Mtbf

INTERNATIONAL STANDARD

ISO 9000
Third edition 2005-09-15

Quality management systems — Fundamentals and vocabulary
Systèmes de management de la qualité — Principes essentiels et vocabulaire

Reference number ISO 9000:2005(E)

© ISO 2005

ISO 9000:2005(E)

PDF disclaimer This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may beprinted or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this area. Adobe is a trademark of Adobe Systems Incorporated. Details of the softwareproducts used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

© ISO 2005 All rightsreserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or ISO's member body in the country of the requester. ISO copyright office Case postale 56 • CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 74909 47 E-mail copyright@iso.org Web www.iso.org Published in Switzerland

ii

© ISO 2005 – All rights reserved

ISO 9000:2005(E)

Contents
1 2

Page

Scope .................................................................................................................................................... Fundamentals of quality management systems...............................................................................

1 1 1 1 2 2 2 3 4 4 5 6 6 6 6 7 8 9 11 12 13 14 15 16 18 20 29 30

2.1 Rationale for quality management systems ..................................................................................... 2.2 Requirements for quality management systems and requirements for products ........................ 2.3 Quality management systems approach........................................................................................... 2.4 The process approach ........................................................................................................................ 2.5 Quality policy and quality objectives ................................................................................................ 2.6 Role of top management withinthe quality management system ................................................. 2.7 Documentation .................................................................................................................................... 2.8 Evaluating quality management systems ......................................................................................... 2.9 Continual improvement...................................................................................................................... 2.10 2.11 2.12 3 Role of statistical techniques ........................................................................................................... Quality management systems and other management system focuses ..................................... Relationship between qualitymanagement systems and excellence models ............................ Terms and definitions ..........................................................................................................................

3.1 Terms relating to quality ..................................................................................................................... 3.2 Terms relating to management...