ISO INTERNATIONAL STANDARD 9000 Fourth edition 2015-09-15 Quality management systems Fundamentals and vocabulary Systemes de management de la qualité - Principes essentiels et vocabulaire Reference number IS0 9000:2015(E) ISO IS02015 IHS under itted without license from IHS IS0 9000:2015(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 @ IS0 2015 - All rights reserved No reproductic IS0 9000:2015(E) Contents Page Foreword ..iv Introduction. ..V 1 Scope. 2 Fundamental concepts and quality management principles 2.1 General .1 2.2 Fundamental concepts. .2 2.2.1 Quality 2 2.2.2 Quality management system .2 2.2.3 Context of an organization 2 2.2.4 Interested parties. 2 2.2.5 Support. 2 2.3 Quality management principles 3 2.3.1 Customer focus. .3 2.3.2 Leadership. 4 2.3.3 Engagement of people .5 2.3.4 Process approach 6 2.3.5 Improvement .6 2.3.6 Evidence-based decision making .7 2.3.7 Relationship management .8 2.4 Developing the QMS using fundamental concepts and principles .9 2.4.1 QMS model .9 2.4.2 Development of a QMS .9 2.4.3 QMS standards, other management systems and excellence models ..10 3 Terms and definitions .10 3.1 Terms related to person or people .10 3.2 Terms related to organization. .11 3.3 Terms related to activity .13 3.4 Terms related to process .15 3.5 Terms related to system. 16 3.6 Terms related to requirement. .18 3.7 Terms related to result 20 3.8 Terms related to data, information and document. 23 3.9 Terms related to customer 25 3.10 Terms relatedto characteristic 26 3.11 Terms related to determination 27 3.12 Terms related to action. 29 3.13 Terms related to audit 30 Annex A (informative) Concept relationships and their graphical representation ..33 Bibliography .47 Alphabetical index of terms .49 iii vided by IHS under I ense with ISt withoutlicense from IHS