ASQ-ASQ-9001-EXCERPTED-2000.pdf
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1、Excerpted Version: Quality management systems Requirements (An abridged document for auditors) AMERICAN SOCIETY FOR QUALITY P.O. BOX 3005 MILWAUKEE,WISCONSIN 53201-3005 Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie
2、Not for Resale, 04/18/2007 11:00:24 MDTNo reproduction or networking permitted without license from IHS -,-,- Excerpted Version: Quality management systems Requirements (An abridged document for auditors) Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Empl
3、oyees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 11:00:24 MDTNo reproduction or networking permitted without license from IHS -,-,- 2001 by ASQ Copyright Protection Notice for the ANSI/ISO/ASQ Q9000-2000 Standard. This standard is subject to copyright claims of ISO, ANSI, and ASQ. Not
4、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 Q9000-2000 Standard should be submitted to ASQ. Note: As used in this document, the term “Internat
5、ional Standard“ refers to the American National Standard adoption of this and other International Standards. ASQ will consider requests for change and information on the submittal of such requests regarding this Standard. All requests should be in writing to the attention of the Standards administra
6、tor at the address below. ASQ Mission: The American Society for Quality advances individual and organizational performance excellence worldwide by providing opportunities for learning, quality improvement, and knowledge exchange. Quality Press P.O. Box 3005 Milwaukee, Wisconsin 53201-3005 800-248-19
7、46 Fax: 414-272-1734 www.asq.org http:/qualitypress.asq.org http:/standardsgroup.asq.org Published by: Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 11:00:24 MDTNo reproduction or networki
8、ng permitted without license from IHS -,-,- Additional resources on the ANSI/ISO/ASQ Q9000-2000 Standards available from ASQ Quality Press: ISO 9001:2000 Explained, Second Edition Charles A. Cianfrani, Joseph J.Tsiakals, and John E. (Jack) West The ISO Lesson Guide 2000: Pocket Guide to Q9001:2000,
9、Second Edition Dennis Arter and J. P. Russell ISO 9001:2000 An Audio Workshop and Master Slide Presentation John E. (Jack) West and Charles A. Cianfrani ISO 9001:2000 Quick Reference Jeanne Ketola and Kathy Roberts ISO 9000 at the Front Line William A. Levinson After the Quality Audit: Closing the L
10、oop on the Audit Process, Second Edition J. P. Russell and Terry Regel Internal Quality Auditing Denis Pronovost Quality Press has created an ISO 9000:2000 Resource Materials Web page.This convenient online resource contains links to all the books, journals, standards, and courses that are available
11、 through ASQ (as well as general information and FAQs) on this important revision to the standards. You can visit this page from our Online Bookstore at http:/qualitypress.asq.org . To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our Online Bookstore
12、 at http:/qualitypress.asq.org . Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 04/18/2007 11:00:24 MDTNo reproduction or networking permitted without license from IHS -,-,- Foreword This document was
13、 designed form customer feedback which indicated a desire by some in the auditing commu- nity to have a compact version of just the quality man- agement system requirements contained in the ANSI/ISO/ASQ Q9001-2000. It is not intended to be used as a standard.Those wish- ing the full content of the s
14、tandard should use the unabridged ANSI/ISO/ASQ Q9001-2000.Those needing clarification of the concepts and terminology contained in this or the full standard should use the ANSI/ISO/ASQ Q9000-2000. Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/11
15、11111001, User=Wing, Bernie Not for Resale, 04/18/2007 11:00:24 MDTNo reproduction or networking permitted without license from IHS -,-,- 4 Quality management system 4.1 General requirements The organization shall establish, document, implement and maintain a quality management system and continuall
16、y improve its effectiveness in accordance with the requirements of this International Standard. The organization shall a)identify the processes needed for the quality management system and their application throughout the organization (see 1.2), b)determine the sequence and interaction of these proc
17、esses, c)determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d)ensure the availability of resources and informa- tion necessary to support the operation and monitoring of these processes, e)monitor, measure and analyse these processes
18、, and f)implement actions necessary to achieve planned results and continual improvement of these processes. These processes shall be managed by the organiza- tion in accordance with the requirements of this International Standard. Where an organization chooses to outsource any process that affects
19、product conformity with require- ments, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system. NOTE Processes needed for the quality management system referred to above should include processes for man
20、agement activities, provision of resources, product realization and measurement. 4.2 Documentation requirements 4.2.1 General The quality management system documentation shall include a)documented statements of a quality policy and quality objectives, b)a quality manual, c)documented procedures requ
21、ired by this International Standard, d)documents needed by the organization to ensure the effective planning, operation and control of its processes, and 1 Copyright American Society for Quality Provided by IHS under license with ASQ Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resal
22、e, 04/18/2007 11:00:24 MDTNo reproduction or networking permitted without license from IHS -,-,- e)records required by this International Standard (see 4.2.4). NOTE 1 Where the term “documented procedure“ appears within this International Standard, this means that the procedure is established, docum
23、ented, imple- mented and maintained. NOTE 2 The extent of the quality management system documentation can differ from one organization to another due to a)the size of organization and type of activities, b)the complexity of processes and their interac- tions, and c)the competence of personnel. NOTE
24、3 The documentation can be in any form or type of medium. 4.2.2 Quality manual The organization shall establish and maintain a quality manual that includes a)the scope of the quality management system, including details of and justification for any exclusions (see 1.2), b)the documented procedures e
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