ISO INTERNATIONAL 19443 STANDARD First edition 2018-05 Quality management systems Specific requirements for the application of IS0 9001:2015 by organizations in the supply chain of the nuclear energy sector supplying products and services important to nuclear safety (ITNS) Systemes de management de la qualité - Exigences spécifiques pour I'application de I'lS0 9001:2015 par les organisations de la chaine d'approvisionnement du secteur de I'énergie nucléaire fournissant des produits ou services importants pour la sureté nucléaire (IPNS) Reference number IS0 19443:2018(E) ISO @ IS0 2018 IS0 19443:2018(E) COPYRIGHT PROTECTED DOCUMENT @ IS0 2018 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: +41227490947 Email: [email protected] Website: www.iso.org Published in Switzerland ii @ IS0 2018 - All rights reserved IS0 19443:2018(E) Contents Page Foreword V Introduction vi 1 Scope .1 2 Normative references. .2 3 Terms and definitions .2 4 Context of the organization. 4 4.1 Understanding the organization and its context. 4 4.2 Understanding the needs and expectations of interested parties 4 4.3 Determining the scope of the quality management system. 5 4.4 Quality management system and its processes Leadership 5 6 5.1 Leadership and commitment 6 5.1.1 General. 6 5.1.2 Customer focus 7 5.1.3 Nuclear safety culture 7 5.2 Policy. 8 5.2.1 Establishing the quality policy 8 5.2.2 Communicating the quality policy 8 5.3 Organizational roles, responsibilities and authorities 9 Planning .10 6 6.1 Actions to address risks and opportunities 10 6.2 Quality objectives and planning to achieve them. 11 Planning of changes. 6.3 12 Support .13 7 Resources. 7.1 13 7.1.1 General. 13 People. 7.1.2 13 7.1.3 Infrastructure 13 7.1.4 Environment for the operation of processes 14 7.1.5 Monitoring and measuring resources 14 7.1.6 Organizational knowledge. 15 7.2 Competence 16 7.3 Awareness 17 7.4 Communication.. 17 7.5 Documented information 18 7.5.1 General. 18 7.5.2 Creating and updating 18 7.5.3 Control of documented information 19 8 Operation .20 8.1 Operational planning and control 20 Provisions for counterfeit, fraudulent or suspect (CFS) items 20 8.1.1 8.2 Requirements for products and services. 21 Customer communication. 21 8.2.1 8.2.2 Determination of requirements related for products and services 21 8.2.3 Review of the requirements for products and services 22 .23 8.2.4 Changes to requirements for products and services... 32 8.3 Design and development of products and services. 8.3.1 General.. Design and development planning. 23 8.3.2 .24 8.3.3 Design and development inputs 8.3.4 Design and development controls 24 @ IS0 2018 - All rights reserved iii