ISO9001：2000全英文(ppt 39).ppt

ISO9001:2000,Objective,IntroducetheconceptofnewISO9001Standard,Highlightimportantareasandchangesofthenewstandard,Brieflyintroducethesystemrequirementsofthenewstandard,WhatisISO9001:2000,2ndrevisionofQualityManagementSystemRequirementStandardfromInternationalOrganizationforStandards,ReplacementforpreviousISO9001/9002and9003standardsof1994,Introducedconsiderableconceptualchanges,ApplicabletoalltypesofOrganizationswithpossiblepermissibleomissionsofcertainrequirements,NewISO9001,QMS,Resourcemanagement,Measurement,analysis&improvements,ProductRealization,ManagementResponsibility,ContinualImprovementcycle,ISO9001:2000Model,CUSTOMERS,CUSTOMERS,QualityManagementSystem,5.ManagementResponsibility,7.ProductRealization,6.ResourceManagement,8.MeasurementAnalysisandImprovement,Requirements,Satisfaction,ContinualImprovementoftheQualityManagementSystem,Consumption,Product,Principlesofnewstandard,Basedoneightqualitymanagementprinciples,Leadership,Processapproach,Involvementofpeople,SystemapproachtoManagement,Continualimprovement,Factualapproachtodecisionmaking,Mutualbeneficialsupplierrelationship,Customerfocus,Principlesofnewstandard,CustomerfocusOrganizationdependscustomersUnderstandcurrent&futurecustomerneeds.Meet/exceedcustomerexpectations,LeadershipLeadersestablishpurpose&directionoftheorganizationShouldcreate&maintainenvironmenttoachieveorganizationsobjectives,InvolvementofPeoplePeopleofalllevelsareessenceofanorganizationTheirfullinvolvementfororganizationsbenefit,ProcessapproachDesiredresultsareachievedmoreefficientlywhenactivitiesandresourcesaremanagedasprocess,Principlesofnewstandard,SystemapproachtoManagementIdentifying,understandingandmanaginginterrelatedprocessasasystemcontributestotheorganizationseffectiveness&efficiency,ContinualimprovementsContinualimprovementoftheorganizationsoverallperformanceshouldbeapermanentobjectiveoftheorganization,FactualapproachtodecisionmakingEffectivedecisionsarebasedontheanalysisofdataandinformation,MutuallybeneficialsupplierrelationshipsAnorganization&itssuppliersareinterdependentMutuallybeneficialrelationshipenhancestheabilityofbothtocreatevalue,ExpectationsofthenewStandard,Avoidtheapplicationofsystemsthatareseparatefromtheorganizationsbusinessprocess,EnablethedevelopmentofaQualitysystemthatisfullyintegratedintothenormaloperationsoforganizationsbusiness,EnableContinualimprovementsofthesystemforenhancedcustomersatisfaction,Enablecompliancetostatutory®ulatoryrequirements,Importantchanges,Processapproach,ProcessdefinitionSetofinterrelatedorinteractingactivitieswhichtransformsinputsintooutputs,Ensurecontinualimprovements,Doitforallvalueaddingprocesses,ProcessapproachContinualimprovementsofProcess,PDCACycle,ProcessesintermsOfAddedValueDO,ContinualimprovementsofProcessesbasedonobjectivemeasurementsACTION,MeasureresultsofprocessPerformanceandeffectiveness-ObjectiveMeasurementsCHECK,Understandings&meetingrequirementsPLAN,E.g.-PurchasingProcess,PerformanceMeasurementsDeliverystatusOn-time,Onspec,NCPetcSupplierevaluation,OutputsReceiptofMaterialonrightconditionRightQualityRightQuantityRightTime,SystemRequirements/StructureoftheStandard,4QualityManagementSystem,4-Qualitymanagementsystem,4.1Generalrequirements,Identificationofprocessesrequired,CriteriaandmethodstoensureOperation&control,Availabilityofinformation&resourcesforoperation&control,MonitoringandMeasuringofprocesses,Continualimprovements,4-Qualitymanagementsystem,QualityPolicy,QualityObjectives,QualityManual,ProceduresrequiredbytheStandard,Proceduresrequiredforplanning,operation&controlofOrganizationactivities,Records,4.2Documentrequirements,5-ManagementResponsibility,5.1Managementcommitment,5-ManagementResponsibility,TopManagementscommitment,5-ManagementResponsibility,NewDevelopment,EvidencemustbeprovidedtoshowthattheManagementiscommittedtotheaboverequirements,AuditorscouldspeaktoandauditTopManagement(E.g.MD/Directors)toestablishtheircommitmenttothemanagementsystem,6-ResourceManagement,6.1Provisionofresources,6-ResourceManagement,ResourceManagement,6-HumanResources,Enhanced,6.2HumanResources,7-ProductRealization,7.1Planningofproductrealization,7-ProductRealization,7.1PlanningofProductrealization,7-ProductRealization,7.2Customerrelatedprocesses(Sales),7-ProductRealization,7.3DesignandDevelopment(Product),7-ProductRealization,7.4PurchasingPurchasingisdoneincontrolledmannertoensurethatpurchasedproductsconformstospecificrequirements,7-ProductRealization,7.5ProductionandserviceprovisionManufacturing/serviceprovisionundercontrolledconditiontoensureconformityofproduct,7-ProductRealization,7.6ControlofmonitoringandmeasuringdevicesControlandCalibrationofequipmentsusedformonitoring,inspectionandtesting,8-Measurement,analysisandimprovement,8.1General,8-Measurement,analysisandimprovement,TodemonstrateConformityoftheproductConformitytoQMSrequirementsContinuallyimprovementsandtheeffectivenessofthesystem,8.2-MonitoringandMeasurementsCustomersatisfaction/perceptionInternalaudits-conformityplannedarrangementsofQMSandISO9001Monitoringandmeasurementsofprocessestodetermine/demonstrateabilityofprocessestoachieverequiredresultsMonitoringandmeasurementsofproductConformitytoproductrequirements,8.3-ControlofNCPToassurethatNCPproductsareidentifiedandcontrolledtopreventunintendeduse/delivery,8.1-TodemonstrateConformityoftheproductConformitytoQMSrequirementsContinuallyimprovementsandtheeffectivenessofthesystem,8-Measurement,analysisandimprovement,8.4-AnalysisofdataCollectionandanalysisofdatageneratedthroughQMSactivitiestoverifysuitability,effectivenessandcontinualimprovementofthesystem,AnalysisshallprovideinformationrelatedtoCustomersatisfaction/perceptionConformitytospecs,requirementsTrendsofprocessesandproductsOpportunitiesforpreventiveactionsSuppliers,8-Measurement,analysisandimprovement,8.5-ImprovementsContinualImprovementsQMSneededtobecontinuallyimproved,CorrectiveactionActionstopreventrecurrenceofNCP,NCRetcIncludesreviews,determinationofcauses,needofaction,impl