ISO INTERNATIONAL STANDARD 9001 Fifth edition 2015-09-15 Quality management systems Requirements Systemes de management de la qualité - Exigences Reference number IS0 9001:2015(E) ISO @ISO2015 IS0 9001:2015(E) COPYRIGHTPROTECTEDDOCUMENT IS0 2015, Published in Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form written permission. Permission can be requested from either ISO at the address below or ISO's member body in the country of the requester. IsOcopyrightoffice Ch. de Blandonnet 8 . CP 401 CH-1214 Vernier, Geneva, Switzerland Tel. +41 22 749 01 11 Fax +41 22 749 09 47 [email protected] www.iso.org ii @ IS0 2015 - All rights reserved IS0 9001:2015(E) Contents Page Foreword ..V Introduction. ..vi 1 Scope. 2 Normative references 3 Terms and definitions ..1 4 Context of the organization 4.1 Understanding the organization and its context .1 4.2 Understanding the needs and expectations of interested parties ..2 4.3 Determining the scope of the quality management system. .2 4.4 Quality management system and its processes.. 5 Leadership ..3 5.1 Leadership and commitment. .3 5.1.1 General ..3 5.1.2 Customer focus. .3 5.2 Policy ..4 5.2.1 Establishing the quality policy. ..4 5.2.2 Communicating the quality policy . 4 5.3 Organizational roles, responsibilities and authorities. .4 6 Planning. ..4 6.1 Actions to address risks and opportunities 6.2 Quality objectives and planning to achieve them ..5 6.3 Planning of changes. ..5 7 Support. .6 7.1 Resources.. .6 7.1.1 General ..6 7.1.2 People. 7.1.3 Infrastructure .6 7.1.4 Environment for the operation of processes ..6 7.1.5 Monitoring and measuring resources 7 7.1.6 Organizational knowledge. ..7 7.2 Competence ..8 7.3 Awareness. 7.4 Communication .8 7.5 Documented information .8 7.5.1 General. 7.5.2 Creating and updating .9 7.5.3 Control of documented information ..9 8 Operation 8.1 Operational planning and control .9 8.2 Requirements for products and services 10 8.2.1 Customercommunication ..10 8.2.2 Determining the requirements for products and services ..10 8.2.3 Review of the requirements for products and services ..10 8.2.4 Changes to requirements for products and services. ..11 8.3 Design and development of products and services ..11 8.3.1 General. .11 8.3.2 Design and development planning. ..1 8.3.3 Design and development inputs. .11 8.3.4 Design and development controls ..12 8.3.5 Design and development outputs .12 8.3.6 Design and development changes. .12 @ IS0 2015 - All rights reserved ii