ISO TS16949 2nd Edition Checklist

1QualitySystemAssessmentCheck-ListChecklisttoISO/TS16949Lastrevision09/10/2001SecondEdition,IssuedOctober,2001Copyright©2001©DaimlerChrysler,FordMotorCompany,GeneralMotorsCorp.,©ANFIA,©2CCFA/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.•4.1.7Doestheorganization’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)•54.1.11Doestheorganizationensurecontroloveroutsourcedprocessesthataffectsproductconformitywithrequirements?(4.1)•4.1.12Isthecontroloftheorganization’soutsourcedprocessesthataffectsproductconformitywithrequirementsidentifiedwithinthequalitymanagementsystem?(4.1)•QualitymanualaccordingtoTS16949oronewithaconversionmatrix.•ELEMENT4.2Documentationrequirements4.2.1General4.2.1Doesthequalitymanagementsystemdocumentationincludethefollowing: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.64.2.3Hastheorganizationestablishedadocumentedproceduretodefinecontrolsneeded: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.•Processfornotification/dis