ISO9004业绩改进指南.PDF

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1、National Standard of CanadaCAN/CSA-ISO 9004-00(ISO 9004:2000)International Standard ISO 9004:2000 (second edition, 2000-12-15) has been adopted withoutmodification as CSA Standard CAN/CSA-ISO 9004-00, which has been approved as a National Standardof Canada by the Standards Council of Canada.ISBN 1-5

2、5324-407-9December 2000? ? ? ? ?The Canadian Standards Association, whichoperates under the name CSA International(CSA), under whose auspices this National Standardhas been produced, was chartered in 1919 andaccredited by the Standards Council of Canada to theNational Standards system in 1973. It is

3、 a not-for-profit,nonstatutory, voluntary membership associationengaged in standards development and certificationactivities. CSA standards reflect a national consensus ofproducers and users including manufacturers,consumers, retailers, unions and professionalorganizations, and governmental agencies

4、. Thestandards are used widely by industry and commerceand often adopted by municipal, provincial, and federalgovernments in their regulations, particularly in thefields of health, safety, building and construction, andthe environment. Individuals, companies, and associations acrossCanada indicate t

5、heir support for CSAs standardsdevelopment by volunteering their time and skills toCSA Committee work and supporting the Associationsobjectives through sustaining memberships. The morethan 7000 committee volunteers and the 2000sustaining memberships together form CSAs totalmembership from which its

6、Directors are chosen. Sustaining memberships represent a major source ofincome for CSAs standards development activities. The Association offers certification and testing servicesin support of and as an extension to its standardsdevelopment activities. To ensure the integrity of itscertification pro

7、cess, the Association regularly andcontinually audits and inspects products that bear theCSA Mark. In addition to its head office and laboratory complexin Toronto, CSA has regional branch offices in majorcentres across Canada and inspection and testingagencies in eight countries. Since 1919, the Ass

8、ociationhas developed the necessary expertise to meet itscorporate mission: CSA is an independent serviceorganization whose mission is to provide an open andeffective forum for activities facilitating the exchange ofgoods and services through the use of standards,certification and related services t

9、o meet national andinternational needs.For further information on CSA services, write toCSA International178 Rexdale BoulevardToronto, Ontario, M9W 1R3CanadaThe Standards Council of Canada is thecoordinating body of the National Standards system, a federation of independent, autonomousorganizations

10、working towards the furtherdevelopment and improvement of voluntarystandardization in the national interest. The principal objects of the Council are to foster and promote voluntary standardization as a means of advancing the national economy, benefiting thehealth, safety, and welfare of the public,

11、 assisting and protecting the consumer, facilitating domestic and international trade, and furthering internationalcooperation in the field of standards. A National Standard of Canada is a standard whichhas been approved by the Standards Council ofCanada and one which reflects a reasonableagreement

12、among the views of a number of capableindividuals whose collective interests provide to thegreatest practicable extent a balance ofrepresentation of producers, users, consumers, andothers with relevant interests, as may be appropriateto the subject in hand. It normally is a standardwhich is capable

13、of making a significant and timelycontribution to the national interest. Approval of a standard as a National Standard ofCanada indicates that a standard conforms to thecriteria and procedures established by the StandardsCouncil of Canada. Approval does not refer to thetechnical content of the stand

14、ard; this remains thecontinuing responsibility of the accreditedstandards-development organization. Those who have a need to apply standards areencouraged to use National Standards of Canadawhenever practicable. These standards are subject to periodic review; therefore, users are cautioned to obtain

15、 the latest edition from the organizationpreparing the standard.The responsibility for approving National Standards of Canada rests with theStandards Council of Canada270 Albert Street, Suite 200Ottawa, Ontario, K1P 6N7CanadaLes normes nationales du Canada sont publies en versions franaise et anglai

16、se.Although the intended primary application of this Standard is stated in its Scope, it is importantto note that it remains the responsibility of the users to judge its suitability for their particular purpose.Quality management systems CAN/CSA-ISO 9004-00Guidelines for performance improvementsDece

17、mber 2000CSA/1CAN/CSA-ISO 9004-00Quality management systems Guidelines for performanceimprovementsCSA PrefaceThis is the first edition of CSA Standard CAN/CSA-ISO 9004, Quality management systems Guidelinesfor performance improvements, which is an adoption without modification of the identically tit

18、led ISO(International Organization for Standardization) Standard 9004:2000 (second edition, 2000-12-15). ThisCSA Standard supersedes CSA Standard CAN/CSA-ISO 9004-1-94 (adopted ISO 9004-1:1994), Qualitymanagement and quality system elements, Part 1: Guidelines. The ISO 9000 and ISO 10000 family of S

19、tandards was developed by quality experts from around theworld, under the auspices of the International Organization for Standardization (ISO) TechnicalCommittee 176. Canada plays a major role in this area. The technical committee is chaired by aCanadian. The Secretariat of ISO/TC 176 is held by CSA

20、 on behalf of Canadas member body in ISO, theStandards Council of Canada. Canadian stakeholders participate actively in the administration and development of the ISO 9000 andISO 10000 family of International Standards, through CSAs forum for national consensus in thedevelopment of Standards. The CSA

21、 Technical Committee on Quality Management is the source ofCanadian experts and public input for the ISO 9000 and ISO 10000 Standards. In its capacity as theCanadian Advisory Committee to ISO/TC 176 (CAC/ISO/TC 176), the Technical Committee isresponsible for(a) developing and submitting coordinated

22、Canadian responses, comments, and voting actions onISO/TC 176 documents;(b) developing and submitting Canadian proposals for new international work items;(c) recommending the Canadian delegates to participate in international meetings of ISO/TC 176, itsSubcommittees and Working groups; and(d) recomm

23、ending the Canadian position for delegates to take in international meetings In proposing this International Standard for adoption as a National Standard of Canada, the CSATechnical Committee on Quality Management (CAC/ISO/TC 176) has approved the technical content ofthis Standard, and supports it o

24、n a continuing basis, providing interpretations, updates and revisions,and reaffirmations or withdrawals, as appropriate for Canadian stakeholders. This Standard was reviewed for Canadian adoption by the CSA Technical Committee on QualityManagement (CAC/ISO/TC 176), under the jurisdiction of the Str

25、ategic Steering Committee on BusinessManagement Systems, and was formally approved by the Technical Committee. A list of the membersof the Technical Committee is available upon request. This Standard has been approved as a NationalStandard of Canada by the Standards Council of Canada.December 2000 C

26、SA International 2000All rights reserved. No part of this publication may be reproduced in any form whatsoever without the priorpermission of the publisher. ISO material is reprinted with permission. Inquiries regarding this NationalStandard of Canada should be addressed to CSA International, 178 Re

27、xdale Boulevard, Toronto, Ontario, CanadaINTERNATIONALSTANDARDISO9004Second edition2000-12-15Reference numberISO 9004:2000(E) ISO 2000Quality management systems Guidelinesfor performance improvementsSystmes de management de la qualit Lignes directrices pourlamlioration des performancesISO 9004:2000(

28、E)ii ISO 2000 All rights reservedPDF disclaimerThis PDF file may contain embedded typefaces. In accordance with Adobes licensing policy, this file may be printed or viewed but shall not beedited unless the typefaces which are embedded are licensed to and installed on the computer performing the edit

29、ing. In downloading this file,parties accept therein the responsibility of not infringing Adobes licensing policy. The ISO Central Secretariat accepts no liability in this area.Adobe is a trademark of Adobe Systems Incorporated.Details of the software products used to create this PDF file can be fou

30、nd in the General Info relative to the file; the PDF-creation parameterswere optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely eventthat a problem relating to it is found, please inform the Central Secretariat at the a

31、ddress given below. ISO 2000All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, elec-tronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or I

32、SOs mem-ber body in the country of the requester.ISO copyright officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.chWeb www.iso.chISO 9004:2000(E) ISO 2000 All rights reservediiiContentsPage1Scope .12Normative reference .13Terms and definitions .14Q

33、uality management system .24.1Managing systems and processes .24.2Documentation .34.3Use of quality management principles .45Management responsibility .55.1General guidance .55.2Needs and expectations of interested parties .75.3Quality policy .95.4Planning .105.5Responsibility, authority and communi

34、cation .115.6Management review .126Resource management .146.1General guidance .146.2People .156.3Infrastructure .176.4Work environment .186.5Information .186.6Suppliers and partnerships .196.7Natural resources .196.8Financial resources .197Product realization .207.1General guidance .207.2Processes r

35、elated to interested parties .237.3Design and development .247.4Purchasing .297.5Production and service operations .317.6Control of measuring and monitoring devices .338Measurement, analysis and improvement .348.1General guidance .348.2Measurement and monitoring .358.3Control of nonconformity .408.4

36、Analysis of data .418.5Improvement .42ISO 9004:2000(E)iv ISO 2000 All rights reservedAnnexesAGuidelines for self-assessment.46BProcess for continual improvement.53Bibliography.55ISO 9004:2000(E) ISO 2000 All rights reservedvForewordISO (the International Organization for Standardization) is a worldw

37、ide federation of national standards bodies (ISOmember bodies). The work of preparing International Standards is normally carried out through ISO technicalcommittees. Each member body interested in a subject for which a technical committee has been established hasthe right to be represented on that

38、committee. International organizations, governmental and non-governmental, inliaison with ISO, also take part in the work. ISO collaborates closely with the International ElectrotechnicalCommission (IEC) on all matters of electrotechnical standardization.International Standards are drafted in accord

39、ance with the rules given in the ISO/IEC Directives, Part 3.Draft 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.Attention is dr

40、awn to the possibility that some of the elements of this International Standard may be the subject ofpatent rights. ISO shall not be held responsible for identifying any or all such patent rights.International Standard ISO 9004 was prepared by Technical Committee ISO/TC 176,Quality management andqua

41、lity assurance, Subcommittee SC 2,Quality systems.This second edition of ISO 9004 cancels and replaces ISO 9004-1:1994, which has been technically revised. Thetitle has been modified to reflect the comprehensiveness of the quality management system. Many of the existingInternational Standards within

42、 the ISO 9000 family will be reviewed for withdrawal, or for re-issue as TechnicalReports, as many of their provisions are incorporated into this International Standard.In comparison to previous editions, ISO 9001 and ISO 9004 now form a consistent pair of standards on qualitymanagement. ISO 9001 ai

43、ms to give quality assurance of product and to enhance customer satisfaction, whileISO 9004 uses a broader perspective of quality management to give guidance for performance improvement.Annexes A and B of this International Standard are for information only.ISO 9004:2000(E)vi ISO 2000 All rights res

44、ervedIntroduction0.1GeneralThe adoption of a quality management system should be a strategic decision by the top management of anorganization. The design and implementation of an organizations quality management system is influenced byvarying needs, particular objectives, the products provided, the

45、processes employed and the size and structure of theorganization. This International Standard is based on eight quality management principles. However, it is not theintent of this International Standard to imply uniformity in the structure of quality management systems or uniformityof documentation.

46、The purpose of an organization is to identify and meet the needs and expectations of its customers and other interested parties (people in theorganization, suppliers, owners, society), to achieve competitive advantage, and to do this in an effective andefficient manner, and to achieve, maintain, and

47、 improve overall organizational performance and capabilities.The application of quality management principles not only provides direct benefits but also makes an importantcontribution to managing costs and risks. Benefit, cost and risk management considerations are important for theorganization, its

48、 customers and other interested parties. These considerations on overall performance of theorganization may impact customer loyalty, repeat business and referral, operational results such as revenue and market share, flexible and fast responses to market opportunities, costs and cycle times through

49、effective and efficient use of resources, alignment of processes which will best achieve desired results, competitive advantage through improved organizational capabilities, understanding and motivation of people towards the organizations goals and objectives, as well as participationin continual im

50、provement, confidence of interested parties in the effectiveness and efficiency of the organization, as demonstrated by thefinancial and social benefits from the organizations performance, product life cycle, and reputation, ability to create value for both the organization and its suppliers by opti