ISO TS 16949 Update

1ISO/TS16949UpdateAGENDAISO/TS16949UpdateISO9001:2000UpdateISO14001UpdateEnhancedSurveillanceAuditsHighlightsofIASGSanctionedQS-9000:98Interpretations(Nov.1,1999)AQSRReviewRegistrationProcessQuestion&Answer2ISO/TS16949QualitySystems3ISO/TS16949Whatisit?ISO/TS16949isanISOTechnicalSpecificationpreparedbytheInternationalAutomotiveTaskForce(IATF)andrepresentativesfromISO/TC176,QualityManagementandQualityAssurance,anditssubcommittees.ParticularrequirementsfortheapplicationofISO9001:1994areincorporatedintoISO/TS16949.ISO/TS16949harmonizesthesupplierqualitysystemrequirementsoftheUnitedStates,Germany,Italy,France,withthepurposeofhavingasingledocumentandregistrationschemethattheEuropeanandU.S.automotiveindustrywouldaccept.4ISO/TS16949FIATIVECOPSA(PeugotCitoen)RENAULTFIEVAVSQEAQFADAMOPELAUDIBMWDAIMLERBENZFORDWERKEVWCHRYSLERFORDGMVDA6.1QS-9000TechnicalSpecificationISO/TS16949QualitySystems-AutomotiveSuppliers-ParticularrequirementsfortheapplicationofISO9001:19945ISO/TS16949ThisdocumentfollowsthesamestructureasISO9001:1994,withsomeadditionalrequirementsdrawnfromthefollowingdocuments:QS-9000QualitySystemRequirements,ThirdEditionVDA6,Part1:QualitySystemAuditAVSQ’94Guidaperl’applicazione(guidelinesforuse)EvaluationAptitudeQualitéFournisseur(EAQF94)6ISO/TS16949TheelementsoftheISO/TSarecloselyalignedwiththeelementsofthefourautomotivestandards.MostoftheelementsoftheISO/TScanbetracedtoaminimumofoneofthefourautomotivestandards-manyelementscanbetracedtoallfourstandards.7ISO/TS16949ThegoalofthisTechnicalSpecificationisthedevelopmentoffundamentalqualitysystemsthatprovideforcontinuousimprovement,emphasizingdefectpreventionandthereductionofvariationandwasteinthesupplychain.8ISO/TS16949Whythenewstandard?CreateaGlobalQualitySystemLanguageCreateGlobalRecognitionofCertificatesReductioninmultiple3rdpartyregistrationsProvideacompetitiveadvantageAdvantagesforupgradingQM-SystemAdvantagesforglobalsourcing9ISO/TS16949What'sdifferent?Numbering(4.1-4.20)remainsthesameAdditional5%requirementsoveratypicaltier1QS-9000systemRegistrationrequirementsaremuch“tighter”thanQS-900010ISO/TS1694911ISO/TS16949ISOvs.QS-9000:98vs.ISO/TS1694912ISO/TS16949ISOvs.QS-9000:98vs.ISO/TS1694913ISO/TS169494.1.1.2ObjectivesThesuppliershalldefinegoals,objectivesandmeasurementstodeploythequalitypolicy.Objectivesforachievingqualityshallbeincludedinthebusinessplan.NOTEThegoalsandobjectivesshouldaddresscustomerexpectationsandbeachievablewithinadefinedtimeperiod.*moreexplicitaboutqualitypolicyobjectives14ISO/TS169494.1.1.4ContinuousImprovementContinuousimprovementinquality,service,costandtechnologyshallbeprovidedforintheQualityPolicy.Thesuppliershallidentifyopportunitiesforqualityandproductivityimprovementandimplementappropriateimprovementprojects.Thesuppliershalluseappropriateimprovementmeasuresandmethodologies(see4.2.7).15ISO/TS169494.1.1.4ContinousImprovementcont’dNOTE1Thefollowinglistshowsexamplesofpossibletechniqueswhichmightbeused.Theremaybemanyothermethodswhichmeetspecificsupplierneedsmoreappropriately:-controlcharts(variables,attributes,CUSUM),-designofexperiments(DOE),-theoryofconstraints,-overallequipmenteffectiveness,-partspermillion(PPM)analysistoachievezerodefects,16ISO/TS169494.1.1.4ContinuousImprovementcont’d-valueanalysis,-benchmarking,-analysisofmotion/ergonomics,-mistake-proofing.NOTE2GuidelinesforqualityimprovementaregiveninISO9004-4*relocatedfrom4.2.5;moreexplicitaboutqualitypolicyobjectives17ISO/TS169494.1.2.1.3QualityresponsibilityManagementwithresponsibilityandauthorityforcorrectiveactionshallbepromptlyinformedofproductsorprocesseswhichbecomesnon-compliantwithspecifiedrequirements.Personnelresponsibleforqualityshallhavetheauthoritytostopproductiontocorrectqualityproblems.*notechangedintoarequirement18ISO/TS169494.1.2.2.2ShiftresourcesEspeciallyconcerningtheproductionprocess,alltheshiftsshallbestaffedwithpersonnelinchargeof,ordelegatedresponsibilityforquality.*newrequirement19ISO/TS169494.1.3.2Managementreview-supplementalThesereviewsshallincludeallelementsofthequalitysystemanditsperformance(see4.2.8)overtimeasanessentialpartofthecontinuousimprovementprocess.Partofthemanagementreviewshallbethemonitoringofstrategicqualityobjectives,andtheregularreportingandevaluationofthecostofpoorquality.NOTEManagementreviewshouldbeconductedwithsufficientfrequencytoensurethattheestablishedqualitysystemiseffective.*moreexplicitaboutwhattoreview20ISO/TS169494.1.5AnalysisanduseofcompanyleveldataThesuppliershalldocumenttrendsinquality,operationalperformance(productivity,costsofpoorquality,efficiency,effectiveness)andcurrentqualitylevelsforkeyproductandservicefeatures.NOTETheseshouldbecomparedwiththoseofcompetitorsand/orappropriatebenchmarks.21ISO/TS169494.1.5Analysisanduseofcompanyleveldatacont’dTrendsindataandinformationshallbecomparedwithprogresstowardoverallbusinessobjectivesandleadtoactiontosupportthefollowing:a)developmentofprioritiesforpromptsolutionstocustomer-relatedproblems;b)determinationofkeycustomerrelatedtrendsandcorrelationtosupportstatusreview,decisionmakingandlongertermplanning;22ISO/TS169494.1.5Analysisanduseofcompanyleveldatacont’dc)aninformationsystemforthetimelyreportingofproductinformationarisingfromusage.*item“c”isnew23ISO/TS169494.1.6Employeemotivation,empowermentandsatisfactionThesuppliershallhaveaprocessformotivationofemployeestoachievequalityobjectivesandtomakecontinuousimprovements.Theprocessshallincludepromotionofqualityawarenessonalllevels.NOTEQualityreviewsshouldbeconductedtoprovideappropriateinformation,suchas“plan/actual”comparisonandimprovementsuggestions.24ISO/TS169494.1.6Employeemotivation,empowermentandsatisfactioncont’dThesuppliershallhaveaprocessformeasurementofemployeesatisfactionandemployeeunderstandingofappropriatequalityobjectives.*newsub-element25ISO/TS169494.1.7.1Productsafety-Duecareregardingproductsafetyandmeanstominimizepotentialriskstoemployees,customers,usersandtheenvironmentshallbeaddressedinthesupplier’squalitypolicyandpractices,especiallyindesigncontrol(see4.4)andprocesscontrol(see4.9)proceduresandpractices.Thesuppliershallpromoteinternalawarenessofsafetyconsiderationsrelativetothesupplier’sproduct.*QS-9000:98;4.2.3.4moreexplicit26ISO/TS169494.1.7.2Regulations-Thesuppliershallhaveaprocesstoensurecompliancewithallapplicablegovernment,safetyandenvironmentalregulations,includingthoseconcerningstorage,handling,recycling,eliminatingordisposingofmaterials.*QS-9000:98;4.6.1.2moreexplicit27ISO/TS16949ProductrealizationInthisTechnicalSpecification,qualityplanningactivitiesofallpre-launchphaseshavebeenintegratedunderthenewheading“Productrealization”.Forsupplierswithproductdesignresponsibility,productrealizationalsoincludesproductdesign(see4.4).Productrealizationinthecontextofqualityplanningisdiscussedin4.2.4.Thestructureisoutlinedonthenextslide:28ISO/TS16949ProductRealizationcont’d4.2.3Qualityplanning4.2.3.1Qualityplanning-ISO9001:19944.2.3.2Qualityplanrequirements4.2.4Productrealization4.2.4.1General4.2.4.2Measurements4.2.4.3Reviewcycle4.2.4.4Multidisciplinaryapproach4.2.4.5Toolsandtechniques4.2.4.6Computer-aideddesign29ISO/TS16949Productrealizationcont’d4.2.4.7Specialcharacteristics4.2.4.8Feasibilityreview4.2.4Productrealizationcontinued4.2.4.9Managementofprocessdesign4.2.4.9.1General4.2.4.9.2Processdesigninput4.2.4.9.3Processdesignoutput4.2.4.9.4Processverification4.2.4.10Controlplan4.2.4.11Productapprovalprocess*Renumberedandsomenewrequirements30ISO/TS169494.2.8QualitysystemperformanceThesuppliershallevaluatetheperformanceofthequalitysystemtoverifytheeffectivenessofitsoperation.Resultsshallberecordedtoprovide,asaminimum,evidenceoftheachievementof:a)objectivesspecifiedinthequalitypolicy(see4.1.1.2),b)objectivesspecifiedinthebusinessplan(see4.1.4),c)customersatisfactionwithproductsupplied.Theresultsshallbeusedforcontinuousimprovementorcorrectiveactionasappropriate.*moreexplicit31ISO/TS169494.10.6LaboratoryrequirementsWhereinspection,testingandcalibrationservicesareconductedbyasupplier’slaboratoryfacilityshallcomplywithISO/IEC17025,includinguseofalaboratoryscope.NOTEAccreditationofsupplierfacilitiestoISO/IEC17025ornationalequivalentisnotrequiredby,nordoesitsatisfy,allqualitysystemrequirementsspecifiedinthisTechnicalSpecificationforalaboratory.Therefore,thelaboratoryshouldbeincludedintheon-siteaudits.32ISO/TS169494.10.6Laboratoryrequirementscont’dCommercial/independentlaboratoryfacilitiesusedforinspection,testorcalibrationservicesbythesuppliershallbeaccreditedtoISO/IEC17025ornationalequivalent.*newrequirementwithrespecttoISO/IEC1702533ISO/TS169494.17.2.3ProcessauditThesuppliershallaudittheproductrealizationandproductionprocessestodeterminetheeffectivenessofprocessperformance(seeA.43)*newrequirement34ISO/TS16949A.43processauditonsiteverificationactivityusedto:-verifyconformancetospecifiedrequirements,suchascontrolplan,workinstructions,-ensurethatqualityobjectivesaremet,-verifythatspecifiedrequirementsforprocesscapability/performancearemet,-assesstheeffectivenessofactivitiesandrelatedresults35ISO/TS169494.17.3AuditorqualificationThesuppliershallcomplywithcustomerrequirementsforinternalsystemandprocessauditorqualification.*newrequirement36ISO/TS16949AuditProcessThescopeofcertificationshallincludeallproductssuppliedtocustomerssubscribingtothecertificationtoISO/TS1649.Any“site”mayelecttopursuethirdpartycertificationtoISO/TS16949,however,such“sites”shallhavedemonstratedcapabilitytoconformwithallISO/TS16949requirements,includingcustomerspecific.RemotelocationsshallbeauditedastheysupportasitebutcannotobtainindependentISO/TS16949certification.37ISO/TS16949AuditProcesscont’dCertificationbodychecklistsshallincludeallquestionscontainedinthe“ChecklisttoISO/TS16949.”QualitysystemsshallnotberegisteredtoISO/TS16949ifopenminorormajornonconformitiestoISO/TS16949exist.Aftercertification,whenanonconformityisidentifiedbythecertificationbody,thenthedecertificationprocessshallbeinitiated.NOTE:Suchidentificationcanoccurasaresultofacustomercomplaint.38ISO/TS16949Auditprocesscont’dTheauditplanshallincludeevaluationofallsupplierqualitysystemelementsforeffectiveimplementationofISO/TS16949requirementsaswellasforeffectivenessinpractice.Assessmentshallevaluatetheeffectivenessofthesystem,itslinkages,itsperformanceanditsrequirements.Partoftheevidencerequiredistheresultofatleastonecompleteinternalauditandmanagementreviewcycle.NOTE:Effectivenessofthesystemshouldconsiderhowwellthesystemisdeployed.39ISO/TS16949Auditprocesscont’dEachon-siteaudit,includinginitialandsurveillanceaudits,shallincludeareviewof:customercomplaintsandsupplierresponse,supplierinternalauditandmanagementreviewresultsandactions,progressmadetowardcontinuousimprovementtargets,effectivenessofthecorrectiveactionsandverificationsincethelastsurveillanceaudit.Elements4.1,4.2,and4.4fordesignresponsiblesuppliershallbereviewedatleastonceduringanon-siteauditwithineachconsecutive12-monthperiod.40ISO/TS16949AuditActivitiesContractbetweencertificationbodyandsupplierAnalysereadinessforon-siteauditReadinessforon-siteaudit(Incaseofdoubts,thecertificationbodyandthesuppliermaydecidetoexecuteapre-audit).Inthisphase,thecertificationbodycanperforma“pre-audit”atthesupplier’ssites.Documentreview41ISO/TS16949AuditActivitiescont’dPre-auditThepre-auditshallnotbeconsideredaspartoftheinitialcertificationaudit.Timededicatedtothepre-auditwillnotreduceauditdaysrequirement(seeAnnex3)Ifthereisinsufficientreadinesstoconducttheinitialaudit,theSuppliercanstoptheprocess,inconsultationwiththecertificationbody.42ISO/TS16949AuditActivitiescont’dThecertificationbodyshallrecordthisfactinitsdatabase.Theinitialauditshallbecompletedwithina3monthperiodfromthedocumentreview.Multiplevisitsforinitialauditarenotpermitted.Teamof2auditorsminimumifauditor-daysrequirementsexceed4.43ISO/TS16949AuditMandaysforcertificationtoISO/TS1694944ISO/TS16949AuditActivitiesRequirementsonauditmandaysInitialAudit(On-siteMandays)cannotincludepre-auditand/ordocumentreview.On-sitereviewofcorrectiveactionsarisingfromtheinitialauditwillbeadditionaltothespecifiedauditmandays.TheonlydeviationspermittedfromthischartisanupgradefromthecurrentthirdpartycertificationstoAVSQ,EAQF,QS-9000orVDA6.1.45ISO/TS16949AuditActivitiescont’dEachauditshallincludeauditingonallshifts.Ifweekendcrewsarededicatedandnon-rotating,thenauditingoftheweekendshiftsisalsorequired.Nondesigncapablesuppliersmayreduceon-siteauditmandaysby15%.Thecertificationbodyshallpreparemonthlyauditschedule(toforwardtoA/BandIATFcommondatabase).Siteaudit+reports46ISO/TS16949AuditActivitiescont’dInitialcertificationauditactivitiesshallbeconductedaccordingtothefollowingrules:Useofthe“ChecklisttoISO/TS16949”Checklisttobecoveredineachsiteincludedincertificationscope(nositesamplingallowed)RevieweffectivenessoftheimplementationoftheISO/TS16949requirementsandforeffectivenessinpractice,relatedtoplannedandachievedqualityperformance.47ISO/TS16949AuditActivitiescont’dMajornonconformitiesmayprovideabasisforterminationoftheauditbythesupplierinconsultationwiththeauditteamleader.Inthiscaseauditteamleaderwillstopthecertificationprocessimmediately:areportwillbepreparedforthecertificationbody(copyfortheSupplier)ThecertificationbodywillrecordthereasonsforterminationintheirdatabaseandreporttoIATF.Whenthisoccurs,anyre-auditshallcommencefromthebeginningoftheprocess.48ISO/TS16949AuditActivitiescont’dAttheendofthesitevisit,theLeadauditorconductsthefinalpresentationandreleasesadraftreportincluding:descriptionofallnonconformitiesopportunitiesforimprovementauditteamrecommendationstocertificationcommitteeUndernocircumstancescananonconformitybeidentifiedasanopportunityforimprovement.49ISO/TS16949AuditActivitiescont’dAuditteamleaderwithin15workingdaysaftertheendofthesitevisitwillsendtothesupplierandthecertificationbodythefinalreport:Scope-products-customerspecificrequirementswithissuelevelSummaryofauditedelementsandrelatedresultsNonconformitiesasevidencedduringtheauditprocessOpportunitiesforimprovement50ISO/TS16949AuditActivitiescont’dAuditteam(plusadditionaltechnicalexpertsifany)Cross-referencestosupplierqualitysystemdocumentationNonconformitiesshallbeacknowledgedbythesupplier.Theauditorshallrecordallnonconformitiesidentifiedontheauditreportevenifthecorrectiveactionisimplementedimmediately.51ISO/TS16949AuditActivitiescont’dForeachnonconformitytheSuppliershallperformcorrectiveactionwithinthreemonthsfromtheendofthesitevisit.Thesupplierwillinformtheauditteamofcorrectiveactionsandtargetdateforimplementation.Uponverificationofcorrectiveaction,asupplementaryreportshallbeissuedbytheauditteamtoaccompanythefinalauditreport.52ISO/TS16949AuditActivitiescont’dTheauditteammayproposetothecertificationbodyafollow-upvisitinordertoverifytheimplementationofcorrectiveactions.Certificateswillbeissuedonlyifthereis100%compliancetorequirementswhichmeansthatnonconformitiesfoundduringtheauditare100%resolvedwithinthreemonthsofthestartoftheon-siteaudit.53ISO/TS16949AuditTeamTheauditteamshallprovideafullreportontheoperationsauditedtothesupplierwithin15workingdaysofeachinitialandsurveillanceauditunlessotherwiseagreedbythesupplier.Auditorsshallidentifyopportunitiesforimprovementwithoutrecommendingspecificsolutions.Theseopportunitiesshallbeincludedinthereporttothesupplier.Authorizationtoprovidethefinalreportshallbespecifiedinthecertificationcontractbetweenthecertificationbodyandthesupplier.54ISO/TS16949OtherRequirementsConsultantstothesuppliercannotparticipateintheaudit.CertificationbodiesshallnotifytheIATFofallscheduledauditsincludingwitnessauditsandshallallowIATFmembers,ortheirdesignates,toattend.CertificatestoISO/TS16949shallonlybeissuedbyIATFcontractedcertificationbodyofficesforamaximumvalidityofthreeyears.55ISO/TS16949OtherRequirementscont’dUpgradingofacurrentautomotivecertificate,AVSQ,EAQF,QS-9000,VDA6.1,byoneoftheIATFcontractedcertificationbodieswillbetakenintoaccountpriortotheinitialassessmenttoISO/TS16949,asfollows:Ifthescopeisunchanged,atleast50%oftherequiredauditmandaysforinitialauditshallbeapplied.TheauditmustfullyincludetheISO/TS16949elements4.1,4.2and4.14andthecustomerspecificrequirements,andassesstheremainingISO/TS16949requirementsonasamplingbasis.56OtherRequirementsOtherRequirementscont’dIfthescopeischanged,100%oftherequiredauditmandaysfortheinitialauditshallbeapplied.TheauditmustfullyincludeallISO/TS16949requirements,includingcustomerspecificrequirements;samplingofISO/TS16949requirementsisnotpermitted.IATFreservestherighttosendadelegatetotheexecutivemanagementcommitteeofthecertificationbodyconcerningcertificationdecisionsregardingISO/TS16949.57ISO/TS16949OtherRequirementscont’dIfacertificationbodyplacesanexistingISO/TS16949certifiedcompanyonsuspensionbecauseofqualitysystemnonconformitiesoraviolationoftherulesofregistration,thecertificationbodyshallnotifyIATF,within10workingdays.58ISO/TS16949Goingforward,IATFplansto:beginworkonarevisedISO/TS16949toalignwiththeISO9001year2000text;2000-2001:ISO9000:2000&ISO16949,2ndEdition(harmonizedUS,European,andJapaneseStandard)Thefollowing3slidesrepresentacommuniquéissuedtoallregistrarsonNovember8,200059200020012002200320042005ImplementationofcertificationtoISO/TS2ndedition,relativetoISO9001:2000transitionISO9001:1994ISO9001:2000ISO/TS16949:1999ISO/TS16949:2002StandardslifetimeCertificationvaliditytoISO9001:1994toISO9001:2000toISO/TS16949:1999toISO/TS16949:20023yearsmax(seeIAF-TC176communique)IATFCommunique-October4th200060IATFCommunique-October4th2000Inaccordancewithitsplan,theInternationalAutomotiveTaskForceisworkingonthealignmentofISO/TS16949:1999withISO9001:2000.TherevisedversionofISO/TS16949isexpectedtobepublishedbyMarch2002,inaccordancewiththerequirementsforreviewofanISOTechnicalSpecificationwithinthreeyears.ThetransitionfromthecurrentversionofISO/TS16949willalignwiththearrangementsforintroductionofISO9001:2000,whicharedefinedbyIAF,ISO/TC176andISO/CASCOintheircommuniquedatedSeptember27,1999,referenceISO/TC176N488.CertificationtoISO/TS16949:1999,inaccordancewiththeIATFregistrationscheme,willcontinuetoberecognisedbysubscribingmemberstoIATFthroughoutthetransitionperiodforISO9001:1994toISO9001:2000.TherearenoplanstorevisetheexistingautomotivecataloguesAVSQ94,EAQF94,QS9000,andVDA6.1duringthisperiod.61IATFCommunique-October4th2000Question&answer:Q:IsitpossibletoobtaincertificationtoISO9001:2000incombinationwithIATFrecognisedISO/TS16949:1999certification?A:Yes.Thisisabusinessdecisionforthesupplier.Suchcertificationwouldresultintwoseparatecertificates.Q:Doesthisdualcertificationrequirementseparateaudits?A.No,buttheIATFrulesforcertificationforISO/TS16949:1999mustbeobserved.62ISO/TS16949Theprinciplesdetailedinthiscommuniquéaresupportedbythefollowingvehiclemanufacturers:BMW,Daimler-Chrysler,Fiat,Ford,GeneralMotors(includingOpelVauxhall),PSAPeugeot-Citreon,RenaultSA,VolkswagenandthetradeassociationsAIAG,ANFIA,FIEV,SMMTandVDA.63ISO/TS16949StatementsfromOEM’sDaimlerChryslerRecognitionofVDA6.1andQS-9000StandardsEffectiveimmediately,aspartofourGlobalProcurement&SupplystrategyatDaimlerChrysler,registrationtoeitherVDA6.1orQS-9000,includingcompanyspecificrequirements,willbeacceptedasqualityregistrationfromoursuppliers.64ISO/TS16949DaimlerChryslercont’dRegistrationstoISO/TS16949,includingcompanyspecificswillalsobeacceptedasqualityregistrationfromoursuppliers.ThisnewTechnicalSpecificationmaybecometheQualityManagementstandardofthefuture.65ISO/TS16949FordMotorCompanyOctober7,1999Formanysuppliers,particularlythosewithmultipleinternationalautomotivecustomers,ISO/TS16949mayrepresentsubstantialefficienciesbyallowingoneaudittosatisfythequalitysystemrequirementsofQS-9000,VDA6.1,AVSQ,EAQFwhencoupledwithindividualcompany-specificqualityrequirementsandthecommonautomotiveregistrationscheme.ThenewTechnicalSpecificationmaybecomethesingleautomotiveindustryqualitymanagementstandardofthefuture.66ISO/TS16949AllGeneralMotorsGlobalSuppliersNewISO/TS16949andQS-9000GMCustomer-SpecificRequirementsGMwillaccept,asoptionaltoQS-9000,athirdpartycertificationtoISO/TS16949thatmeetsthefollowingconditions:ThecertificationscopemustincludebothISO/TS16949andtheaccompanyingISO/TS16949GM-CustomerSpecificRequirements.67ISO/TS16949AllGeneralMotorsGlobalSupplierscont’dNotethatG