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1、应用的质量管理系统汽车供应商特殊要求IS090012021英文ISO/TC176N660TECHNICALISO/TSSPECIFICATION16949QualitymanagementsystemsAutomotivesuppliersParticularrequirementsfortheapplicationofISO9001:2000SystemesdemanagementdeIaqualiteFournisseursde!automobileExigencesparticulierespour!,applicationde!ISO9001:2000ReferencenumberIS
2、O/ITS16949:2002(E)ISO2002Allrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicormechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromthepublisher.InternationalOrganizationforStandardizationCasepostale56CH-121
3、1Geneve20SwitzerlandInternetisoiso.chThecontentinsidetheboxedtextofthisdocumentisISO9001:2000textandisprotectedbytheabovecopyrightstatement.ThetextoutsidetheboxeshasbeenoriginatedbytheInternationalAutomotiveTaskForce.CopyrightforthistextisheldbyANFIA,CCFA/FIEV,SMMT1VDA(seebelow)andthecarmanufacturer
4、sDaimlerChryslerA.G.,FordMotorCompany,GeneralMotorsCorp.NeitherthisTechnicalSpecificationnoranyextractfromitmaybereproducedinaretrievalsystemortransmittedinanyformorbyanymeans,electronic,photocopying,recordingorotherwisewithoutpriorwrittenpermissionbeingsecured.Requestsforpermissiontoreproduceand/or
5、translatenon-boxedtextshouldbeaddressedtooneoftheaddressesbelow:InternationalAutomotiveOversightBureau(IAOBUSA)AssociazioneNazionaleFraIndustrieAutomobilistiche(ANFIAZItaIy)ComitedesConstructeursFranaisdAutomobiles(CCFA/France)FederationdesIndustriesdesEquipementspourVehicules(FIEVZFrance)SocietyofM
6、otorManufacturersandTraders(SMMT/UK)VerbandderAutomobilindustrie-QualitatsmanagementCenter(VDA-OMC/Germany)ContentsCOntemSiiForewordviRemarksforcertificationviiIntroductionviii0.1Generalviii0.2Processapproachviii0.3RelationshipwithISO9004x0.3.1IATFGuidancetoISO/TS16949:20020.4Compatibilitywithotherm
7、anagementsystemsx0.5GoalofthisTechnicalSpecificationxQualitymanagementsystems-Automotivesuppliers-ParticularrequirementsfortheapplicationofISO9001:200011 Scope11.1 General11.2 Application12 Normativereference23 Termsanddefinitions23.1 Termsanddefinitionsfortheautomotiveindustry24 Qualitymanagementsy
8、stem54.1 Generalrequirements54.2 Documentationrequirements54.2.1 General54.2.2 Oualitvmanual64.2.3 Controlofdocuments64.2.3.1 Engineeringspecifications74.2.4 Controlofrecords74.2.4.1 Recordsretention75 Managementresponsibility75.1 Managementcommitment75.1.1 Processefficiency85.2 Customerfocus85.3 Qu
9、alitypolicy85.4 Planning85.4.1 Oualitvobjectives85.4.1.1 Qualityobjectives-Supplemental85.4.2 Oualitymanagementsystemplanning95.5 Responsibility,authorityandcommunication95.5.1 Responsibilityandauthority95.5.1.1 Responsibilityforquality95.5.2 Managementrepresentative95.5.3 1Customerrepresentative105
10、.5.4 Internalcommunication105.6 Managementreview105.6.1 General105.6.1.1 Qualitymanagementsystemperformance105.6.2 Reviewinput105.6.2.1 Reviewinput-Supplemental115.6.3 Reviewoutput116 Resourcemanagement116.1 Provisionofresources116.2 Humanresources116.2.1 General116.2.2 Competence,awarenessandtraini
11、ng126.2.2.1 Productdesignskills126.2.2.2 Training126.2.2.3 Trainingonthejob126.2.2.4 Employeemotivationandempowerment126.3 Infrastructure126.3.1 Plant,facilityandequipmentplanning136.3.2 Contingencyplans136.4 Workenvironment136.4.1 Personnelsafety136.4.2 Cleanlinessofpremises137 Productrealization13
12、7.1 Planningofproductrealization137.1.1 PlanningOfproductrealization-Supplemental147.1.2 Acceptancecriteria147.1.3 Confidentiality147.1.4 Changecontrol147.2 Customer-relatedprocesses157.2.1 Determinationofrequirementsrelatedtotheproduct157.2.1.1 Customer-designatedspecialcharacteristics157.2.2 Revie
13、wofrequirementsrelatedtotheproduct157.2.2.1 Organizationmanufacturingfeasibility167.2.3 Customercommunication167.2.3.1 Customercommunication-Supplemental167.3 Designanddevelopment167.3.1 Designanddevelopmentplanning167.3.1.1 Multidisciplinaryapproach177.3.2 Designanddevelopmentinputs177.3.2.1 Produc
14、tdesigninput177.3.2.2 Manufacturingprocessdesigninput177.3.2.3 Specialcharacteristics177.33Designanddevelopmentoutputs181.1.1.1 Productdesignoutputs-Supplemental181.1.1.2 Manufacturingprocessdesignoutput187.3.4 Designanddevelopmentreview197.3.4.1 Monitoring197.3.5 Designanddevelopmentverification197
15、.3.6 Designanddevelopmentvalidation197.3.6.1 Designanddevelopmentvalidation-Supplemental7.3.6.2 Prototypeprogramme7.3.6.3 Productapprovalprocess7.3.7 Controlofdesignanddevelopmentchanges7.4Purchasing7.4.1 Purchasingprocess7.4.1.1 Regulatorycompliance7.4.1.2 Supplierqualitymanagementsystemdevelopment
16、7.4.1.3 Customer-approvedsources7.4.2 Purchasinginformation7.4.3 Verificationofpurchasedproduct7.4.3.11ncomingproductquality7.4.3.2Suppliermonitoring7.5 Productionandserviceprovision7.5.1 Controlofproductionandsen/iceprovision7.5.1.1 Controlplan7.5.1.2 Workinstructions7.5.1.3 Verificationofjobset-up
17、s7.5.1.4 PreventiveandPredictivemaintenance7.5.1.5 Managementofproductiontooling7.5.1.6 Productionscheduling7.5.1.7 Feedbackofinformationfromservice7.5.1.8 Servicingagreementwithcustomer7.5.2 Validationofprocessesforproductionandserviceprovision7.5.2.1 ValidationOfprocessesforproductionandservicepro
18、vision-Supplemental7.5.3 Identificationandtraceability7.5.3.11dentificationandtraceability-Supplemental7.5.4 Customerproperty7.5.4.1 Customer-ownedproductiontooling7.5.5 Preservationofproduct7.5.5.1 Storageandinventory7.6 Controlofmonitoringandmeasuringdevices7.6.1 Measurementsystemanalysis7.6.2 Cal
19、ibrationrecords7.6.3 1.aboratoryrequirements7.6.3.1 Internallaboratory7.6.3.2 Externallaboratory8Measurement,analysisandimprovement8.1 General8.1.1 IdentificationOfstatisticaltools8.1.2 Knowledgeofbasicstatisticalconcepts8.2 Monitoringandmeasurement8.2.1 Customersatisfaction8.2.1.1 Customersatisfact
20、ion-Supplemental8.2.2 Internalaudit79勿勿刃勿202/27272/2/222222222223232323242424242424252525252526花2627272727282828282828298.2.2.1 Qualitymanagementsystemaudit8.2.2.2 Manufacturingprocessaudit298.2.2.3 Productaudit298.2.2.4 Internalauditplans298.2.2.5 Internalauditorqualification298.2.3 Monitoringandme
21、asurementofprocesses298.2.3.1 Monitoringandmeasurementofmanufacturingprocesses308.2.4 Monitoringandmeasurementofproduct308.2.4.1 Layoutinspectionandfunctionaltesting318.2.4.2 Appearanceitems318.3 Controlofnonconformingproduct318.3.1 Controlofnonconformingproduct-Supplemental318.3.2 Controlofreworked
22、product318.3.3 Customerinformation328.3.4 Customerwaiver328.4 Analysisofdata328.4.1 Analysisanduseofdata328.5 Improvement328.5.1 Continualimprovement328.5.1.1 Continualimprovementoftheorganization338.5.1.2 Manufacturingprocessimprovement338.5.2 Correctiveaction338.5.2.1 Problemsolving338.5.2.2 Error
23、-proofing338.5.2.3 Correctiveactionimpact338.5.2.4 Rejectedproducttest/analysis348.5.3 Preventiveaction34AnnexA35A.1Phasesofthecontrolplan35A.2Elementsofthecontrolplan35ISO9001:2000headingsarenormaltypeface,IATFheadingsareinitalicsForewordISO(theInternationalOrganizationforStandardization)isaworldwi
24、defederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governm
25、entalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofElectrotechnicalstandardization.InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part3.DraftInternationalStandards
26、adoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting.Inothercircumstances,particularlywhenthereisanurgentmarketrequirementforsuchdocuments,atechnicalcommitteemaydecidetopublishothertypesofnormativedocument:-anISOPubliclyAvailableSpecification(ISO/PAS)representsanagreementbetweentec
27、hnicalexpertsinanISOworkinggroupandisacceptedforpublicationifitisapprovedby50%ofthemembersoftheparentcommitteecastingavote;-anISOTechnicalSpecification(ISOfTS)representsanagreementbetweenthemembersofatechnicalcommitteeandisacceptedforpublicationifitisapprovedby213ofthemembersofthecommitteecastingavo
28、te.AnISO/PASorISO/TSisreviewedeverythreeyearswithaviewtodecidingwhetheritcanbetransformedintoanInternationalStandard.ISO/TS16949:2002waspreparedbytheInternationalAutomotiveTaskForce(IATF)andJapanAutomobileManufacturersAssociationInc.(JAMA),withsupportfromISO/TC176,Qualitymanagementandqualityassuranc
29、e.ThissecondeditionofISO/TS16949cancelsandreplacethefirstedition(ISO/TS16949:1999),whichhasbeentechnicallyrevised.BoxedtextisoriginalISO9001:2000text.Thesector-specificsupplementalrequirementsareoutsidetheboxes.InthisTechnicalSpecification,thewordshallindicatesrequirements.ParagraphsmarkedNOTEarefor
30、guidanceinunderstandingorclarifyingtheassociatedrequirement.ThewordshouldappearinginaNOTEisforguidanceonly.Wherethetermsuchasisused,anysuggestionsgivenareforguidanceonly.RemarksforcertificationThecertificationtothisTechnicalSpecification,includingcustomer-specificrequirementsifany,isrecognizedbythec
31、ustomersmembersofIATFwhenachievedaccordingtotheIATFcertificationscheme(seetheRulesforachievingIATFrecognition).DetailscanbeobtainedattheaddressesofthelocaloversightbodiesofIATFcitedbelow:AssociazioneNazionaleFraIndustrieAutomobilistiche(ANFIA)InternationalAutomotiveOversightBureau(IAOB)Federationdes
32、IndustriesdesEquipementspourVehicules(FIEV)ComitedesConstructeursFrangaisdAutomobiles(CCFA)SocietyofMotorManufacturersandTradersLtd.(SMMTLtd.)VerbandderAutomobilindustrie(VDA)QualitatsmanagementCenter(QMC)Introduction0.1GeneralISO9001:2000,Qualitymanagementsystems-RequirementsIntroduction0.1GeneralT
33、headoptionofaqualitymanagementsystemshouldbeastrategicdecisionofanorganization.Thedesignandimplementationofanorganizationsqualitymanagementsystemisinfluencedbyvaryingneeds,particularobjectives,theproductsprovided,theprocessesemployedandthesizeandstructureoftheorganization.ItisnottheintentofthisInter
34、nationalStandardtoimplyuniformityinthestructureofqualitymanagementsystemsoruniformityofdocumentation.ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandardarecomplementarytorequirementsforproducts.Informationmarked“NOTE”isforguidanceinunderstandingorclarifyingtheassociatedrequire
35、ment.ThisInternationalStandardcanbeusedbyinternalandexternalparties,includingcertificationbodies,toassesstheorganizationsabilitytomeetcustomer,regulatoryandtheorganizationsownrequirements.ThequalitymanagementprinciplesstatedinISO9001andISO9004havebeentakenintoconsiderationduringthedevelopmentofthisI
36、nternationalStandard.0.2ProcessapproachISO9001:2000,Qualitymanagementsystems-Requirements0.2ProcessapproachThisInternationalStandardpromotestheadoptionofaprocessapproachwhendeveloping,implementingandimprovingtheeffectivenessofaqualitymanagementsystem,toenhancecustomersatisfactionbymeetingcustomerreq
37、uirements.Foranorganizationtofunctioneffectively,ithastoidentifyandmanagenumerouslinkedactivities.Anactivityusingresources,andmanagedinordertoenablethetransformationofinputsintooutputs,canbeconsideredasaprocess.Oftentheoutputfromoneprocessdirectlyformstheinputtothenext.Theapplicationofasystemofproce
38、sseswithinanorganization,togetherwiththeidentificationandinteractionsoftheseprocesses,andtheirmanagement,canbereferredtoastheprocessapproach,.Anadvantageoftheprocessapproachistheongoingcontrolthatitprovidesoverthelinkagebetweentheindividualprocesseswithinthesystemofprocesses,aswellasovertheircombina
39、tionandinteraction.Whenusedwithinaqualitymanagementsystem,suchanapproachemphasizestheimportanceofa) understandingandfulfillingrequirements,b) theneedtoconsiderprocessesintermsofaddedvalue,c) obtainingresultsofprocessperformanceandeffectiveness,andd)continualimprovementofprocessesbasedonobjectivemeas
40、urement.Themodelofaprocess-basedqalftymanagementsystemshowninFigure1illustratestheprocesslinkagespresentedinclauses4to8.Thisillustrationshowsthatcustomersplayasignificantroleindefiningrequirementsasinputs.Monitoringofcustomersatisfactionrequirestheevaluationofinformationrelatingtocustomerperceptiona
41、stowhethertheorganizationhasmetthecustomerrequirements.ThemodelshowninFigure1coversalltherequirementsofthisInternationalStandard,butdoesnotshowprocessesatadetailedlevel.NOTEInaddition,themethodologyknownasPlan-Do-Check-Act(PDCA)canbeappliedtoallprocesses.PDCAcanbebrieflydescribedasfollows.Plan:estab
42、lishtheobjectivesandprocessesnecessarytodeliverresultsinaccordancewithcustomerrequirementsandtheorganizationspolicies.Do:implementtheprocesses.Check:monitorandmeasureprocessesandproductagainstpolicies,objectivesandrequirementsfortheproductandreporttheresults.Act:takeactionstocontinuallyimproveproces
43、sperformance.Value-addingactivitiesInformationflowFigure1-Modelofaprocess-basedqualitymanagementsystem0.3RelationshipwithISO9004ISO9001:2000,Qualitymanagementsystems-Requirements0.3RelationshipwithISO9004ThepresenteditionsofISO9001andISO9004havebeendevelopedasaconsistentpairofqualitymanagementsystem
44、standardswhichhavebeendesignedtocomplementeachother,butcanalsobeusedindependently.AlthoughthetwoInternationalStandardshavedifferentscopes,theyhavesimilarstructuresinordertoassisttheirapplicationasaconsistentpair.ISO9001specifiesrequirementsforaqualitymanagementsystemthatcanbeusedforinternalapplicati
45、onbyorganizations,orforcertification,orforcontractualpurposes.Itfocusesontheeffectivenessofthequalitymanagementsysteminmeetingcustomerrequirements.ISO9004givesguidanceonawiderrangeofobjectivesofaqualitymanagementsystemthandoesISO9001,particularlyforthecontinualimprovementofanorganizationsoverallperf
46、ormanceandefficiency,aswellasitseffectiveness.ISO9004isrecommendedasaguidefororganizationswhosetopmanagementwishestomovebeyondtherequirementsofISO9001,inpursuitofcontinualimprovementofperformance.However,itisnotintendedforcertificationorforcontractualpurposes.NOTETheknowledgeanduseoftheeightqualitym
47、anagementprinciplesreferredtointheISO9000:2000andISO9004:2000canbedemonstratedandcascadedthroughtheorganizationbytopmanagement.0.3.1IATFGuidancetoISO/TS16949:2002IATFGuidancetoISO/TS16949:2002containsrecommendedautomotiveindustrypractices,examples,illustrationsandexplanationsthat,ifusedmayprovideassistanceintheapplicationtoconformtotherequirementsofthisTechnicalSpecification.Itisnotintendedforcertificationorforcontractualpurposes0.4CompatibilitywithothermanagementsystemsISO9001:2000,Qualitymanagementsystems-Requirements0.
