ISO9000QualityManagementSystem.ppt

ISO9000QualityManagementSystem,2005-2,2TheideaanddevelopmentofISO90002.1Developmentofqualitymanagement,2.2TotalqualitymanagementviaISO9000,全面质量管理（TQM）一个组织以质量为中心，以全员参与为基础，目的在以通过让顾客满意和本组织所有成员及社会受益而达到长期成功的管理途径。全面质量管理源于美国，费根堡姆博士于1961年出版的全面质量管理一书中首次提出TQM。60年代以后，日本大力推行TQM并取得显著成效，引起世界瞩目，在发达国家很快得到发展，形成全面质量管理学科。87年颁布ISO9000族系列标准，使TQM更加完善，形成一门崭新的学科，具有自己的理论、方法和体系。TQM是ISO9000产生的基础，ISO9000是TQM深化的基础，将TQM推向科学化、规范化和标准化。互为基础、不断促进、互为深化。,2.3DevelopmentofISO9000,工业生产的规模化、现代化、标准化，贸易全球化，社会进步、质量要求的不断提高、市场竞争加激等诸因素促进了质量认证的发展。80年ISO/IEC176技术委员会开始工作，87年首次颁布ISO9000族系列标准。1994年“有限修改”，发布实施94版ISO9000族标准。2000年在总体结构和技术内容上作较大的全新修改，2000年12月28日发布2000版ISO9000族标准，2001年6月1日实施）,2.4FourCoreStandards,ISO9000:2000,QualitymanagementsystemsFundamentalsandvocabularyISO9001:2000,QualitymanagementsystemsRequirementsISO9004:2000,QualitymanagementsystemsGuidelinesforperformanceimprovementsISO19011,GuidelinesonQualityand/orEnvironmentalManagementSystemsAuditing(currentlyunderdevelopment),2.5Qualitymanagementprinciples,Principle1CustomerfocusPrinciple2LeadershipPrinciple3InvolvementofpeoplePrinciple4ProcessapproachPrinciple5SystemapproachtomanagementPrinciple6ContinualimprovementPrinciple7FactualapproachtodecisionmakingPrinciple8Mutuallybeneficialsupplierrelationships,Principle1Customerfocus,Organizationsdependontheircustomersandthereforeshouldunderstandcurrentandfuturecustomerneeds,shouldmeetcustomerrequirementsandstrivetoexceedcustomerexpectations.,Principle2Leadership,Leadersestablishunityofpurposeanddirectionoftheorganization.Theyshouldcreateandmaintaintheinternalenvironmentinwhichpeoplecanbecomefullyinvolvedinachievingtheorganizationsobjectives.,Principle3Involvementofpeople,Peopleatalllevelsaretheessenceofanorganizationandtheirfullinvolvementenablestheirabilitiestobeusedfortheorganizationsbenefit.Principle4ProcessapproachAdesiredresultisachievedmoreefficientlywhenactivitiesandrelatedresourcesaremanagedasaprocess.,Principle5Systemapproachtomanagement,Identifying,understandingandmanaginginterrelatedprocessesasasystemcontributestotheorganizationseffectivenessandefficiencyinachievingitsobjectives.Principle6ContinualimprovementContinualimprovementoftheorganizationsoverallperformanceshouldbeapermanentobjectiveoftheorganization.,Principle7Factualapproachtodecisionmaking,Effectivedecisionsarebasedontheanalysisofdataandinformation.Principle8MutuallybeneficialsupplierrelationshipsAnorganizationanditssuppliersareinterdependentandamutuallybeneficialrelationshipenhancestheabilityofbothtocreatevalue,2.6RequirementandMethods,ProcessapproachP-D-C-A5W1H:WhatWhyWhoWhenWhereHowISO9001:2000StandardISO9001:2000illustration,2.7GuidanceontheProcessApproachtoQualityManagementSystems,ProcessApproach:adesiredresultisachievedmoreefficientlywhenactivitiesandrelatedresourcesaremanagedasaprocess.ISO9000:2000clause3.4.1definesaProcessas:SetofinterrelatedorinteractingactivitieswhichtransformsinputsintooutputsNOTE1Inputstoaprocessaregenerallyoutputsofotherprocesses.NOTE2Processesinanorganization(3.3.1)aregenerallyplannedandcarriedoutundercontrolledconditionstoaddvalue.,SchematicrepresentationofaProcess,ThePlan-Do-Check-Actcycle,ThePlan-Do-Check-Actcycle,ThePlan-Do-Check-Actcyclewasfirstdevelopedinthe1920sbyWalterShewhart,andwaspopularisedlaterbyW.EdwardsDeming.ForthatreasonitisoftenreferredtoasTheDemingCycle.ExtensiveliteratureexistsaboutthePDCAcycleinnumerouslanguages,andusersoftheISO9000:2000familyofstandardsareencouragedtoconsultthisforadeeperunderstandingoftheconcept.ThePDCAconceptissomethingthatispresentinallareasofourprofessionalandpersonallives,andisusedcontinually,eitherformallyofinformally,consciouslyorsub-consciouslyineverythingwedo.Everyactivity,nomatterhowsimpleorhowcomplex,fallsintothisnever-endingpattern:,Typicalnetworkofinteractingprocesses,Fig1.Modelofaprocess-basedqualitymanagementsystem(TakenfromISO9000:2000),ImplementationoftheProcessApproachinrelationtoISO9001:2000Requirements,Clause0.2intheintroductionofISO9001:2000states,referringtotheprocessapproach:Whenusedwithinaqualitymanagementsystemprocess,suchanapproachemphasizestheimportanceof:a)theunderstandingandmeetingofrequirements,b)theneedtoconsiderprocessesintermsofaddedvalue,c)obtainingresultsofprocessperformanceandeffectiveness,andd)continualimprovementofprocessesbasedonobjectivemeasurement.,2.8Document,Definitions:informationanditssupportingmediumClause4.2.1Generalexplainsthatthequalitymanagementsystemdocumentationshallinclude:documentedstatementsofaqualitypolicyandqualityobjectives;aqualitymanualdocumentedproceduresrequiredbythisInternationalStandarddocumentsneededbytheorganizationtoensuretheeffectiveplanning,operationandcontrolofitsprocesses,andrecordsrequiredbythisInternationalStandard;,themainobjectivesofanorganizationsdocumentation,a)CommunicationofInformationasatoolforinformationtransmissionandcommunication.Thetypeandextentofthedocumentationwilldependonthenatureoftheorganizationsproductsandprocesses,thedegreeofformalityofcommunicationsystemsandthelevelofcommunicationskillswithintheorganization,andtheorganizationalculture.b)Evidenceofconformityprovisionofevidencethatwhatwasplanned,hasactuallybeendone.c)Knowledgesharinginordertodisseminateandpreserv