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首页 ISOTS16949 2009英文正式版

ISOTS16949 2009英文正式版.pdf

ISOTS16949 2009英文正式版

shangwenpu
2010-07-14 0人阅读 举报 0 0 暂无简介

简介:本文档为《ISOTS16949 2009英文正式版pdf》,可适用于企业制度领域

TECHNICALSPECIFICATIONISOTSThirdeditionQualitymanagementsystemsParticularrequirementsfortheapplicationofISO:forautomotiveproductionandrelevantservicepartorganizationsReferencenumberISOTS:(E)©ISOIntroductionGeneralISO:,QualitymanagementsystemsRequirementsIntroductionGeneralTheadoptionofaqualitymanagementsystemshouldbeastrategicdecisionofanorganizationThedesignandimplementationofanorganization'squalitymanagementsystemisinfluencedbya)itsorganizationalenvironment,changesinthatenvironment,andtherisksassociatedwiththatenvironment,b)itsvaryingneeds,c)itsparticularobjectives,d)theproductsitprovides,e)theprocessesitemploys,f)itssizeandorganizationalstructureItisnottheintentofthisInternationalStandardtoimplyuniformityinthestructureofqualitymanagementsystemsoruniformityofdocumentationThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandardarecomplementarytorequirementsforproductsInformationmarked“NOTE”isforguidanceinunderstandingorclarifyingtheassociatedrequirementThisInternationalStandardcanbeusedbyinternalandexternalparties,includingcertificationbodies,toassesstheorganization'sabilitytomeetcustomer,statutoryandregulatoryrequirementsapplicabletotheproduct,andtheorganization'sownrequirementsThequalitymanagementprinciplesstatedinISOandISOhavebeentakenintoconsiderationduringthedevelopmentofthisInternationalStandardProcessapproachISO:,QualitymanagementsystemsRequirementsProcessapproachThisInternationalStandardpromotestheadoptionofaprocessapproachwhendeveloping,implementingandimprovingtheeffectivenessofaqualitymanagementsystem,toenhancecustomersatisfactionbymeetingcustomerrequirementsForanorganizationtofunctioneffectively,ithastodetermineandmanagenumerouslinkedactivitiesAnactivityorsetofactivitiesusingresources,andmanagedinordertoenablethetransformationofinputsintooutputs,canbeconsideredasaprocessOftentheoutputfromoneprocessdirectlyformstheinputtothenextTheapplicationofasystemofprocesseswithinanorganization,togetherwiththeidentificationandinteractionsoftheseprocesses,andtheirmanagementtoproducethedesiredoutcome,canbereferredtoasthe“processapproach”Anadvantageoftheprocessapproachistheongoingcontrolthatitprovidesoverthelinkagebetweentheindividualprocesseswithinthesystemofprocesses,aswellasovertheircombinationandinteractionWhenusedwithinaqualitymanagementsystem,suchanapproachemphasizestheimportanceofa)understandingandmeetingrequirements,b)theneedtoconsiderprocessesintermsofaddedvalue,c)obtainingresultsofprocessperformanceandeffectiveness,andd)continualimprovementofprocessesbasedonobjectivemeasurementThemodelofaprocessbasedqualitymanagementsystemshowninFigureillustratestheprocesslinkagespresentedinClausestoThisillustrationshowsthatcustomersplayasignificantroleindefiningrequirementsasinputsMonitoringofcustomersatisfactionrequirestheevaluationofinformationrelatingtocustomerperceptionastowhethertheorganizationhasmetthecustomerrequirementsThemodelshowninFigurecoversalltherequirementsofthisInternationalStandard,butdoesnotshowprocessesatadetailedlevelNOTEInaddition,themethodologyknownas“PlanDoCheckAct”(PDCA)canbeappliedtoallprocessesPDCAcanbebrieflydescribedasfollowsPlan:establishtheobjectivesandprocessesnecessarytodeliverresultsinaccordancewithcustomerrequirementsandtheorganization'spoliciesDo:implementtheprocessesCheck:monitorandmeasureprocessesandproductagainstpolicies,objectivesandrequirementsfortheproductandreporttheresultsAct:takeactionstocontinuallyimproveprocessperformanceFigureModelofaprocessbasedqualitymanagementsystemRelationshipwithISOISO:,QualitymanagementsystemsRequirementsRelationshipwithISOISOandISOarequalitymanagementsystemstandardswhichhavebeendesignedtocomplementeachother,butcanalsobeusedindependentlyISOspecifiesrequirementsforaqualitymanagementsystemthatcanbeusedforinternalapplicationbyorganizations,orforcertification,orforcontractualpurposesItfocusesontheeffectivenessofthequalitymanagementsysteminmeetingcustomerrequirementsAtthetimeofpublicationofthisInternationalStandard,ISOisunderrevisionTherevisededitionofISOwillprovideguidancetomanagementforachievingsustainedsuccessforanyorganizationinacomplex,demanding,andeverchanging,environmentISOprovidesawiderfocusonqualitymanagementthanISOitaddressestheneedsandexpectationsofallinterestedpartiesandtheirsatisfaction,bythesystematicandcontinualimprovementoftheorganization’sperformanceHowever,itisnotintendedforcertification,regulatoryorcontractualuseNOTETheknowledgeanduseoftheeightqualitymanagementprinciplesreferredtoinISO:andISO:shouldbedemonstratedandcascadedthroughtheorganizationbytopmanagementCompatibilitywithothermanagementsystemsISO:,QualitymanagementsystemsRequirementsCompatibilitywithothermanagementsystemsDuringthedevelopmentofthisInternationalStandard,dueconsiderationwasgiventotheprovisionsofISO:toenhancethecompatibilityofthetwostandardsforthebenefitoftheusercommunityAnnexAshowsthecorrespondencebetweenISO:andISO:ThisInternationalStandarddoesnotincluderequirementsspecifictoothermanagementsystems,suchasthoseparticulartoenvironmentalmanagement,occupationalhealthandsafetymanagement,financialmanagementorriskmanagementHowever,thisInternationalStandardenablesanorganizationtoalignorintegrateitsownqualitymanagementsystemwithrelatedmanagementsystemrequirementsItispossibleforanorganizationtoadaptitsexistingmanagementsystem(s)inordertoestablishaqualitymanagementsystemthatcomplieswiththerequirementsofthisInternationalStandardGoalofthisTechnicalSpecificationThegoalofthisTechnicalSpecificationisthedevelopmentofaqualitymanagementsystemthatprovidesforcontinualimprovement,emphasizingdefectpreventionandthereductionofvariationandwasteinthesupplychainThisTechnicalSpecification,coupledwithapplicablecustomerspecificrequirements,definesthefundamentalqualitymanagementsystemrequirementsforthosesubscribingtothisTechnicalSpecificationThisTechnicalSpecificationisintendedtoavoidmultiplecertificationauditsandprovideacommonapproachtoaqualitymanagementsystemforautomotiveproduction,andrelevantservicepartorganizationsRTECHNICALSPECIFICATIONISOTS:(E)QualitymanagementsystemsParticularrequirementsfortheapplicationofISO:forautomotiveproductionandrelevantservicepartorganizationsScopeGeneralISO:,QualitymanagementsystemsRequirementsScopeGeneralThisInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationa)needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicablestatutoryandregulatoryrequirements,andb)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicablestatutoryandregulatoryrequirementsNOTEInthisInternationalStandard,theterm“product”onlyappliestoa)productintendedfor,orrequiredby,acustomer,b)anyintendedoutputresultingfromtheproductrealizationprocessesNOTEStatutoryandregulatoryrequirementscanbeexpressedaslegalrequirementsThisTechnicalSpecification,inconjunctionwithISO:,definesthequalitymanagementsystemrequirementsforthedesignanddevelopment,productionand,whenrelevant,installationandserviceofautomotiverelatedproductsThisTechnicalSpecificationisapplicabletositesoftheorganizationwherecustomerspecifiedparts,forproductionandorservice,aremanufacturedSupportingfunctions,whetheronsiteorremote(suchasdesigncentres,corporateheadquartersanddistributioncentres),formpartofthesiteauditastheysupportthesite,butcannotobtainstandalonecertificationtothisTechnicalSpecificationThisTechnicalSpecificationcanbeappliedthroughouttheautomotivesupplychainApplicationISO:,QualitymanagementsystemsRequirementsApplicationAllrequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoallorganizations,regardlessoftype,sizeandproductprovidedISOTS:(E)Whereanyrequirement(s)ofthisInternationalStandardcannotbeappliedduetothenatureofanorganizationanditsproduct,thiscanbeconsideredforexclusionWhereexclusionsaremade,claimsofconformitytothisInternationalStandardarenotacceptableunlesstheseexclusionsarelimitedtorequirementswithinClause,andsuchexclusionsdonotaffecttheorganization'sability,orresponsibility,toprovideproductthatmeetscustomerandapplicablestatutoryandregulatoryrequirementsTheonlypermittedexclusionsforthisTechnicalSpecificationrelatetowheretheorganizationisnotresponsibleforproductdesignanddevelopmentPermittedexclusionsdonotincludemanufacturingprocessdesignNormativereferencesThefollowingreferenceddocumentsareindispensablefortheapplicationofthisdocumentFordatedreferences,onlytheeditioncitedappliesForundatedreferences,thelatesteditionofthereferenceddocument(includinganyamendments)appliesISO:,QualitymanagementsystemsFundamentalsandvocabularyTermsanddefinitionsISO:,QualitymanagementsystemsRequirementsTermsanddefinitionsForthepurposesofthisdocument,thetermsanddefinitionsgiveninISOapplyThroughoutthetextofthisInternationalStandard,wherevertheterm“product”occurs,itcanalsomean“service”TermsanddefinitionsfortheautomotiveindustryForthepurposesofthisdocument,thetermsanddefinitionsgiveninISO:andthefollowingapplycontrolplandocumenteddescriptionofthesystemsandprocessesrequiredforcontrollingproductNOTESeeAnnexAdesignresponsibleorganizationorganizationwithauthoritytoestablishanew,orchangeanexisting,productspecificationNOTEThisresponsibilityincludestestingandverificationofdesignperformancewithinthecustomer'sspecifiedapplicationerrorproofingproductandmanufacturingprocessdesignanddevelopmenttopreventmanufactureofnonconformingproductslaboratoryfacilityforinspection,testorcalibrationthatmayinclude,butisnotlimitedto,chemical,metallurgical,dimensional,physical,electricalorreliabilitytestingISOTS:(E)laboratoryscopecontrolleddocumentcontaining„specifictests,evaluationsandcalibrationsthatalaboratoryisqualifiedtoperform,„alistoftheequipmentwhichitusestoperformtheabove,and„alistofmethodsandstandardstowhichitperformstheabovemanufacturingprocessofmakingorfabricating„productionmaterials,„productionorserviceparts,„assemblies,or„heattreating,welding,painting,platingorotherfinishingservicespredictivemaintenanceactivitiesbasedonprocessdataaimedattheavoidanceofmaintenanceproblemsbypredictionoflikelyfailuremodespreventivemaintenanceplannedactiontoeliminatecausesofequipmentfailureandunscheduledinterruptionstoproduction,asanoutputofthemanufacturingprocessdesignpremiumfreightextracostsorchargesincurredadditionaltocontracteddeliveryNOTEThiscanbecausedbymethod,quantity,unscheduledorlatedeliveries,etcremotelocationlocationthatsupportssitesandatwhichnonproductionprocessesoccursitelocationatwhichvalueaddedmanufacturingprocessesoccurspecialcharacteristicproductcharacteristicormanufacturingprocessparameterwhichcanaffectsafetyorcompliancewithregulations,fit,function,performanceorsubsequentprocessingofproductISOTS:(E)QualitymanagementsystemGeneralrequirementsISO:,QualitymanagementsystemsRequirementsQualitymanagementsystemGeneralrequirementsTheorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandardTheorganizationshalla)determinetheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization(see),b)determinethesequenceandinteractionoftheseprocesses,c)determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective,d)ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses,e)monitor,measurewhereapplicable,andanalysetheseprocesses,andf)implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocessesTheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisInternationalStandardWhereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitytorequirements,theorganizationshallensurecontroloversuchprocessesThetypeandextentofcontroltobeappliedtotheseoutsourcedprocessesshallbedefinedwithinthequalitymanagementsystemNOTEProcessesneededforthequalitymanagementsystemreferredtoaboveshouldincludeprocessesformanagementactivities,provisionofresources,productrealization,measurement,analysisandimprovementNOTEAn“outsourcedprocess”isaprocessthattheorganizationneedsforitsqualitymanagementsystemandwhichtheorganizationchoosestohaveperformedbyanexternalpartyNOTEEnsuringcontroloveroutsourcedprocessesdoesnotabsolvetheorganizationoftheresponsibilityofconformitytoallcustomer,statutoryandregulatoryrequirementsThetypeandextentofcontroltobeappliedtotheoutsourcedprocesscanbeinfluencedbyfactorssuchasa)thepotentialimpactoftheoutsourcedprocessontheorganization'scapabilitytoprovideproductthatconformstorequirements,b)thedegreetowhichthecontrolfortheprocessisshared,c)thecapabilityofachievingthenecessarycontrolthroughtheapplicationofGeneralrequirementsSupplementalEnsuringcontroloveroutsourcedprocessesshallnotabsolvetheorganizationoftheresponsibilityofconformitytoallcustomerrequirementsNOTESeealsoandISOTS:(E)DocumentationrequirementsGeneralISO:,QualitymanagementsystemsRequirementsDocumentationrequirementsGeneralThequalitymanagementsystemdocumentationshallincludea)documentedstatementsofaqualitypolicyandqualityobjectives,b)aqualitymanual,c)documentedproceduresandrecordsrequiredbythisInternationalStandard,andd)documents,includingrecords,determinedbytheorganizationtobenecessarytoensuretheeffectiveplanning,operationandcontrolofitsprocessesNOTEWheretheterm“documentedprocedure”appearswithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintainedAsingledocumentmayaddresstherequirementsforoneormoreproceduresArequirementforadocumentedproceduremaybecoveredbymorethanonedocumentNOTETheextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherduetoa)thesizeoforganizationandtypeofactivities,b)thecomplexityofprocessesandtheirinteractions,andc)thecompetenceofpersonnelNOTEThedocumentationcanbeinanyformortypeofmediumQualitymanualISO:,QualitymanagementsystemsRequirementsQualitymanualTheorganizationshallestablishandmaintainaqualitymanualthatincludesa)thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions(see),b)thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem,andc)adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystemISOTS:(E)ControlofdocumentsISO:,QualitymanagementsystemsRequirementsControlofdocumentsDocumentsrequiredbythequalitymanagementsystemshallbecontrolledRecordsareaspecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgiveninAdocumentedprocedureshallbeestablishedtodefinethecontrolsneededa)toapprovedocumentsforadequacypriortoissue,b)toreviewandupdateasnecessaryandreapprovedocuments,c)toensurethatchangesandthecurrentrevisionstatusofdocumentsareidentified,d)toensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse,e)toensurethatdocumentsremainlegibleandreadilyidentifiable,f)toensurethatdocumentsofexternalorigindeterminedbytheorganizationtobenecessaryfortheplanningandoperationofthequalitymanagementsystemareidentifiedandtheirdistributioncontrolled,andg)topreventtheunintendeduseofobsoletedocuments,andtoapplysuitableidentificationtothemiftheyareretainedforanypurposeEngineeringspecific

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