|
SLOVENSKI STANDARD
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword . 3
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.
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
ISO/TR 4450:2020(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
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.
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Email: [email protected]
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Published in Switzerland
ii © ISO 2020 – All rights reserved
ISO/TR 4450:2020(E)
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
ISO/TR 4450:2020(E)
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 .
...