CEN ISO/TR 4450:2022

Quality management systems - Guidance for the application of ISO 19443:2018 (ISO/TR 4450:2020)

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.

Qualitätsmanagementsysteme - Leitfaden für die Anwendung von ISO 19443:2018 (ISO/TR 4450:2020)

Dieses Dokument stellt einen Leitfaden für die Umsetzung der Anforderungen von ISO 19443 bereit, mit Beispie¬len für mögliche Schritte, die eine Organisation ergreifen kann, um die Anforderungen zu erfüllen.
Dieses Dokument ergänzt, entfernt oder ändert in irgendeiner Weise diese Anforderungen.
Dieses Dokument schreibt keine verbindlichen Ansätze für die Umsetzung vor bzw. liefert es kein bevorzugtes Verfahren zur Interpretation.

Systèmes de management de la qualité - Lignes directrices pour l'application de l'ISO 19443:2018 (ISO/TR 4450:2020)

Le présent document fournit des recommandations relatives à la mise en œuvre des exigences de l’ISO 19443, accompagnées d’exemples de solutions pouvant être adoptées par un organisme pour répondre aux exigences.
Il ne complète pas, n’ampute pas ou ne modifie pas de quelque manière que ce soit lesdites exigences.
Le présent document ne prescrit pas d’approches obligatoires pour la mise en œuvre, ou ne préconise aucune méthode d’interprétation particulière.

Sistemi vodenja kakovosti - Navodila za uporabo standarda ISO 19443:2018 (ISO/TR 4450:2020)

Ta dokument podaja navodila za izvajanje zahtev standarda ISO 19443, vključno s primeri možnih korakov, s katerimi lahko organizacija izpolni zahteve.
Standard zahtevam nič ne dodaja ali jim odvzema ter jih ne spreminja na noben način.
Ta dokument ne predpisuje zahtevanih pristopov za izvajanje in ne podaja prednostnih načinov interpretacije.

General Information

• Status: Published
• Publication Date: 25-Oct-2022
• ICS: 03.100.70 - Management systems
• ICS: 03.120.10 - Quality management and quality assurance
• ICS: 27.120.01 - Nuclear energy in general
• Technical Committee: CEN/TC 430 - Nuclear energy, nuclear technologies, and radiological protection
• Drafting Committee: CEN/TC 430 - Nuclear energy, nuclear technologies, and radiological protection
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 26-Oct-2022
• Due Date: 11-Dec-2023
• Completion Date: 26-Oct-2022
• Ref Project: SIST-TP CEN ISO/TR 4450:2023 - Quality management systems - Guidance for the application of ISO 19443:2018 (ISO/TR 4450:2020)

Standards Content (Sample)

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.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
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 .
...