TS169492002版英文检查表(1)

1QualitySystemAssessmentCheck-ListChecklisttoISO/TS16949:20022Lastrevision09/10/2001SecondEdition,IssuedOctober,2001Copyright©2001©DaimlerChrysler,FordMotorCompany,GeneralMotorsCorp.,©ANFIA,©CCFA/FIEV,©VDA,©SMMT3FOREWORDTheQualitySystemAssessmentCheck-ListtoISO/TS16949SecondEditionisbasedonthecontentofISO/TS16949anditiseffectiveforthelifeofISO/TS16949,SecondEdition.TheQualitySystemAssessmentCheck-LististobeusedasaguideinauditingtherequirementsofISO/TS16949,SecondEdition.TherequirementscolumnreferencestheclausesinISO/TS16949.AllitalicsareISO9001:2000.TheWhattolookforcolumnisnotmandatorybutitisagoodguide.Itisexpectedthatauditorswillsupplementthiscolumnwiththeireducatedandexperiencedenhancements.AcknowledgementsforthiseffortareduetotheIATFmembership.4ELEMENT4–QualitymanagementsystemRequirementsWhattolookforAssessornotes/Objectiveevidence4.1GeneralRequirements4.1.1HastheorganizationestablishedanddocumentedaqualitymanagementsysteminaccordancewiththerequirementsofISO/TS16949:2002(E)?(4.1)QualitymanualaccordingtoTS16949oronewithaconversionmatrix.4.1.2HastheorganizationimplementedandmaintaineditsestablishedqualitymanagementsysteminaccordancewiththerequirementsofISO/TS16949:2002(E)?(4.1)Keypersonnelinterview.Examplesofeffectiveimplementation.4.1.3IstheorganizationcontinuallyimprovingtheeffectivenessofitsqualitymanagementsysteminaccordancewiththerequirementsofISO/TS16949:2002(E)?(4.1.1.1)Examplesandstatusofqualitymanagementsystemcontinuousimprovementprojects,notcorrectiveactions.Managementreviewresults.4.1.4Doestheorganization’squalitymanagementsystem:a)identifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization?b)determinethesequenceandinteractionoftheseprocesses?c)determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective?(4.1.a,b,c)QualitymanualaccordingtoTS16949oronewithaconversionmatrix.54.1.7Doestheorganization’squalitymanagementsystem:a)ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheprocessesneededforitsqualitymanagementsystem?b)monitor,measureandanalyzetheprocessesneededforitsqualitymanagementsystem?c)implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheprocessesneededforitsqualitymanagementsystem?(4.1.d,e,f)Reviewofalltheelementsofthequalitymanagementsystemtoinsureitscontinuingsuitabilityandeffectiveness.ReviewofqualitycostindicatorsManagementreviewmeetingminutes,attendanceandadequatefrequency.Actionplansandfollow-up.4.1.10DoestheorganizationmanagetheprocessesneededforitsqualitymanagementsysteminaccordancewiththerequirementofISO/TS16949:2002(E)?(4.1)4.1.11Doestheorganizationensurecontroloveroutsourcedprocessesthataffectsproductconformitywithrequirements?(4.1)4.1.12Isthecontroloftheorganization’soutsourcedprocessesthataffectsproductconformitywithrequirementsidentifiedwithinthequalitymanagementsystem?(4.1)QualitymanualaccordingtoTS16949oronewithaconversionmatrix.ELEMENT4.2Documentationrequirements4.2.1General64.2.1Doesthequalitymanagementsystemdocumentationincludethefollowing:a)documentedstatementsofaqualitypolicyandqualityobjectives?b)aqualitymanual?c)documentedproceduresrequiredbyISO/TS16949:2002(E)?d)documentsneededbytheorganizationtoensuretheeffectiveplanning,operationandcontrolofitsprocesses?e)recordsrequiredbyISO/TS16949:2002(E)(seeelement4.2.4)?(4.2.1)QualitymanualaccordingtoTS16949oronewithaconversionmatrix.Adequacyoftheprocedurestothecomplexityoftheorganization.Qualitymanagementsystemprocedures.Qualityrecords.4.2.2QualityManual4.2.2Hastheorganizationestablishedandmaintainedaqualitymanualthatincludes:a)thescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions(seesection1.2ofISO/TS16949:2002(E))?b)thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem?c)adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem?(4.2.2)QualitymanualaccordingtoTS16949oronewithaconversionmatrix.4.2.3Controlofdocuments4.2.3Doestheorganizationcontrolthedocumentsrequiredbythequalitymanagementsystem?(4.2.3)QualitymanualaccordingtoTS16949oronewithaconversionmatrix.Documentcontrolmasterlistorequivalent.74.2.3Hastheorganizationestablishedadocumentedproceduretodefinecontrolsneeded:a)toapprovedocumentsforadequacypriortoissue?a)toreviewandupdateasnecessaryandre-approvedocuments?b)toensurethatchangesandthecurrentrevisionstatusofdocumentsareidentified?c)toensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse?d)toensurethatdocumentsremainlegibleandreadilyidentifiable?e)toensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled?f)topreventtheunintendeduseofobsoletedocuments,andtoapplysuitableidentificationtothemiftheyareretainedforanypurpose?(4.2.3)Documentapprovalauthority.Documentapprovalrecords.Availabilityofdocumentsinvariouslocations.Knowledgeofdocumentslocation.Documentaccessibility.Storageanddisposalofobsoletedocuments.Processfornotificati