ASQ Q10005-2005 Quality management systems Guidelines for quality plans (T815E)《质量计划指导方针质量管理系统》.pdf

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1、 AMERICAN NATIONAL STANDARD Quality management systems Guidelines for quality plans AMERICAN SOCIETY FOR QUALITY P.O. BOX 3005 MILWAUKEE, WI 53201-3005 ANSI/ISO/ASQ Q10005-2005AMERICAN NATIONAL STANDARD Quality management systems Guidelines for quality plans Approved as an American National Standard

2、 by: American Society for Quality May 11, 2006 American National Standards: An American National Standard implies a consensus of those substantially concerned with is scope and provisions. An American National Standard is intended as a guide to aid the manufacturer, the consumer, and the general pub

3、lic. 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 peri

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 Caution Notice: This American National Standard may be revised or withdrawn at any time.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

5、than five years from the date of publication. Purchasers of American National Standards may receive current information on all standards by calling of writing the American National Standards Institute. ANSI/ISO/ASQ Q10005-2005 2006 by ASQCopyright Protection Notice for the ANSI/ISO/ASQ Q10005-2005 S

6、tandard.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 Q10005-2005 Standa

7、rd should be submitted to ASQ.Note: As used in this document, the term “International 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.

8、 All requests should be in writing to the attention of the Standards administrator 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 ex

9、change.Published by:ANSI/ISO/ASQ Q10005-2005Also available from ASQ Quality Press: The Certified Manager of Quality/Organizational Excellence Handbook, Third Edition Russell T. Westcott, editor The Quality Toolbox, Second Edition Nancy R. Tague The Quality Improvement Handbook, Second Edition ASQ Qu

10、ality Management Division and John E. Bauer, Grace L. Duffy, Russell T. Westcott, editors Making Change Work: Practical Tools for Overcoming Human Resistance to Change Brien Palmer Business Performance through Lean Six Sigma: Linking the Knowledge Worker, the Twelve Pillars, and Baldrige James T. Sc

11、hutta How to Audit the Process-Based QMS Dennis R. Arter, Charles A. Cianfrani, and John E. (Jack) West Unlocking the Power of Your QMS: Keys to Business Performance Improvement John E. (Jack) West and Charles A. Cianfrani Root Cause Analysis: Simplified Tools and Techniques, Second Edition Bjrn And

12、ersen and Tom Fagerhaug The Practical Guide to People-Friendly Documentation Adrienne Escoe, Ph.D. Avoiding the Corporate Death Spiral: Recognizing and Eliminating the Signs of Decline Gregg Stocker To request a complimentary catalog of ASQ Quality Press publications, call 800-248-1946, or visit our

13、 Web site at http:/qualitypress.asq.org. ANSI/ISO/ASQ Q10005-2005(This page is intentionally left blank.) iiiContents Page1 Scope 12 Normative references 13 Terms and definitions 14 Development of a quality plan 34.1 Identifying the need for the quality plan . 34.2 Inputs to the quality plan 44.3 Sc

14、ope of the quality plan 44.4 Preparation of the quality plan . 45 Content of the quality plan . 55.1 General . 55.2 Scope 65.3 Quality plan inputs 65.4 Quality objectives 65.5 Management responsibilities . 65.6 Control of documents and data . 65.7 Control of records . 75.8 Resources 75.9 Requirement

15、s 85.10 Customer communication 85.11 Design and development 85.12 Purchasing . 95.13 Production and service provision 95.14 Identification and traceability . 105.15 Customer property 105.16 Preservation of product 105.17 Control of nonconforming product 115.18 Monitoring and measurement 115.19 Audit

16、s . 116 Review, acceptance, implementation and revision of the quality plan . 126.1 Review and acceptance of the quality plan 126.2 Implementation of the quality plan 126.3 Revision of the quality plan 136.4 Feedback and improvement . 13Annex A (informative) Simplified examples of formats for the pr

17、esentation of quality plans 14Annex B (informative) Correspondence between ISO 10005:2005 and ISO 9001:2000 . 22Bibliography . 23ANSI/ISO/ASQ Q10005-2005ivForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies(ISO member bodies). The w

18、ork of preparing International Standards is normally carried out through ISOtechnical committees. 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-governmen

19、tal, in liaison with ISO, also take part in the work. ISO collaborates closely with the InternationalElectrotechnical Commission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.The main

20、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 vote.Attentio

21、n is drawn to the possibility that some of the elements of this document may be the subject of patentrights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 10005 was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance,Subcommittee

22、 SC 2, Quality systems.This second edition cancels and replaces the first edition (ISO 10005:1995). It constitutes a technical revision ofthat edition, taking into account ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000.ANSI/ISO/ASQ Q10005-2005vIntroductionThis International Standard was prepared to

23、address the need for guidance on quality plans, either in thecontext of an established quality management system or as an independent management activity. In eithercase, quality plans provide a means of relating specific requirements of the process, product, project or contractto work methods and pr

24、actices that support product realization. The quality plan should be compatible withother associated plans that may be prepared.Among the benefits of establishing a quality plan are the increased confidence that requirements will be met,greater assurance that processes are in control and the motivat

25、ion it can give to those involved. It may also giveinsight into opportunities for improvement.This International Standard does not replace the guidance given in ISO 9004 or in industry-specific documents.Where quality plans are required for project applications, the guidance provided in this Interna

26、tional Standard isintended to be complementary to the guidance provided in ISO 10006.In terms of the process model shown in Figure 1, quality management system planning applies to the wholemodel. Quality plans, however, apply primarily to the path from customer requirements, through productrealizati

27、on and product, to customer satisfaction.Figure 1 Model of a process-based quality management systemANSI/ISO/ASQ Q10005-2005INTERNATIONAL STANDARD ANSI/ISO/ASQ Q10005-20051Quality management systems Guidelines for quality plans1ScopeThis International Standard provides guidelines for the development

28、, review, acceptance, application andrevision of quality plans.It is applicable whether or not the organization has a management system in conformity with ISO 9001.This International Standard is applicable to quality plans for a process, product, project or contract, any productcategory (hardware, s

29、oftware, processed materials and services) and any industry.It is focused primarily on product realization and is not a guide to organizational quality management systemplanning.This International Standard is a guidance document and is not intended to be used for certification orregistration purpose

30、s.NOTE To avoid undue repetition of “process, product, project or contract”, this International Standard uses the term“specific case” (see 3.10).2 Normative referencesThe following referenced documents are indispensable for the application of this document. For datedreferences, only the edition cite

31、d applies. For undated references, the latest edition of the referenced document(including any amendments) applies.ISO 9000:2000, Quality management systems Fundamentals and vocabulary3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 9000 and the follow

32、ing apply. Someof the definitions below are quoted directly from ISO 9000, but notes are in some cases omitted orsupplemented.3.1objective evidencedata supporting the existence or verity of somethingNOTE Objective evidence may be obtained through observation, measurement, test, or other means.ISO 90

33、00:2000, definition 3.8.13.2procedurespecified way to carry out an activity or a process (3.3)NOTE 1 Procedures can be documented or not.NOTE 2 When a procedure is documented, the term “written procedure” or “documented procedure” is frequently used.The document that contains a procedure can be call

34、ed a “procedure document”.ISO 9000:2000, definition 3.4.523.3processset of interrelated or interacting activities which transforms inputs into outputsNOTE Adapted from ISO 9000:2000, definition 3.4.1 (the Notes have not been included).3.4productresult of a process (3.3)NOTE 1 There are four generic

35、product categories, as follows: services (e.g. transport); software (e.g. computer program, dictionary); hardware (e.g. engine mechanical part); processed materials (e.g. lubricant).Many products comprise elements belonging to different generic product categories. Whether the product is then calleds

36、ervice, software, hardware or processed material depends on the dominant element. For example the offered product“automobile” consists of hardware (e.g. tyres), processed materials (e.g. fuel, cooling liquid), software (e.g. engine controlsoftware, drivers manual), and service (e.g. operating explan

37、ations given by the salesman).NOTE 2 Service is the result of at least one activity necessarily performed at the interface between the supplier andcustomer and is generally intangible. Provision of a service can involve, for example, the following: an activity performed on a customer-supplied tangib

38、le product (e.g. automobile to be repaired); an activity performed on a customer-supplied intangible product (e.g. the income statement needed to prepare a taxreturn); the delivery of an intangible product (e.g. the delivery of information in the context of knowledge transmission); the creation of a

39、mbience for the customer (e.g. in hotels and restaurants).Software consists of information and is generally intangible and can be in the form of approaches, transactions orprocedures (3.2)Hardware is generally tangible and its amount is a countable characteristic. Processed materials are generally t

40、angible andtheir amount is a continuous characteristic. Hardware and processed materials often are referred to as goods.ISO 9000:2000, definition 3.4.23.5projectunique process (3.3) consisting of a set of coordinated and controlled activities with start and finish dates,undertaken to achieve an obje

41、ctive conforming to specific requirements, including the constraints of time, costand resourcesNOTE 1 An individual project can form part of a larger project structure.NOTE 2 In some projects, the objectives are refined and the product characteristics defined progressively as the projectproceeds.NOT

42、E 3 The outcome of a project may be one or several units of product (3.4).ISO 9000:2000, definition 3.4.33.6quality management systemmanagement system to direct and control an organization with regard to qualityISO 9000:2000, definition 3.2.3ANSI/ISO/ASQ Q10005-200533.7quality objectivesomething sou

43、ght, or aimed for, related to qualityNOTE 1 Quality objectives are generally based on the organizations quality policy.NOTE 2 Quality objectives are generally specified for relevant functions and levels in the organization.ISO 9000:2000, definition 3.2.53.8quality plandocument specifying which proce

44、sses (3.3), procedures (3.2) and associated resources will be applied bywhom and when, to meet the requirements of a specific project (3.5), product (3.4), process or contractNOTE 1 These procedures generally include those referring to quality management processes and to product realizationprocesses

45、.NOTE 2 A quality plan often makes reference to parts of the quality manual or to procedure documents.NOTE 3 A quality plan is generally one of the results of quality planning.3.9recorddocument stating results achieved or providing evidence of activities performedNOTE Adapted from ISO 9000:2000, def

46、inition 3.7.6 (the Notes have not been included).3.10specific casesubject of the quality plan (3.8)NOTE This term is used to avoid repetition of “process, product, project or contract” within this International Standard.4 Development of a quality plan4.1 Identifying the need for the quality planThe

47、organization should identify what need there may be for quality plans. There are a number of situationswhere quality plans may be useful or necessary, for example:a) to show how the organizations quality management system applies to a specific case;b) to meet statutory, regulatory or customer requir

48、ements;c) in developing and validating new products or processes;d) to demonstrate, internally and/or externally, how quality requirements will be met;e) to organize and manage activities to meet quality requirements and quality objectives;f) to optimize the use of resources in meeting quality objec

49、tives;g) to minimize the risk of not meeting quality requirements;h) to use as a basis for monitoring and assessing compliance with the requirements for quality;i) in the absence of a documented quality management system.NOTE There may or may not be a need to prepare a quality plan for a specific case. An organization with an establishedquality management system may be able to fulfil all of its needs for quality plans under its existing system; the organizationmay then decide that there is no need to prepa