AMERICAN NATIONAL STANDARD - Quality Web Based …

1 AMERICAN NATIONAL STANDARD Quality management systems Requirements AMERICAN SOCIETY FOR Quality BOX 3005 MILWAUKEE, WI 53201-3005 ANSI/ISO/ASQ(E) Q9001- 2008 MULTI-USER LICENSE ONLY, COPYING AND NETWORKING to Quality WBT Center for Russell by ASQ ( ) Order# 1001191018 Downloaded: 11/20/ 2008 (This page intentionally left blank)MULTI-USER LICENSE ONLY, COPYING AND NETWORKING to Quality WBT Center for Russell by ASQ ( ) Order# 1001191018 Downloaded: 11/20/ 2008 AMERICAN NATIONAL STANDARD Quality management systems Requirements Approved as an AMERICAN NATIONAL STANDARD by: AMERICAN Society for Quality November 15, 2008 AMERICAN NATIONAL standards : An AMERICAN NATIONAL STANDARD implies a consensus of those substantially concerned with is scope and provisions.

2 An AMERICAN NATIONAL STANDARD is intended as a guide to aid the manufacturer, the consumer, and the general public. The existence of an AMERICAN NATIONAL STANDARD does not in any respect preclude anyone, whether he or she has approved the STANDARD or not, from manufacturing, purchasing, or using products, processes, or procedures not conforming to the STANDARD . AMERICAN NATIONAL standards are subject to periodic review and users are cautioned to obtain the latest edition. Caution Notice: This AMERICAN NATIONAL STANDARD may be revised or withdrawn at any time. The procedures of the AMERICAN NATIONAL standards Institute require that action be taken to reaffirm, revise, or withdraw this STANDARD no later than five years from the date of publication.

3 Purchasers of AMERICAN NATIONAL standards may receive current information on all standards by calling of writing the AMERICAN NATIONAL standards Institute. ANSI/ISO/ASQ(E) Q9001-2008iiiMULTI-USER LICENSE ONLY, COPYING AND NETWORKING to Quality WBT Center for Russell by ASQ ( ) Order# 1001191018 Downloaded: 11/20/ 2008 2008 by ASQC opyright Protection Notice for the ANSI/ISO/ASQ Q9001- 2008 STANDARD . This STANDARD is subject to copyright claims of ISO, ANSI, and ASQ. Not for resale. No part of this publication may be reproduced in any form, including an electronic retrieval system, without the prior written permission of ASQ. All requests pertaining to the ANSI/ISO/ASQ Q9001- 2008 STANDARD should be submitted to : As used in this document, the term International STANDARD refers to the AMERICAN NATIONAL STANDARD adoption of this and other International will consider requests for change and information on the submittal of such requests regarding this STANDARD .

4 All requests should be in writing to the attention of the standards administrator at the address Mission: The AMERICAN Society for Quality advances individual and organizational performance excellence worldwide by providing opportunities for learning, Quality improvement, and knowledge by:COPYRIGHT PROTECTED DOCUMENTPDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobe s licensing policy, this file may be viewed but shall not be edited or printed. In downloading this file, parties therein accept the responsibility of not infringing on Adobe s licensing policy. ASQ accepts no liability in this is a trademark of Adobe Systems of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creating parameters were optimized for printing.

5 Every care has been taken to ensure that the file is suitable for use by our customers. In the unlikely event that a problem relating to it is found, please inform ASQ at the address (E) Q9001-2008ivMULTI-USER LICENSE ONLY, COPYING AND NETWORKING to Quality WBT Center for Russell by ASQ ( ) Order# 1001191018 Downloaded: 11/20/ 2008 Also available from ASQ Quality Press: iso 9001 : 2008 explained , Third Edition Charles A. Cianfrani, John E. (Jack) West, and Joseph J. Tsiakals ISO Lesson Guide 2008 : Pocket Guide to iso 9001 - 2008 , Third Edition Russell and Dennis R. Arter iso 9001 : 2008 Internal Audits Made Easy: Tools, Techniques and Step-by-Step Guidelines for Successful Internal Audits, Second Edition Ann W.

6 Phillips How to Audit the Process- Based QMS Dennis R. Arter, John E. (Jack) West, and Charles A. Cianfrani The ASQ Auditing Handbook, Third Edition Russell, editing director Quality Audits for Improved Performance, Third Edition Dennis R. Arter Unlocking the Power of Your QMS: Keys to Business Performance Improvement John E. (Jack) West and Charles A. Cianfrani The Quality Toolbox, Second Edition Nancy R. Tague Mapping Work Processes, Second Edition Bj rn Andersen, Tom Fagerhaug, Bj rnar Henriksen, and Lars E. Ons yen Lean Kaizen: A Simplified Approach to Process Improvements George Alukal and Anthony Manos Root Cause Analysis: Simplified Tools and Techniques, Second Edition Bj rn Andersen and Tom Fagerhaug The Certified Manager of Quality /Organizational Excellence Handbook, Third Edition Russell T.

7 Westcott, editor Enabling Excellence: The Seven Elements Essential to Achieving Competitive Advantage Timothy A. Pine To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our Web site at ANSI/ISO/ASQ(E) Q9001-2008vMULTI-USER LICENSE ONLY, COPYING AND NETWORKING to Quality WBT Center for Russell by ASQ ( ) Order# 1001191018 Downloaded: 11/20/ 2008 (This page intentionally left blank)MULTI-USER LICENSE ONLY, COPYING AND NETWORKING to Quality WBT Center for Russell by ASQ ( ) Order# 1001191018 Downloaded: 11/20/ 2008 Contents Page1 Scope .. General .. Application .. 12 Normative references .. 13 Terms and definitions .. 14 Quality management system.

8 General requirements .. Documentation requirements .. 25 Management responsibility .. Management commitment .. Customer focus .. Quality policy .. Planning .. Responsibility, authority and communication .. Management review .. 56 Resource management .. Provision of resources .. Human resources .. Infrastructure .. Work environment .. 67 Product realization .. Planning of product realization .. Customer-related processes .. Design and development .. Purchasing .. Production and service provision .. Control of monitoring and measuring equipment.

9 118 Measurement, analysis and improvement .. General .. Monitoring and measurement .. Control of nonconforming product .. Analysis of data .. Improvement .. 14 Annex A(informative)Correspondence between iso 9001 : 2008 and ISO 14001:2004 .. 15 Annex B(informative)Changes between iso 9001 :2000 and iso 9001 : 2008 .. 20 Bibliography .. 26 ANSI/ISO/ASQ(E) Q9001-2008viiMULTI-USER LICENSE ONLY, COPYING AND NETWORKING to Quality WBT Center for Russell by ASQ ( ) Order# 1001191018 Downloaded: 11/20/ 2008 ForewordISO (the International Organization for Standardization) is a worldwide federation of NATIONAL standards bodies(ISO member bodies). The work of preparing International standards is normally carried out through ISOtechnical committees.

10 Each member body interested in a subject for which a technical committee has beenestablished has the right to be represented on that committee. International organizations, governmental andnon-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the InternationalElectrotechnical Commission (IEC) on all matters of electrotechnical standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part main task of technical committees is to prepare International standards . Draft International Standardsadopted by the technical committees are circulated to the member bodies for voting. Publication as anInternational STANDARD requires approval by at least 75 % of the member bodies casting a is drawn to the possibility that some of the elements of this document may be the subject of patentrights.