1、ANSUISO/ASQ Q9000-2-1997 Quality management and quality assurance standards-Part 2: Guidelines for implementing ANSI/ISO/ASQC Q9001, ANSI/ISO/ASQC Q9002 and ANSI/ISO/ASQC Q9003 Approved as an American National Standard by: American Society for Quality ANSI/ISO/ASQ (29000-2-1997 AMERICAN NATIONAL STA
2、NDARD Quality Management and quality assurance standards Part 2: Guidelines for implementing ANSI/ISO/ASQC Q9001, ANSI/ISO/ASQC Q9002 and ANSl/lSO/ASQC Q9003 Approved as an American National Standard by: American Society for Quality An American National Standard Approved on February 20, 1998 America
3、n National Standards: An American National Standard implies a consensus of those substantially concerned with its scope and provisions. 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 d
4、oes 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 lat
5、est 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 Caution Notice: This American National Standard may be revised or withdrawn at any time.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. Purchas
6、ers of American National Standards may receive current information on all standards by calling or writing the American National Standards Institute. I O 1997 by IS0 Copyright Protection Notice for the ANSI/ISO/ASQ Q9000-2- 1997 Standard. This standard is subject to copyright claims of ISO, ANSI and
7、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 Q9000-2-1997 standard should be submitted to ASQ. Note: As used in the document, the term
8、 “International Standard” refers to the American National Standard adoption of this and other International Standards. ASQ Mission: To facilitate continuous improvement and increase customer satisfac- tion by identifying, communicating, and promoting the use of quality principles, concepts, and tech
9、nologies; and thereby be recognized throughout the world as the leading authority on, and champion for, quality. 10987654321 Printed in the United States of America Printed on acid-free paper Published by: American Society for Quality Quality Press 611 East Wisconsin Avenue Milwaukee, Wisconsin 5320
10、1-3005 Web site hnp:/www.asq.org 800-248-1 946 http:/standardsgroup.asq.org ANSI/ISO/ASQ Q9000-2- 1997 Contents Page 1 Scope . 1 2 Normative references 1 3 Definitions . 1 4 Quality system requirements 4.1 Management responsibility . 4.2 Qualitysystem 4.3 Contract review . 4.4 Designcontrol 4.5 Docu
11、ment and data control . 4.6 Purchasing . 4.7 Control of customer-supplied product . 4.8 Product identification and traceability . 4.9 Process control 4.10 Inspection and testing . 4.11 Control of inspection, measuring and test equipment 4.12 Inspection and test status 4.13 Control of nonconforming p
12、roduct . 4.14 Corrective and preventive action . 4.15 Handling, storage, packaging, preservation and delivery 4.16 Control of quality records 4.17 Internal quality audits . 4.18 Training . 4.19 Servicing 4.20 Statistical techniques . 2 2 3 4 5 7 8 9 10 10 11 12 12 13 13 14 1.5 16 16 17 17 Annex A Bi
13、bliography 19 . 111 Foreword (This Foreword is not a part of American National Standard ANSI/ISO/ASQ 49000-2, Quality management and quality assurance standards-Part 2: Guidelines for implementing ANSI/ISO/ASQC 4900 1, ANSI/ISO/ASQC 49002, ANSI/ISO/ASQC 49003). IS0 (the International Organization fo
14、r Standardization) is a worldwide federation of national standards bodies (IS0 member bodies). The work of preparing International Standards is normally carried out through IS0 techni- cal committees. Each member body interested in a subject for which a technical committee has been established has t
15、he right to be represented on that committee. International organizations, governmental and non-governmen- tal, in liaison with ISO, also take part in the work. IS0 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft
16、 International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75% of the member bodies casting a vote. International Standard IS0 9000-2 was prepared by Technical Committee ISO/TC 17
17、6, Quality managemenf und quality assurance, Subcommittee SC 2, Quality systems. This second edition cancels and replaces the first edition (IS0 9000-2: 1993), which has been technically revised. IS0 9000 consists of the following parts, under the general title Quality managernent and quality assura
18、nce stan- dards. - Part 1: Guidelinesfin- selection and use - Part 2: Generic guidelines for the application of IS0 9001, IS0 9002 and IS0 9003 - Part 3: Guidelines for the application of IS0 9001 to the development, supply and maitztenance of software - Part 4: Guide to dependability management Ann
19、ex A of this part of IS0 9000 is for information only. Comments concerning this standard will be welcome and considered in future standards development and revision. They should be sent to the Standards Administrator, American Society for Quality, 61 1 East Wisconsin Avenue, Milwaukee, W1 53202. V I
20、ntroduction This part of ANSI/ISO/ASQC 49000 gives guidance for the application of ANSI/ISO/ASQC 49001, ANSI/ISO/ASQC 49002 and ANSI/ISO/ASQC 49003. To facilitate cross-reference to those standards, this part of the ANSI/ISO/ASQC 49000 has the same clause structure as the ANSI/ISO/ASQC Q9001, ANSI/I
21、SO/ASQC Q9002 and ANSI/ISO/ASQC Q9003. In general, the number and scope of the quality system elements and procedures required for quality assurance are created in ANSI/ISO/ASQC Q9001 and least in ANSI/ISO/ASQC Q9003. For all clauses, the guidelines of this part of the ANSI/ISO/ASQC 49000 should be
22、applied in a manner consistent with the scope and requirements of the corresponding clause, if present, in the standard involved (i.e. ANSI/ISO/ASQC 49001, ANSI/ISO/ASQC 49002 and ANSI/ISO/ASQC Q9003). Reference should be made to subclause 8.3 of ANSI/ISO/ASQC 49000-1- 1994 for guidance on the appro
23、priate extent and degree of demonstration. ANSI/ISO/ASQC Q9000-1 gives an overview of the series of American National Standards, and explains the use of the entire series. ANSI/ISO/ASQC 49004-1 gives guidance for designing and installing a quality management system. This part of ANSI/ISO/ASQC Q9000
24、does not duplicate the guidance to users that is given in other ANSI/ISO/ASQC standards such as ANSI/ISO/ASQC Q9000- 1, ANSI/ISO/ASQC 49000-3, ANSI/ISO/ASQC 49004-1 and ANSI/ISO/ASQC 49004-2. vii ANSI/ISO/ASQ 49000-2- 1997 QUALITY MANAGEMENT AND QUALITY ASSURANCE APPLICATION OF ANSVISO/ASQC Q9001, A
25、NSI/ISO/ASQC Q9002 AND ANSI/ISO/ASQC Q9003 STANDARDS-PART 2: GENERIC GUIDELINES FOR THE 1 SCOPE This part of ANSI/ISO/ASQC 49000 gives guidance on the application of the 1994 versions of ANSI/ISO/ ASQC Q9001, ANSI/ISO/ASQC 49002 and ANSI/ ISO/ASQC 49003. It does not add to, or otherwise change, the
26、require- ments of ANSI/ISO/ASQC 4900 1, ANSI/ISO/ASQC Q9002 or ANSI/ISO/ASQC 49003. In case of conflict- ing interpretations of ANSI/ISO/ASQC 49001, ANSYISO/ASQC 49002 or ANSVISO/ASQC 49003 on the one hand, and ANSI/ISO/ASQC 49000-2 on the other, the interpretation of the text in ANSI/ISO/ASQC 4900
27、1, ANSI/ISO/ASQC Q9002 or ANSI/ISO/ASQC 49003 takes precedence. The use of “should in this part of the ANSI/ISO/ASQC Q9OOO does not weaken the require- ments expressed as “shall” in ANSI/ISO/ASQC Q9001, ANSVISO/ASQC 49002 or ANSI/ISO/ASQC Q9003. This part of ANSI/ISO/ASQC Q9000 gives guidance for th
28、e following users: a) suppliers involved in applications of ANSI/ISO/ ASQC Q9001, ANSI/ISO/ASQC 49002 or ANSI/ ISO/ASQC Q9003; b) customers and third parties. 2 NORMATIVE REFERENCES The following standards contain provisions which, through reference in this text, constitute provisions of this part o
29、f ANSI/ISO/ASQC 49000. At the time of publication, the editions indicated were valid. All stan- dards are subject to revisions, and parties to agree- ments based on this part of ANSI/ISO/ASQC Q9000 are encouraged to investigate the possibility of apply- ing the most recent editions of the standards
30、indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. ANSI/ISO/ASQC A8402- 1994, Quality management and quality assurance - Vocabulary ANSI/ISO/ASQC Q9001- 1994, Quality systems - Model .for quality assurance in design, development, production, instal
31、lation and servicing. ANSI/ISO/ASQC Q9002- 1994, Quality systems - Model for quality assurance in production, installa- tion and servicing. ANSI/ISO/ASQC Q9003- 1994, Quality systems - Model for quality assurance injnal inspection and test. 3 DEFINITIONS For the purposes of this part of ANSI/ISO/ASQ
32、C Q9000 the definitions given in ANSI/ISO/ASQC A8402 and the following apply. 3.1 contract: Agreed requirements between a supplier and customer transmitted by any means. IS0 90011 3.2 product: Result of activities or processes. NOTE 1 A product may include service, hardware, processed materials, sof
33、tware or a combination thereof. NOTE 2 A product can be tangible (e.g. assemblies or processed materials) or intangible (e.g. knowledge or concepts), or a combination thereof. NOTE 3 For the purposes of this American National Standard, the term product applies to the intended product offering only a
34、nd not to unintended by-prod- ucts affecting the environment. This differs from the definition given in ANSI/ISO/ASQC A8402. IS0 90011 3.3 specified requirements 1) Product requirements prescribed by the customer and agreed by the supplier. 2) Requirements prescribed by the supplier that are perceiv
35、ed as satisfying a market need. 3.4 tender: Offer made by a supplier in response to an invitation to satisfy a contract award to provide product. IS0 90011 1 STD*ASQ Q7U08-2-EN6L L997 075750b 0002b77 IT8 ANSI/ISO/ASQ Q9000-2- 1997 4 QUALITY SYSTEM REQUIREMENTS 4.1 Management responsibility 4.1.1 Qua
36、lity policy The suppliers management with executive responsibil- ity (see 4.1.2.1) is required to develop and define its quality policy, quality objectives and commitment in (a) recorded statement(s). This is required to be rele- vant to its organizational goals, and the expectations and needs of it
37、s customers. The statement(s) should be published throughout the organization and be seen to be fully supported by the management. All employees, including newly hired, part-time and temporary employees, should be trained so that they understand the objectives of the organization and the commitment
38、required to achieve these objectives. The policy should be expressed in language that is easy to understand and the objectives should be achievable, planned and periodically reviewed. Management should continuously demonstrate visible commitment to the quality policy by activities which may include,
39、 but not be limited to, the following: “ensuring that the organizations personnel under- stand and implement the quality policy; -ensuring that the organizations personnel have quality objectives consistent with the organizations overall objectives; -initiating, managing and following up on the impl
40、e- mentation of the quality policy, including implementa- tion and maintenance of the quality system; -not accepting deviations from the quality policy in any part or aspect of the organization; -providing adequate resources and training to support quality system development and implementation. (See
41、 4.1.2.2.) 4.1.2 Organization 4.1.2.1 Responsibility and authority Management with executive responsibility is that per- son or group of persons within an organization with the necessary level of authority for making policy and setting objectives, planning their implementation, reviewing achievement
42、 and taking corrective action. The supplier should clearly identify those persons hav- ing such executive responsibility. 2 In particular the personnel having the responsibility and authority to make decisions that control all the elements of the quality system and processes should be identified and
43、 the job requirements defined and docu- mented (see 4.18). 4.1.2.2 Resources Consideration needs to be given by the suppliers man- agement to the identification and provision of adequate resources needed to implement its quality policy and achieve its objectives as well as to satisfy customer needs
44、and expectations. The following should be con- sidered: -personnel to plan, manage, perform work, control and carry out verification activities; -awareness of standards, procedures and other docu- mented practices that are needed; -training and qualifications (see 4.18); -planning design, developmen
45、t and production activities to allow sufficient time to perform the work; -equipment and processes, including acquisition of new equipment or technology; -means to access quality records. 4.1.2.3 Management representative Within the suppliers organization, a management rep- resentative with delegate
46、d authority is required to be appointed for arranging and overseeing the working of the quality system. This management representative is required to be appointed by management with execu- tive responsibility. The functions of the management representative may be totally related to quality system ac
47、tivities or be in conjunction with other functions and responsibilities within the organization. If the management representa- tive has other functions to perform, there should be no conflict of interest between the responsibilities for the other functions and those for the quality system. The manag
48、ement representative should have the authority to ensure that the requirements of ANSI/ISO/ASQC 4900 1, ANSI/ISO/ASQC 49002 or ANSI/ISO/ASQC 49003 are satisfied and that compliance is maintained, together with the responsibility to ensure that they are operated throughout the organization. The defin
49、ed role should include reporting on the suit- ability and effectiveness of the quality system as a STD-ASQ Q7000-2-ENGL 1997 075750b 0002b78 O34 ANSI/ISO/ASQ 49000-2-1997 basis for improvement, management review, and liai- son, as necessary, with customers, subcontractors and any other external parties on quality matters. 4.1.3 Management review The suppliers management with executive responsibil- ity, should review the quality system. This may include, but not be limited to, the following: -the adequacy of the organizational structure, includ- ing its staffing and other res
