ISO9000-制造业(1)

CrackingtheCaseofISO9001:2000forManufacturingAlsoavailablefromASQQualityPress:ISO9001:2000Explained,SecondEditionCharlesA.Cianfrani,JosephJ.Tsiakals,andJohnE.(Jack)WestTheASQISO9000:2000HandbookCharlesA.Cianfrani,JosephJ.Tsiakals,andJohnE.(Jack)West,editorsCrackingtheCaseofISO9001:2000forServiceCharlesA.CianfraniandJohnE.(Jack)WestISO9001:2000—AnAudioWorkshopandMasterSlideSet,SecondEditionCharlesA.CianfraniandJohnE.(Jack)WestQualityAuditsforISO9001:2000:MakingComplianceValue-AddedTimothyO’HanlonISOLessonGuide2000:PocketGuidetoQ9001:2000,SecondEditionDennisArterandJ.P.RussellISO9000:2000forSmallandMediumBusinessesHerbMonnichThePracticalGuidetoPeople-FriendlyDocumentationAdrienneEscoeTheCertifiedQualityManagerHandbook,SecondEditionDukeOkesandRussellT.Westcott,editorsISO9000:2000QuickReferenceJeanneKetolaandKathyRobertsANSI/ISO/ASQQ9000:2000SeriesQualityStandardsTorequestacomplimentarycatalogofASQQualityPresspublications,call800-248-1946,orvisitourWebsiteat(Jack)WestASQQualityPressMilwaukee,WisconsinCrackingtheCaseofISO9001:2000forManufacturingCharlesA.CianfraniandJohnE.(Jack)WestLibraryofCongressCataloging-in-PublicationDataCianfrani,CharlesA.CrackingthecaseofISO9001:2000formanufacturing/CharlesA.CianfraniandJohnE.(Jack)West.p.cm.Includesbibliographicalreferencesandindex.ISBN0-87389-553-31.Qualitycontrol—Standards.2.ISO9001Standard.I.West,Jack,1944–II.Title.TS156.C722002658.5'62—dc212002009117©2003byASQAllrightsreserved.Nopartofthisbookmaybereproducedinanyformorbyanymeans,electronic,mechanical,photocopying,recording,orotherwise,withoutthepriorwrittenpermissionofthepublisher.10987654321ISBN0-87389-553-3Publisher:WilliamA.TonyAcquisitionsEditor:AnnemiekeKoudstaalProjectEditor:CraigS.PowellProductionAdministrator:GretchenTrautmanSpecialMarketingRepresentative:DeniseM.CawleyASQMission:TheAmericanSocietyforQualityadvancesindividual,organizational,andcommunityexcellenceworldwidethroughlearning,qualityimprovement,andknowledgeexchange.AttentionBookstores,Wholesalers,Schools,andCorporations:ASQQualityPressbooks,videotapes,audiotapes,andsoftwareareavailableatquantitydiscountswithbulkpurchasesforbusiness,educational,orinstructionaluse.Forinformation,pleasecontactASQQualityPressat800-248-1946,orwritetoASQQualityPress,P.O.Box3005,Milwaukee,WI53201-3005.ToplaceordersortorequestafreecopyoftheASQQualityPressPublicationsCatalog,includingASQmembershipinformation,call800-248-1946.VisitourWebsiteat—CustomerFocusandMeasuringSatisfaction........................8ProcessApproach—Activities,ProcessManagement,andtheSystemsApproachtoManagement.....................10TopManagement—ResponsibilityandInvolvement........................13Alignment—QualityObjectives,ProcessMeasurement,andCommunication........14ContinualImprovement..................15Chapter3ImplementingISO9001:2000.........171Scope,1.1General,and1.2Application....202Normativereferenceand3Termsanddefinitions.........................224.1Generalrequirements.................234.2Documentationrequirements,4.2.1General.......................264.2.2Qualitymanual....................274.2.3Controlofdocuments...............294.2.4Controlofrecords..................315.1Managementcommitment..............345.2Customerfocus.....................375.3Qualitypolicy......................385.4.1Qualityobjectives..................415.4.2Qualitymanagementsystemplanning....425.5.1Responsibilityandauthority...........455.5.2Managementrepresentative...........465.5.3Internalcommunication..............485.6Managementreview,5.6.1General.......505.6.2Reviewinput.....................525.6.3Reviewoutput....................546.1Generalrequirements.................566.2Humanresources,6.2.1General........586.2.2Competence,awarenessandtraining....606.3Infrastructure.......................626.4Workenvironment...................637.1Planningofproductrealization..........657.2.1Determinationofrequirementsrelatedtotheproduct.......................687.2.2Reviewofrequirementsrelatedtotheproduct.........................707.2.3Customercommunication............737.3.1Designanddevelopmentplanning......757.3.2Designaddevelopmentinputs.........777.3.3Designanddevelopmentoutputs.......797.3.4Designanddevelopmentreview........827.3.5Designanddevelopmentverification.....847.3.6Designanddevelopmentvalidation......867.3.7Controlofdesignanddevelopmentchanges...........................89viContents7.4.1Purchasingprocess.................907.4.2Purchasinginformation..............927.4.3Verificationofpurchasedproduct.......947.5.1Controlofproductionandserviceprovision.....................967.5.2Validationofprocessesforproductionandserviceprovision.................1007.5.3Identificationandtraceability...