9ISO9000andMBNQA

ISOTQM-UniversityofMichigan1PatHammett1ISO9000(Auto:QS9000)(U.S.-ANSI/ASQCQ-90Series)MalcolmBaldrigeAwardReferencesforAdditionalInformation:ISO:::(theymakelifesimpler!)nForexample,aninternationalstandardexistsfortheoptimalthicknessofacreditcard(0.76mm).ncompliancewithstandardsallowsproductstobeusedworldwide.ISOTQM-UniversityofMichigan2PatHammett3WhatisISO?nISO-TheInternationalOrganizationforStandardizationnNote:ISOisnotanacronym;itistheprefixisowhichmeans“equal”nISOisaNon-governmentalagency(establishedin1947).nOver100countriesparticipateinISO.nEachcountryhasitsownstandardsorganizationwhichinterfaceswiththeworldwideISOorganization(U.S.representedbyANSI).nISOstandardsoftenreplacenationalstandards.nISOhastechnicalcommitteeswhichinvestigateandpublishstandards.nHeadquartersinGeneva,SwitzerlandnTheuseofinternationalstandardsbeganin1906.nISOOrganizationalGoal-nfacilitatetheinternationalexchangeofgoodsandservices,andtodevelopcooperationamongeconomicactivities.4SomeBenefitsofISOStandardsngreatercompatibilityandinterchangeabilityofgoods&services.nleadtoareductioninthenumberofmodels,thusreducingcosts.nincreasesdistributionefficiency.nimprovesprotectionforhealth&safety.nISOstandardsremove“technicalbarrierstotrade.”nTheyareenablersforglobalcompetitionforbothleadingindustrialnationsanddevelopingcountries.ISOTQM-UniversityofMichigan3PatHammett5WhatdoesanISOStandardLookLike?nItmaybeatechnicalspecification,asetofprocedures,adefinition,atestmethod,orasetofsymbols.nExamplesofISOstandards,nuniversalsystemofmeasurement(SI)---metricsystem(m,kg,s)nsymbolsforautomobilecontrols(headlightswitch)nISOmetricscrewthreads---amajorISOaccomplishmentwastostandardizethedescriptionsofscrewsbytheirthreads.nThissolvedthenumerousmaintenanceproblemsresultingfromthediversityofscrews.nQualitySystemModel(ISO9000Series)6ISO9000BackgroundnISOQualityStandardswerereleasedin1987.nISO9000arenotstandardsforproductsbutarestandardsforoperatingaqualitymanagementsystem.nNote:ISOCertifiedCompaniesindicatethattheyhaveandfollowaqualitysystem,itdoesnotimplytheyhavebetterquality.ISOTQM-UniversityofMichigan4PatHammett7ISOStandardsnISO9000-9004areaseriesofstandards.nISO9000isaguidelineforselectingwhichlevelofcomplianceacompanyshouldseek(ISO9001,ISO9002,orISO9003)nISO9001-3arequalitysystemsguidelinesforcompaniessupplyingn9001-design,development,production,installation,andserviceactivities.n9002-production,installation,andservicingactivities.n9003-finalinspectionandtestactivities.nISO9004-managementmodelforqualitymanagementsystemsnISO8402-providesaqualityvocabulary8ISOCertificationnCertificationisaccomplishedthrough3rdpartyauditors.nCertificationsarebysiteorfacilitynotbycompany.nExample-Individualmanufacturingplantsortechnicalfacilitieswithinacompanyseekcertification.nSitesareauditedontheirqualitymanualsandqualityprocessesnotnecessarilyontheirabilitytomeetqualitycriteria(suchasaCpkcriteria).nCertificationrequiresadocumentedqualitysystemexistsandisfollowed.ISOTQM-UniversityofMichigan5PatHammett9ISO9000SeriesnISO9000SeriesCompliance:nISO9001requirescompliancein20functionalareasnISO9002requirescompliancein19/20areasnnocomplianceintheareaofdesigncontrolnISO9003requirescompliancein16/20areas.nnocomplianceindesigncontrol,purchasing,processcontrol,servicing.nFacilitiesseek9001or9002or9003dependingonactivities.10ISOFunctionalAreas1.ManagementResponsibility11.Controlofinspection,measuring,andtestequipment2.QualitySystem12.Inspectionandteststatus3.ContractReview13.Controlofnonconformingproduct4.DesignControl14.CorrectiveandPreventiveAction5.DocumentandDataControl15.Handling,Storage,Packaging,Delivery6.Purchasing16.ControlofQualityRecords7.ControlofCustomer-SuppliedProduct17.Internalqualityaudit8.ProductIdentificationandTraceability18.Training9.ProcessControl19.Servicing10.InspectionandTesting20.StatisticaltechniquesISOTQM-UniversityofMichigan6PatHammett11ExampleISO9000Standard-4.8Section4.8ProductIdentificationandTraceabilityWhereappropriate,thesuppliershallestablishandmaintaindocumentedproceduresforidentifyingtheproductbysuitablemeansfromreceiptandduringallstagesofproduction,delivery,andinstallation.Whereandtotheextentthattraceabilityisaspecifiedrequirement,thesuppliershallestablishandmaintaindocumentedproceduresforuniqueidentificationofindividualproductorbatches.Thisidentificationshallberecorded(see4.16).Note:endofstandard.ISO9000standardsdonotspecifyhowtotracktraceabilitytheyrequirethatthefacilitydevelopsasystemtodoso.12ISOVs.QS9000nFord,ChryslerandGMhaveaddedrequirementstoISOanddevelopedamorestringentsetofstandards(QS-9000).Examples:ISO9001:Section4.11ControlofInspection,MeasuringandTestEquipment4.11.1GeneralThesuppliershallestablishandmaintaindocumentedprocedurestocontrol,calibrate,andmaintaininspection,measu