Introduction on ISO 9000 Series Standards英文.ppt

IntroductiononISO9000SeriesStandards,WhatisISO?,InternationalOrganizationforStandardizationWorldwidefederationofnationalstandardsbodiesNon-governmentalorganizationEstablishedin1947,ISO:ManagementSystemStandards,Two“ManagementSystem”standards:ISO9000QualityISO14000EnvironmentalProvidemodelforsettingup&operatingmanagementsystemBuiltonfirmfoundationofstate-of-the-artpractices,ISO9000FamilyStandards:2000,ISO9000:QMS-FundamentalsandVocabularyISO9001:QMS-RequirementsISO9004:QMS-GuidelinesforPerformanceImprovementsISO19011:GuidelinesforQMS&EMSAudit,ISO9000RegistrationsWorldwide,Source:www.iso.ch,ISO9000FamilyStandards:2000,EightQMprinciplesWhatisthemostimportantprinciple?Andwhy?,Process-basedQMSmodel,MajorcontentsofISO9001:2000,4QualityManagementSystem4.1GeneralRequirements4.2DocumentationRequirements4.2.1General4.2.2QualityManual4.2.3ControlofDocuments4.2.4ControlofRecords,MajorcontentsofISO9001:2000,5ManagementResponsibility5.1ManagementCommitment5.2CustomerFocus5.3QualityPolicy5.4Planning5.4.1QualityObjectives5.4.2Qualitymanagementsystemplanning,MajorcontentsofISO9001:2000,5ManagementResponsibility5.5ResponsibilityAuthorityandCommunication5.5.1ResponsibilityandAuthority5.5.2ManagementRepresentative5.5.3Internalcommunication5.6ManagementReview5.6.1General5.6.2Reviewinputs5.6.3Reviewoutputs,MajorcontentsofISO9001:2000,6ResourceManagement6.1ProvisionofResources6.2HumanResources6.2.1General6.2.2Competence,awarenessandtraining6.3Infrastructure6.4WorkEnvironment,MajorcontentsofISO9001:2000,7ProductRealization7.1PlanningofProductRealization7.2CustomerRelatedProcesses7.2.1Determinationofrequirementsrelatedtotheproduct7.2.2Reviewofproductrequirements7.2.3CustomerCommunication,MajorcontentsofISO9001:2000,7ProductRealization7.3DesignandDevelopment(D&D)7.3.1PlanningofD&D7.3.2InputsofD&D7.3.3OutputsofD&D7.3.4ReviewofD&D7.3.5VerificationofD&D7.3.6ConfirmationofD&D7.3.7ControlofchangesinD&D,MajorcontentsofISO9001:2000,7ProductRealization7.4Purchasing7.4.1PurchasingProcess7.4.2PurchasingInformation7.4.3Verificationofpurchasedproduct7.5ProductionandServiceProvision7.5.1Controlofprocesses7.5.2Validationofprocesses7.5.3IdentificationandTraceability7.5.4CustomerProperty7.5.5PreservationofProduct7.6ControlofMonitoringandMeasuringDevices,MajorcontentsofISO9001:2000,8Measurement,Analysis&Improvement8.1General8.2MonitoringandMeasurement8.2.1CustomerSatisfaction8.2.2InternalAudit8.2.3MonitoringandMeasurementofProcesses8.2.4MonitoringandMeasurementofProduct,MajorcontentsofISO9001:2000,8Measurement,Analysis&Improvement8.3ControlofNonConformingProduct8.4AnalysisofData8.5Improvement8.5.1ContinualImprovement8.5.2CorrectiveAction8.5.3PreventiveAction,InteractionofkeyelementsunderISO9001:2000,EstablishingQMS,WhentoestablishQMS?-gainaccesstotheinternationalmarket-createorstrengthenthebrand-clear/standardize/improvetheinternalprocesses-moreemphasisonqualityandthecultureconcerned,EstablishingQMS,PDCA-Demingscontribution-baseofprocessimprovement,Deming,StepstoISO9001Registration,IdentifykeyprocessesDesign&documentsystemImplementandoperatesystemInternalauditsRegistrarauditMaintainregistration,StepstoRegistration,1.Identifykeyprocesses“Processmap”showsrelationshipbetweenprocessesthroughoutorganization,QMSModelforAIOUsExternalMBADegreeProgram,StepstoRegistration,2.Design&documentsystemDocumentationQualityPolicies&ObjectivesQualityManualProceduredocumentsSupportivedocuments:WorkInstructions,RegulationsQualityRecords-demonstrateconformancetosystem,StepstoRegistration,3.ImplementandoperatesystemCommunicatethroughoutorganizationDepartmentsperformworkasdescribedinprocedures,StepstoRegistration,4.InternalAuditsTrainedInternalAuditorsDocumentedinternalauditplanAuditresultsreviewedbymanagementMakecorrections&improvementstoqualitysystem,StepstoRegistration,5.RegistrarAuditDocumentationreviewedbyauditorRegistrarsendsauditteamOn-siteaudittypically2-3daysAuditorsverifythatsystemoperatesasoutlinedinproceduremanualRecommendforregistrationCertificateissued,ThirdPartyRegistrationSystem,StepstoRegistration,6.MaintainRegistrationContinuetooperatequalitysystemSurveillanceaudits(annual/semi-annual)3-yearcycle,CFSORegistration:KeyMilestones,December31,2002:QualityManagementSystemDocumentationcompleted(HeadOffice)January31,2003:InternalAuditteamtrained,CFSORegistration:KeyMilestones,April30,2003:InternalAuditscompletedonallQualitySystemProceduresJune30,2003:ISO9001Registrationachieved(HeadOffice),CFSORegistration:KeyMilestones,December31,2003:QualityManagementSystemDocumentationcompleted(RegionalCenters)June30,2004:ISO9001RegistrationexpandedtoRegionalCenters(SampleBasis),ArgumentabouttheStandardseffectiveness,AnissuethathaslongoccupiedboththebusinessworldandresearchersiswhetherthedevelopmentandcertificationofaqualitymanagementsystemaccordingtoISO9000standardscanfinallyguaranteerealimprovementtothecertifiedorganizations.,ArgumentabouttheStandardseffectiveness,Literaturereviewonthestandardseffectivenessrevealstwoschoolsofthought.OneschoolofthoughtsupportsthatthestandardsofferagoodfirststeptowardsTQMandbusinessexcellence,whiletheotherschoolofthoughtisbasedontheviewthatorganizationsaremainlyinterestedinquickandeasycertificationwithoutrealcommitmenttoquality,leadingtothedevelopmentof“static”qualitysystemsthatcannotguaranteecustomersatisfactionTsiotras&Gotzamani,1996,ArgumentabouttheStandardseffectiveness,TherevisedISO9000:2000versionismuchclosertothebusinessexcellencemodels.ThenewseriesisbasedonasetofqualitymanagementprinciplesthathaveagooddealincommonwiththeprinciplesofTQM,andthereisaremarkableconvergencewiththequalitymanagementprinciplesofthemostpopularbusinessexcellencemodels.Infact,theBaldrigecriteriahavehadaprofoundeffectontheISO9001:2000revisionHampton,2000andasaresult,thenewISO9000:2000requirementsaremorecustomer,processandcontinuousimprovementoriented.,ArgumentabouttheStandardseffectiveness,However,thereareseriousdoubtsandreservationsagainconcerningthedegreetowhichthenewstandardswillreallyboostcompaniesperformancemorethanthepreviousonesBendell,2000,Biazzo&Bernardi,2003,Costa&Martinez-Lorente,2003,Janas&Luczac,2002,Larsen&Haversjo,2000,Laszlo,2000,Wealleans,2002,WhatOthersSay,“ISO9001hashelpedmanagementestablishatransparentinternalorganizationthatiscleartoallemployees.”WieslawVicUzieblo,DirectorofMarketing,Protektor,Poland,WhatOthersSay,”Eachdollarinvestedgeneratesatleastafour-foldreturnifthestandardisimplementedwell.”RobertDor,CoordinatorforServiceQuality,MunicipalityofSaint-Augustin-de-Desmaures,Canada,WhatOthersSay,“AtIBM,theISO9000standardshaveproventobeatemplateforthecreationofasoundqualitysystem.ByembarkingontheISO9000journey,itisreasonabletoexpectlowercosts,improvedcustomersatisfaction,greaterbrandloyalty,andstrongermarketperformanceassociatedwiththisqualityeffort.”Dr.JackE.Small,DirectorISO9000,IBM,USA,Caseofthefranchisedcardealer-supplychainview,Managementresponsibility-Qualitypolicy,Caseofthefranchisedcardealer-supplychainview,Resourcemanagement-Supplyofresources-Infrastructureandworkenvironment,Caseofthefranchisedcardealer-supplychainview,Productrealization-Identificationofrequirementsrelevanttothepr