应用的质量管理系统汽车供应商特殊要求ISO90012021英文.docx

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!'ISO9001:2000ReferencenumberISO/ITS16949:2002(E)©ISO2002Allrightsreserved.Unlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicormechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromthepublisher.InternationalOrganizationforStandardizationCasepostale56CH-1211Geneve20SwitzerlandInternetisoiso.chThecontentinsidetheboxedtextofthisdocumentisISO9001:2000textandisprotectedbytheabovecopyrightstatement.ThetextoutsidetheboxeshasbeenoriginatedbytheInternationalAutomotiveTaskForce.CopyrightforthistextisheldbyANFIA,CCFA/FIEV,SMMT1VDA(seebelow)andthecarmanufacturersDaimlerChryslerA.G.,FordMotorCompany,GeneralMotorsCorp.NeitherthisTechnicalSpecificationnoranyextractfromitmaybereproducedinaretrievalsystemortransmittedinanyformorbyanymeans,electronic,photocopying,recordingorotherwisewithoutpriorwrittenpermissionbeingsecured.Requestsforpermissiontoreproduceand/ortranslatenon-boxedtextshouldbeaddressedtooneoftheaddressesbelow:InternationalAutomotiveOversightBureau(IAOBUSA)AssociazioneNazionaleFraIndustrieAutomobilistiche(ANFIAZItaIy)ComitedesConstructeursFranaisd'Automobiles(CCFA/France)FederationdesIndustriesdesEquipementspourVehicules(FIEVZFrance)SocietyofMotorManufacturersandTraders(SMMT/UK)VerbandderAutomobilindustrie-QualitatsmanagementCenter(VDA-OMC/Germany)ContentsCOntemSiiForewordviRemarksforcertificationviiIntroductionviii0.1Generalviii0.2Processapproachviii0.3RelationshipwithISO9004x0.3.1IATFGuidancetoISO/TS16949:2002×0.4Compatibilitywithothermanagementsystemsx0.5GoalofthisTechnicalSpecificationxQualitymanagementsystems-Automotivesuppliers-ParticularrequirementsfortheapplicationofISO9001:200011 Scope11.1 General11.2 Application12 Normativereference23 Termsanddefinitions23.1 Termsanddefinitionsfortheautomotiveindustry24 Qualitymanagementsystem54.1 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 Qualitypolicy85.4 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 1Customerrepresentative105.5.4 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,awarenessandtraining126.2.2.1 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 Productrealization137.1 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 Reviewofrequirementsrelatedtotheproduct157.2.2.1 Organizationmanufacturingfeasibility167.2.3 Customercommunication167.2.3.1 Customercommunication-Supplemental167.3 Designanddevelopment167.3.1 Designanddevelopmentplanning167.3.1.1 Multidisciplinaryapproach177.3.2 Designanddevelopmentinputs177.3.2.1 Productdesigninput177.3.2.2 Manufacturingprocessdesigninput177.3.2.3 Specialcharacteristics177.33Designanddevelopmentoutputs181.1.1.1 Productdesignoutputs-Supplemental181.1.1.2 Manufacturingprocessdesignoutput187.3.4 Designanddevelopmentreview197.3.4.1 Monitoring197.3.5 Designanddevelopmentverification197.3.6 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 Supplierqualitymanagementsystemdevelopment7.4.1.3 Customer-approvedsources7.4.2 Purchasinginformation7.4.3 Verificationofpurchasedproduct7.4.3.11ncomingproductquality7.4.3.2Supplie