ANSI ASQ Q9000-3-1997 Quality Management and Quality Assurance Standards - Part 3 Guidelines for the Application of ANSI ISO ASQC Q9001-1994 to the Development Supply Installation .pdf

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1、ANSI/ISO/ASQ 49000-3-1997 Quality management and quality assurance standards- Part 3: Guidelines for the application of ANSI/ISO/ASQC maintenance of computer software J Q9001-1994 to the development, supply, installation and Approved as an American National Standard by: American Society for Quality

2、ANSI/ISO/ASQ (29000-3-1 997 AMERICAN NATIONAL STANDARD Quality management and quality assurance- Part 3: Guidelines for the application of ANSI/ISO/ASQC Q9001-1994 to the development, supply, installation and maintenance of computer software Approved as an American National Standard by: American Soc

3、iety for Quality An American National Standard Approved on August 18, 1998 American 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

4、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

5、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 Caution Notice: This American National Standard may be revised or withdrawn at any time.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 wit

6、hdraw this standard no later than five years from the date of publication. Purchasers 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

7、Q9000-3- 1997 Standard. This standard is subject to copyright claims of EO, 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 Q900

8、0-3-1997 standard should be submitted to ASQ. Note: As used in the document, the term “International Standard” refers to the American National Standard adoption of this and other International Standards. ASQ Mission: The American Society for Quality advances individual and organiza- tional performan

9、ce excellence worldwide by providing opportunities for learning, quality improvement, and knowledge exchange. 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 53201-3

10、005 Web site http:/www.asq.org Standards Group on QEDS web site 800-248-1946 http:/standardsgroup.asq.org STD-ASQ Q7000-3-ENGL L777 m 0757506 0002423 Lb5 I ANSI/ISO/ASQ Q9000-3- 1997 Contents Page 1 Scope . 1 2 Normative references 2 . 1 3 Definitions 2 i 4 Quality system requirements 2 4.1 Manageme

11、nt responsibility . 2 4.2 Quality system 3 4.3 Contract review . 4 4.4 Designcontrol 5 4.5 Document and data control . 11 4.6 Purchasing 12 4.7 Control of customer-supplied product . 13 4.8 Product identification and traceability . 13 4.9 Process control 14 4.10 Inspection and testing . 16 4.11 Cont

12、rol of inspection, measuring and test equipment 18 4.12 Inspection and test status 19 4.13 Control of nonconforming product . 19 4.14 Corrective and preventive action . 20 4.15 Handling. storage. packaging. preservation and delivery 21 4.16 Control of quality records 22 4.17 Internal quality audits

13、. 22 4.18 Training . 23 4.19 Servicing 23 4.20 Statistical techniques . 24 Annex A Bibliography 27 Annex B Cross-references to ANSI/IEEE/EIA 12207.0 29 . 111 Foreword (This Foreword is not a part of American National Standard ANSI/ISO/ASQ 49000-3, Quality management and quality assurance standards-P

14、art 3: Guidelines for the application of ANSI/ISO/ASQC Q9001-1994 to the devel- opment, supply, installation and maintenance of computer software.) IS0 (the International Organization for Standardization) is a worldwide federation of national standards bodies (IS0 member bodies. The work of preparin

15、g 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 the right to be represented on that committee. International organizations, governmental and nongovernmental, in lia

16、ison with ISO, also take part in the work. IS0 collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publicati

17、on as an International Standard requires approval by at least 75% of the member bodies casting a vote. International Standard IS0 9000-3 was prepared by Technical Committee ISO/TC 176, Quality management ana quality assurance, Subcommittee SC 2, Quality systems. This second edition cancels and repla

18、ces the first edition (IS0 9000-3:1991, which has been technically revised. IS0 9000 consists of the following parts, under the general title Quality management and quality assurance standards: -Part 1: Guidelines for selection and use -Part 2: Generic guidelines for the application of IS0 9001, IS0

19、 9002 and IS0 9003 -Part 3: Guidelines for the application of IS09001:1994 to the development, supply, installation and maintenance of computer software -Part 4: Guide to dependability programme management. Annexes A and B of this part of IS0 9000 are for information only. Comments concerning this s

20、tandard 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 E. Wisconsin Ave., Milwaukee, W1 53202. V Introduction This part of ANSI/ISO/ASQC Q9000 provides guidance in applying the requir

21、ements of ANSI/ISO/ASQC Q9001- 1994 where computer software design, development, installation and maintenance are an element of the business of a supplier: a) as part of a commercial contract with an external organization; b) as a product available for a market sector; c) in support of the business

22、processes of the supplier, d) as software embedded in a hardware product. It identifies the issues which need to be addressed and is independent of the technology, life cycle models, devel- opment processes, sequence of activities, or organization structure used by a supplier. Where the scope of an

23、organizations activities includes areas other than computer software development, the rela- tionship between the computer software elements of that organizations quality system and the remaining aspects should be clearly documented within the quality system as a whole. This part of ANSI/ISO/ASQC 900

24、0 provides guidelines for the application of ANSI/ISO/ASQC Q9001-1994. Where text has been quoted from ANSI/ISO/ASQC Q9001-1994, that text is enclosed in a box, for ease of iden- tification. Throughout this part of ANSI/ISO/ASQC Q9000, “shall” is used to express a provision that is binding between t

25、wo or more parties; “will” to express a declaration of purpose, or intent, of one party; “should to express a recom- mendation among possibilities; and “may” to indicate a course of action permissible within the limits of this part of ANSI/ISO/ASQC Q9000. vi I ANSI/ISO/ASQ Q9000-3- 1997 QUALITY MANA

26、GEMENT AND QUALITY ASSURANCE STANDARDS- PART 3: GUIDELINES FOR THE APPLICATION OF ANSI/ISO/ASQC MAINTENANCE OF COMPUTER SOFTWARE Q9001-1994 TO THE DEVELOPMENT, SUPPLY, INSTALLATION AND 1 SCOPE This part of ANSI/ISO/ASQC Q9000 sets out guide- lines to facilitate the application of ANSI/ISO/ASQC 4900

27、1 - 1994 for organizations developing, supplying, installing and maintaining computer software. It does not add to, or otherwise change, the requirements of ANSI/ISO/ASQC Q9001- 1994. This part of IS0 9000 is not intended to be used as assessment criteria in quality system registratiodcerti- ficatio

28、n. 2 NORMATIVE REFERENCES The following standards contain provisions which, through reference in this text, constitute provisions of this part of ANSI/ISO/ASQC 49000. At the time of publication, the editions indicated were valid. All stan- dards are subject to revision, and parties to agreements bas

29、ed on this part of ANSI/ISO/ASQC 49000 are encouraged to investigate the possibility of applying the most recent edition of the standards indicated below. Members of IEC and IS0 maintain registers of currently valid International Standards. ANSI/ISO/ASQC AS402- 1994, Quality management and quality a

30、ssurance-Vocabulav. ANSI/ISO/ASQC Q9001- 1994, Quality systems- Model for quality assurance in design, development, production, installation and servicing. 3 DEFINITIONS For the purposes of this part of ANSI/ISO/ASQC 49000, the definitions given in ANSI/ISO/ASQC AS402 and the following definitions a

31、pply. 3.1 product: Result of activities or processes. NOTE 1 A product may include service, hardware, processed materials, software 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

32、. NOTE 3 For the purposes of this International Standard, the term “product” applies to the intended product offering only and not to unintended “by-prod- ucts” affecting the environment. This differs from the definition given in ANSI/ISO/ASQC AS402. ANSI/ISO/ASQC Q90011 3.2 tender: Offer made by a

33、supplier in response to an invitation to satisfy a contract award to provide product. ANSI/ISO/ASQC Q90011 3.3 contract: Agreed requirements between a sup- plier and customer transmitted by any means. ANSI/ISO/ASQC Q90011 3.4 baseline: A formally approved version of a con- figuration item, regardles

34、s of media, formally desig- nated and fixed at a specific time during the configuration items life cycle. ANSI/IEEE/EIA 12207.01 3.5 development: Software life cycle process that comprises the activities of requirements analysis, design, coding, integration, testing, installation and support for acc

35、eptance of software products. 3.6 life cycle model: A framework containing the processes, activities, and tasks involved in the develop- ment, operation, and maintenance of a software prod- uct, spanning the life of the system from the definition of its requirements to the termination of its use. AN

36、SI/IEEE/EIA 12207.01 3.7 phase: Defined segment of work. NOTE-A phase does not imply the use of any spe- cific life cycle model. 3.8 regression testing: Testing to determine that changes made in order to correct defects have not introduced additional defects. 1 ANSI/ISO/ASQ 49000-3-1997 3.9 replicat

37、ion: Copying a software product from one medium to another. 3.10 software: See software product (3.1 1). NOTE-In this part of ANSI/ISO/ASQC Q9000, the term “software” is confined to computer software. 3.11 software product: The set of computer pro- grams, procedures, and possibly associated documen-

38、 tation and data. ANSI/IEEE/EIA 12207.01 NOTE-A software product may be designated for delivery, an integral part of another product, or used in the development process. 3.12 software item: Any identifiable part of a soft- ware product. 4 QUALITY SYSTEM REQUIREMENTS 4.1 Management responsibility 4.1

39、.1 Quality policy The suppliers management with executive responsi- bility shall define and document its policy for quality including objectives for quality and its commitment to quality. The quality policy shall be relevant to the suppliers organizational goals and the expectations and needs of its

40、 customers, The supplier shall ensure that this policy is understood, implemented and maintained at all levels of the organization. No further software-related guidance is provided. 4.1.2 Organization 4.1.2.1 Responsibility and authority The responsibility, authority and the interrelation of personn

41、el who manage, perform and verify work affecting quality shall be defined and documented, particularly for personnel who need the organiza- tional freedom and authority to: a) initiate action to prevent the occurrence of any nonconformities relating to product, process and quality system; b) identif

42、y and record any problems relating to the product, process and quality system; c) initiate, recommend or provide solutions through designated channels; I d) verify the implementation of solutions; e) control further processing, delivery or installa- tion of nonconforming product until the defi- cien

43、cy or unsatisfactory condition has been corrected. No further software-related guidance is provided. 4.1.2.2 Resources The supplier shall identify resource requirements and provide adequate resources, including the assignment of trained personnel (see 4.18), for management, performance of work and v

44、erification activities including internal quality audits. No further software-related guidance is provided. NOTE-For further information see ANSI/IEEE/EIA 12207.0, subclause 7.2. 4.1.2.3 Management representative The suppliers management with executive respon- sibility shall appoint a member of the

45、suppliers own management who, irrespective of other respon- sibilities, shall have defined authority for: a) ensuring that a quality system is established, implemented and maintained in accordance with this International Standard, and; b) reporting on the performance of the quality sys- tem to the s

46、uppliers management for review and as a basis for improvement of the quality system. NOTE 5 The responsibility of a management rep- resentative may also include liaison with external parties on matters relating to the suppliers quality system. No further software-related guidance is provided. NOTE-F

47、or further information, see ANSI/IEEE/EIA 12207.0, subclause 6.3.1.6. 2 4.1.3 Management review The suppliers management with executive responsi- bility shall review the quality system at defined inter- vals sufficient to ensure its continuing suitability and effectiveness in satisfying the requirem

48、ents of this International Standard and the suppliers stated qual- ity policy and objectives (see 4.1.1). Records of such reviews shall be maintained (see 4.16). No further software-related guidance is provided. NOTE-For further information, see ANSI/IEEE/EIA 12207.0, subclause 7.1.4. 4.2 Quality sy

49、stem 4.2.1 General The supplier shall establish, document and maintain a quality system as a means of ensuring that product conforms to specified requirements. The supplier shall prepare a quality manual covering the require- ments of this International Standard. The quality manual shall include or make reference to the qual- ity system procedures and outline the structure of the documentation used in the quality system. NOTE 6 Guidance on quality manuals is given in ANSI/ISO/ASQC Q 1 O0 13. No further software-related guidance is provided. 4.2.2 Qualify system proced