ASQ Q9001 EXCERPTED-2000 Excerpted Version Quality management systems - Requirements (An abridged document for auditors) (T2200P).pdf

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1、Excerpted Version:Quality management systemsRequirements(An abridged document for auditors)AMERICAN SOCIETY FOR QUALITYP.O. BOX 3005MILWAUKEE, WISCONSIN 53201-3005Excerpted Version:Quality management systemsRequirements(An abridged document for auditors)2001 by ASQCopyright Protection Notice for the

2、 ANSI/ISO/ASQQ9000-2000 Standard.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, includingan electronic retrieval system, without the prior writtenpermission of ASQ. All requests pertaining to theANSI/ISO/A

3、SQ Q9000-2000 Standard should be submitted to ASQ.Note: As used in this document, the term “InternationalStandard“ refers to the American National Standardadoption of this and other International Standards.ASQ will consider requests for change and informationon the submittal of such requests regardi

4、ng thisStandard. All requests should be in writing to the attention of the Standards administrator at the address below.ASQ Mission: The American Society for Qualityadvances individual and organizational performanceexcellence worldwide by providing opportunities forlearning, quality improvement, and

5、 knowledgeexchange.Quality PressP. O. Box 3005Milwaukee, Wisconsin 53201-3005800-248-1946Fax: 414-272-1734www.asq.orghttp:/qualitypress.asq.orghttp:/standardsgroup.asq.orgPublished by:Additional resources on the ANSI/ISO/ASQ Q9000-2000 Standards available from ASQ Quality Press:ISO 9001:2000 Explain

6、ed, Second EditionCharles A. Cianfrani, Joseph J. Tsiakals, and John E.(Jack) WestThe ISO Lesson Guide 2000: Pocket Guide toQ9001:2000, Second EditionDennis Arter and J. P. RussellISO 9001:2000 An Audio Workshop and MasterSlide PresentationJohn E. (Jack) West and Charles A. CianfraniISO 9001:2000 Qu

7、ick ReferenceJeanne Ketola and Kathy RobertsISO 9000 at the Front LineWilliam A. LevinsonAfter the Quality Audit: Closing the Loop on the AuditProcess, Second EditionJ. P. Russell and Terry RegelInternal Quality AuditingDenis PronovostQuality Press has created an ISO 9000:2000Resource Materials Web

8、page. This convenient online resource contains links to all the books, journals, standards, and courses that are availablethrough ASQ (as well as general information andFAQs) on this important revision to the standards.You can visit this page from our Online Bookstore athttp:/qualitypress.asq.org .T

9、o request a complimentary catalog of ASQ QualityPress publications, call 800-248-1946, or visit ourOnline Bookstore at http:/qualitypress.asq.org .ForewordThis document was designed form customer feedbackwhich indicated a desire by some in the auditing commu-nity to have a compact version of just th

10、e quality man-agement system requirements contained in theANSI/ISO/ASQ Q9001-2000.It is not intended to be used as a standard. Those wish-ing the full content of the standard should use theunabridged ANSI/ISO/ASQ Q9001-2000. Those needingclarification of the concepts and terminology contained inthis

11、 or the full standard should use the ANSI/ISO/ASQQ9000-2000.4 Quality management system4.1 General requirementsThe organization shall establish, document, implementand maintain a quality management system and continually improve its effectiveness in accordancewith the requirements of this Internatio

12、nal Standard.The organization shalla) identify the processes needed for the qualitymanagement system and their application throughoutthe organization (see 1.2),b) determine the sequence and interaction of theseprocesses,c) determine criteria and methods needed to ensurethat both the operation and co

13、ntrol of these processesare effective,d) ensure the availability of resources and informa-tion necessary to support the operation and monitoringof these processes,e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve plannedresults and continual improvement o

14、f these processes.These processes shall be managed by the organiza-tion in accordance with the requirements of thisInternational Standard.Where an organization chooses to outsource anyprocess that affects product conformity with require-ments, the organization shall ensure control over suchprocesses

15、. Control of such outsourced processes shallbe identified within the quality management system.NOTE Processes needed for the quality managementsystem referred to above should include processes formanagement activities, provision of resources, productrealization and measurement.4.2 Documentation requ

16、irements4.2.1 GeneralThe quality management system documentation shallincludea) documented statements of a quality policy andquality objectives,b) a quality manual,c) documented procedures required by thisInternational Standard, d) documents needed by the organization to ensurethe effective planning

17、, operation and control of itsprocesses, and1e) records required by this International Standard(see 4.2.4).NOTE 1 Where the term “documented procedure“appears within this International Standard, this meansthat the procedure is established, documented, imple-mented and maintained.NOTE 2 The extent of

18、 the quality management system documentation can differ from one organizationto another due toa) the size of organization and type of activities,b) the complexity of processes and their interac-tions, andc) the competence of personnel.NOTE 3 The documentation can be in any form ortype of medium.4.2.

19、2 Quality manualThe organization shall establish and maintain a qualitymanual that includesa) the scope of the quality management system,including details of and justification for any exclusions(see 1.2),b) the documented procedures established for thequality management system, or reference to them,

20、 andc) a description of the interaction between theprocesses of the quality management system.4.2.3 Control of documentsDocuments required by the quality management sys-tem shall be controlled. Records are a special type ofdocument and shall be controlled according to therequirements given in 4.2.4.

21、A documented procedure shall be established todefine the controls neededa) to approve documents for adequacy prior toissue,b) to review and update as necessary and re-approve documents,c) to ensure that changes and the current revisionstatus of documents are identified,d) to ensure that relevant ver

22、sions of applicable doc-uments are available at points of use,e) to ensure that documents remain legible andreadily identifiable,2f) to ensure that documents of external origin areidentified and their distribution controlled, andg) to prevent the unintended use of obsolete docu-ments, and to apply s

23、uitable identification to them ifthey are retained for any purpose.4.2.4 Control of recordsRecords shall be established and maintained to pro-vide evidence of conformity to requirements and of theeffective operation of the quality management system.Records shall remain legible, readily identifiable

24、andretrievable. A documented procedure shall be estab-lished to define the controls needed for the identifica-tion, storage, protection, retrieval, retention time anddisposition of records.5 Management responsibility5.1 Management commitmentTop management shall provide evidence of its commit-ment to

25、 the development and implementation of thequality management system and continually improvingits effectiveness bya) communicating to the organization the impor-tance of meeting customer as well as statutory andregulatory requirements,b) establishing the quality policy,c) ensuring that quality object

26、ives are established,d) conducting management reviews, ande) ensuring the availability of resources.5.2 Customer focusTop management shall ensure that customer require-ments are determined and are met with the aim ofenhancing customer satisfaction (see 7.2.1 and 8.2.1).5.3 Quality policyTop manageme

27、nt shall ensure that the quality policya) is appropriate to the purpose of the organization,b) includes a commitment to comply with require-ments and continually improve the effectiveness of thequality management system,c) provides a framework for establishing and review-ing quality objectives,d) is

28、 communicated and understood within theorganization, ande) is reviewed for continuing suitability.35.4 Planning5.4.1 Quality objectivesTop management shall ensure that quality objectives,including those needed to meet requirements for prod-uct see 7.1 a), are established at relevant functionsand lev

29、els within the organization. The quality objec-tives shall be measurable and consistent with the qual-ity policy.5.4.2 Quality management system planningTop management shall ensure thata) the planning of the quality management system iscarried out in order to meet the requirements given in4.1, as we

30、ll as the quality objectives, andb) the integrity of the quality management system ismaintained when changes to the quality managementsystem are planned and implemented.5.5 Responsibility, authority and communication5.5.1 Responsibility and authorityTop management shall ensure that responsibilities

31、andauthorities are defined and communicated within theorganization.5.5.2 Management representativeTop management shall appoint a member of manage-ment who, irrespective of other responsibilities, shallhave responsibility and authority that includesa) ensuring that processes needed for the qualityman

32、agement system are established, implementedand maintained,b) reporting to top management on the performanceof the quality management system and any need forimprovement, andc) ensuring the promotion of awareness of customerrequirements throughout the organization.NOTE The responsibility of a manageme

33、nt represen-tative can include liaison with external parties on mat-ters relating to the quality management system.5.5.3 Internal communicationTop management shall ensure that appropriate com-munication processes are established within theorganization and that communication takes placeregarding the

34、effectiveness of the quality managementsystem.45.6 Management review5.6.1 GeneralTop management shall review the organizations quali-ty management system, at planned intervals, to ensureits continuing suitability, adequacy and effectiveness.This review shall include assessing opportunities forimprov

35、ement and the need for changes to the qualitymanagement system, including the quality policy andquality objectives.Records from management reviews shall be main-tained (see 4.2.4).5.6.2 Review inputThe input to management review shall include informa-tion ona) results of audits,b) customer feedback,

36、c) process performance and product conformity,d) status of preventive and corrective actions,e) follow-up actions from previous managementreviews,f) changes that could affect the quality managementsystem, andg) recommendations for improvement.5.6.3 Review outputThe output from the management review

37、shall includeany decisions and actions related toa) improvement of the effectiveness of the qualitymanagement system and its processes,b) improvement of product related to customerrequirements, andc) resource needs.6 Resource management6.1 Provision of resourcesThe organization shall determine and p

38、rovide theresources neededa) to implement and maintain the quality managementsystem and continually improve its effectiveness, andb) to enhance customer satisfaction by meeting cus-tomer requirements.56.2 Human resources6.2.1 GeneralPersonnel performing work affecting product qualityshall be compete

39、nt on the basis of appropriate educa-tion, training, skills and experience.6.2.2 Competence, awareness and trainingThe organization shalla) determine the necessary competence for person-nel performing work affecting product quality,b) provide training or take other actions to satisfythese needs,c) e

40、valuate the effectiveness of the actions taken,d) ensure that its personnel are aware of the relevanceand importance of their activities and how they contributeto the achievement of the quality objectives, ande) maintain appropriate records of education, training, skills and experience (see 4.2.4).6

41、.3 InfrastructureThe organization shall determine, provide and maintainthe infrastructure needed to achieve conformity toproduct requirements. Infrastructure includes, as applicablea) buildings, workspace and associated utilities,b) process equipment (both hardware and software), andc) supporting se

42、rvices (such as transport or communication).6.4 Work environmentThe organization shall determine and manage thework environment needed to achieve conformity toproduct requirements.7 Product realization7.1 Planning of product realizationThe organization shall plan and develop the processesneeded for

43、product realization. Planning of productrealization shall be consistent with the requirements ofthe other processes of the quality management system(see 4.1).In planning product realization, the organization shalldetermine the following, as appropriate:a) quality objectives and requirements for the

44、product;b) the need to establish processes, documents, andprovide resources specific to the product;6c) required verification, validation, monitoring,inspection and test activities specific to the productand the criteria for product acceptance;d) records needed to provide evidence that the realizati

45、on processes and resulting product meetrequirements (see 4.2.4).The output of this planning shall be in a form suitablefor the organizations method of operations.NOTE 1 A document specifying the processes of thequality management system (including the productrealization processes) and the resources

46、to be appliedto a specific product, project or contract, can bereferred to as a quality plan.NOTE 2 The organization may also apply the require-ments given in 7.3 to the development of product realization processes.7.2 Customer-related processes7.2.1 Determination of requirements related to theprodu

47、ctThe organization shall determinea) requirements specified by the customer, includingthe requirements for delivery and post-delivery activities,b) requirements not stated by the customer but necessary for specified or intended use, where known,c) statutory and regulatory requirements related tothe

48、product, andd) any additional requirements determined by theorganization.7.2.2 Review of requirements related to the productThe organization shall review the requirements relatedto the product. This review shall be conducted prior tothe organizations commitment to supply a product tothe customer (e.

49、g. submission of tenders, acceptanceof contracts or orders, acceptance of changes to con-tracts or orders) and shall ensure thata) product requirements are defined,b) contract or order requirements differing fromthose previously expressed are resolved, andc) the organization has the ability to meet thedefined requirements.Records of the results of the review and actions arisingfrom the review shall be maintained (see 4.2.4).Where the customer provides no documented state-ment of requirement, the customer requirements shallbe confirmed by t