO/TR 4450:2023

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SIST-TP CEN ISO/TR 4450:2023


CEN ISO/TR 4450
TECHNICAL REPORT

RAPPORT TECHNIQUE

October 2022
TECHNISCHER REPORT
ICS 03.120.10; 27.120.01; 03.100.70
English Version

Quality management systems - Guidance for the
application of ISO 19443:2018 (ISO/TR 4450:2020)
Systèmes de management de la qualité - Lignes
directrices pour l'application de l'ISO 19443:2018
(ISO/TR 4450:2020)


This Technical Report was approved by CEN on 23 October 2022. It has been drawn up by the Technical Committee CEN/TC 430.

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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. CEN ISO/TR 4450:2022 E
worldwide for CEN national Members.

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Contents Page
European foreword . 3

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European foreword
The text of ISO/TR 4450:2020 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/TR 4450:2022 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.
Endorsement notice
The text of ISO/TR 4450:2020 has been approved by CEN as CEN ISO/TR 4450:2022 without any
modification.

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SIST-TP CEN ISO/TR 4450:2023
TECHNICAL ISO/TR
REPORT 4450
First edition
2020-09
Quality management systems —
Guidance for the application of ISO
19443:2018
Systèmes de management de la qualité — Lignes directrices pour
l'application de l'ISO 19443:2018
Reference number
ISO/TR 4450:2020(E)
©
ISO 2020

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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
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

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Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Context of the organization . 1
4.1 Understanding the organization and its context . 1
4.2 Understanding the needs and expectations of interested parties . 1
4.3 Determining the scope of the quality management system . 1
4.4 Quality management system and its processes . 1
5 Leadership . 2
5.1 Leadership and commitment . 2
5.1.1 General. 2
5.1.2 Customer focus . 2
5.1.3 Nuclear safety culture . 2
5.2 Policy . 3
5.2.1 Establishing the quality policy . 3
5.2.2 Communicating the quality policy . 3
5.3 Organizational roles, responsibilities and authorities. 3
6 Planning . 3
6.1 Actions to address risks and opportunities . 3
6.2 Quality objectives and planning to achieve them . 6
6.3 Planning of changes . 6
7 Support . 6
7.1 Resources . 6
7.1.1 General. 6
7.1.2 People . 7
7.1.3 Infrastructure . 7
7.1.4 Environment for the operation of processes . 7
7.1.5 Monitoring and measuring resources . 7
7.1.6 Organizational knowledge . 8
7.2 Competence . 8
7.3 Awareness . 8
7.4 Communication . 8
7.5 Documented information . 8
7.5.1 General. 9
7.5.2 Creating and updating . 9
7.5.3 Control of documented information . 9
8 Operation .10
8.1 Operational planning and control .10
8.1.1 Provisions for Counterfeit, Fraudulent or Suspect (CFS) items .10
8.2 Requirements for products and services .10
8.2.1 Customer communication .10
8.2.2 Determination of requirements related for products and services .10
8.2.3 Review of requirements related for products and services .10
8.2.4 Changes to requirements for products and services .10
8.3 Design and development of products and services .10
8.4 Control of externally provided processes, products and services .10
8.4.1 General.10
8.4.2 Type and extent of control .11
8.4.3 Information for external providers .12
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8.5 Production and service provision .12
8.5.1 Control of production and service provision .12
8.5.2 Identification and traceability .12
8.5.3 Property belonging to customers or external providers .12
8.5.4 Preservation .12
8.5.5 Post-delivery activities .12
8.5.6 Control of changes .13
8.6 Release of products and services .13
8.7 Control of nonconforming outputs .13
9 Performance evaluation .13
9.1 Monitoring, measurement, analysis and evaluation .13
9.1.1 General.13
9.1.2 Customer satisfaction .13
9.1.3 Analysis and evaluation .13
9.2 Internal audit .13
9.3 Management review .13
9.3.1 General.13
9.3.2 Management review inputs .13
9.3.3 Management review outputs .13
10 Improvement .14
10.1 General .14
10.2 Nonconformity and corrective action .14
10.3 Continual improvement .14
Annex A (informative) Additional requirements of ISO 19443:2018 versus ISO 9001:2015.15
Annex B (informative) How to perform a risk analysis for the project? .18
Annex C (informative) Determination of ITNS items and activities .22
Annex D (informative) Practical example of determination of ITNS items and activities .24
Annex E (informative) Typical (general) example for graded approach .27
Annex F (informative) Practical example of graded approach .29
Annex G (informative) Metrological guidelines .32
Annex H (informative) Competence and qualification .35
Annex I (informative) Awareness training for personnel .38
Annex J (informative) List of ISO 19443 additional requirements related to documented
information .42
Annex K (informative) Good practices for 8.3 .45
Annex L (informative) Demonstration of the evidence of provisions for monitoring activities .50
Annex M (informative) Example of scheme for non-conformance information and request
for approval along supply chain .53
Bibliography .54
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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 relationship of ISO standards to the IAEA safety standards (http:// www -ns .iaea .org/ standards/ )
needs to be understood to avoid confusions.
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/directives).
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/patents).
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 the Technical Committee ISO/TC 85, Nuclear energy, nuclear
technologies, and radiological protection WG 4, Management systems and conformity assessment.
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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Introduction
As general consideration, this guideline document:
— has been developed to assist users to apply the quality management system requirements of
ISO 19443:2018 by organizations in the supply chain of the nuclear energy sector supplying products
[1]
and services important to nuclear safety (ITNS) ,
— does not add to, subtract from, or in any way modify those requirements,
— does not prescribe mandatory approaches to implementation, or provide any preferred method of
[2]
interpretation of ISO 19443:2018 requirements supplementing those of ISO 9001:2015 , but only
provide examples of possible solutions an organization can implement to meet the requirements,
— proposes also good practices for some clauses of ISO 9001 when applied to ISO 19443.
[2]
Where there is no supplementary text to ISO 9001 (refer also to Annex A which gives a global picture
of additional requirements of ISO 19443:2018 versus ISO 9001:2015), the sentence “No ISO 19443
additional requirement to ISO 9001” has been included. In this case, for guidance on the initial text of
ISO 9001, refer to:
[2]
• ISO 9001:2015 , Annex A,
[3]
• ISO/TS 9002 , and
[4]
• ISO/IAF Auditing Practices Group .
Where it is considered that the added text is self-explanatory and thus no guidance has been added, the
sentence “No supplementary guidance provided “ has been included.
This guidance follows the layout of ISO 19443 and thus, users need to clearly understand the vocabulary
of ISO 9000 and ISO 9001, which underlie it, before addressing the added text in ISO 19443.
The delivery of all products or services will involve tiers (See Figure 1) to which the Licensee
requirements will be cascaded through Contractor(s) using technical specifications, procedures,
management system (including Quality Assurance and Quality Control) requirements, and other
contractual documents.
At each level, the external provider (called hereby “contractor”, “supplier” or “sub-supplier”) will be
potentially in position to be “the organization” considered by ISO 19443.
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Figure 1 — Schematic breakdown of tiers.
0.1 General
No ISO 19443 additional requirement to ISO 9001.
0.2 Quality management principles
No supplementary guidance provided.
0/3 Process approach
No ISO 19443 additional requirement to ISO 9001.
0.4 Relationship with other management system standards
No supplementary guidance provided.
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TECHNICAL REPORT ISO/TR 4450:2020(E)
Quality management systems — Guidance for the
application of ISO 19443:2018
1 Scope
This document provides guidance on the implementation of the ISO 19443 requirements, with examples
of possible steps an organization can take to meet the requirements.
It does not add to, subtract from, or in any way modify those requirements.
This document does not prescribe mandatory approaches to implementation, or provide any preferred
method of interpretation.
2 Normative references
There are no normative references in this document.
No ISO 19443 additional requirement to ISO 9001.
3 Terms and definitions
No terms and definitions are listed in this document.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
4 Context of the organization
4.1 Understanding the organization and its context
As part of risk-based thinking of ISO 19443:2018, 0.3.3, the organization should consider any risks and
the nuclear safety implications to its activities.
Refer also to Annex B.
4.2 Understanding the needs and expectations of interested parties
No ISO 19443 additional requirement to ISO 9001.
4.3 Determining the scope of the quality management system
No ISO 19443 additional requirement to ISO 9001.
4.4 Quality management system and its processes
4.4.1 No ISO 19443 additional requirement to ISO 9001.
4.4.2 No ISO 19443 additional requirement to ISO 9001.
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[5]
4.4.3 Refer to ISO 9000:2015 for definition of quality manual or quality plan and to following
standards referenced in ISO 9001:2015, Annex B:
[6]
— ISO 10005, Quality management systems — Guidelines for quality plans . This document provides
guidance on establishing and using quality plans as a means of relating requirements of the process,
product, project or contract, to work methods and practices that support product realization.
Benefits of establishing a quality plan are increased confidence that requirements will be met, that
processes are in control and the motivation that this can give to those involved.
[7]
— ISO 10006, Quality management systems — Guidelines for quality management in projects . This
document is applicable to projects from the small to large, from simple to complex, from an individual
project to being part of a portfolio of projects. ISO 10006 is to be used by personnel managing
projects and who need to ensure that their organization is applying the practices contained in the
ISO quality management
The intent of this subclause is for the organization to demonstrate compliance with ISO 19443
requirements, whatever the form, format or media. Quality manual and/or quality plan are examples
of typical ways to comply with this clause, but any other means (e.g. matrix, correspondence table, etc.)
can be used.
5 Leadership
Material can be found as guidelines for whole chapter 5 in the following documents.
[21]
— IAEA, Safety Series No.75-INSAG-4, 1991 – Safety Culture
[22]
— INPO – “Principles for a Strong Nuclear Safety Culture”
[23]
— WANO – Principles PL | 2013-1 - Traits of a Healthy Nuclear Safety Culture
[24]
— IAEA, No.INSAG-10, 1996 – Defence in Depth in Nuclear Safety
[25]
— AIEA, No.INSAG-13, 1999 – Management of Operational Safety in Nuclear Power Plants
[26]
— IAEA, No.INSAG-15, 2002 – Key Practical Issues in Strengthening Safety Culture
[27]
— IAEA Bulletin 50-1 – September 2008 – The mind-set of nuclear safety
[28]
— IAEA General Safety Requirements - GSR Part 2:2016 - Leadership and Management for Safety
— IA
...