ISO9000QualityManagementSystem(1)

ISO9000QualityManagementSystem2005-22TheideaanddevelopmentofISO90002.1DevelopmentofqualitymanagementⅠⅡⅢ传统质量管理阶段统计质量管理阶段全面质量管理阶段操作者（自我检查）工长（工长负责）检验员（专职检验）统计（抽样检验）TQEMSTQM20～30’s40～60’s70～80’s2.2TotalqualitymanagementviaISO9000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,Qualitymanagementsystems–FundamentalsandvocabularyISO9001:2000,Qualitymanagementsystems–RequirementsISO9004:2000,Qualitymanagementsystems–GuidelinesforperformanceimprovementsISO19011,GuidelinesonQualityand/orEnvironmentalManagementSystemsAuditing(currentlyunderdevelopment)2.5QualitymanagementprinciplesPrinciple1–CustomerfocusPrinciple2–LeadershipPrinciple3–InvolvementofpeoplePrinciple4–ProcessapproachPrinciple5–SystemapproachtomanagementPrinciple6–ContinualimprovementPrinciple7–FactualapproachtodecisionmakingPrinciple8–MutuallybeneficialsupplierrelationshipsPrinciple1–CustomerfocusOrganizationsdependontheircustomersandthereforeshouldunderstandcurrentandfuturecustomerneeds,shouldmeetcustomerrequirementsandstrivetoexceedcustomerexpectations.Principle2–LeadershipLeadersestablishunityofpurposeanddirectionoftheorganization.Theyshouldcreateandmaintaintheinternalenvironmentinwhichpeoplecanbecomefullyinvolvedinachievingtheorganization’sobjectives.Principle3–InvolvementofpeoplePeopleatalllevelsaretheessenceofanorganizationandtheirfullinvolvementenablestheirabilitiestobeusedfortheorganization'sbenefit.Principle4–ProcessapproachAdesiredresultisachievedmoreefficientlywhenactivitiesandrelatedresourcesaremanagedasaprocess.Principle5–SystemapproachtomanagementIdentifying,understandingandmanaginginterrelatedprocessesasasystemcontributestotheorganization'seffectivenessandefficiencyinachievingitsobjectives.Principle6–ContinualimprovementContinualimprovementoftheorganization'soverallperformanceshouldbeapermanentobjectiveoftheorganization.Principle7–FactualapproachtodecisionmakingEffectivedecisionsarebasedontheanalysisofdataandinformation.Principle8–MutuallybeneficialsupplierrelationshipsAnorganizationanditssuppliersareinterdependentandamutuallybeneficialrelationshipenhancestheabilityofbothtocreatevalue2.6RequirementandMethodsProcessapproachP-D-C-A5W1H:WhatWhyWhoWhenWhereHowISO9001:2000StandardISO9001:2000illustration2.7GuidanceontheProcessApproachtoQualityManagementSystemsProcessApproach:adesiredresultisachievedmoreefficientlywhenactivitiesandrelatedresourcesaremanagedasaprocess.ISO9000:2000clause3.4.1definesaProcessas:SetofinterrelatedorinteractingactivitieswhichtransformsinputsintooutputsNOTE1Inputstoaprocessaregenerallyoutputsofotherprocesses.NOTE2Processesinanorganization(3.3.1)aregenerallyplannedandcarriedoutundercontrolledconditionstoaddvalue.SchematicrepresentationofaProcessThePlan-Do-Check-ActcycleThePlan-Do-Check-ActcycleThePlan-Do-Check-Actcyclewasfirstdevelopedinthe1920'sbyWalterShewhart,andwaspopularisedlaterbyW.EdwardsDeming.ForthatreasonitisoftenreferredtoasTheDemingCycle.ExtensiveliteratureexistsaboutthePDCAcycleinnumerouslanguages,andusersoftheISO9000:2000familyofstandardsareencouragedtoconsultthisforadeeperunderstandingoftheconcept.ThePDCAconceptissomethingthatispresentinallareasofourprofessionalandpersonallives,andisusedcontinually,eitherformallyofinformally,consciouslyorsub-consciouslyineverythingwedo.Everyactivity,nomatterhowsimpleorhowcomplex,fallsintothisnever-endingpattern:TypicalnetworkofinteractingprocessesFig1.Modelofaprocess-basedqualitymanagementsystem(TakenfromISO9000:2000)ImplementationoftheProcessApproachinrelationtoISO9001:2000RequirementsClause0.2intheintroductionofISO9001:2000states,referringtotheprocessapproach:Whenusedwithinaqualitymanagementsystemprocess,suchanapproachemphasizestheimportanceof:a)theunderstandingandmeetingofrequirements,b)theneedtoconsiderprocessesintermsofaddedvalue,c)obtainingresultsofprocessperformanceandeffectiveness,andd)continualimprovementofprocessesbasedonobjectivemeasurement.2.8DocumentDefinitions:informationanditssupportingmediumClause4.2.1Generalexplainsthatthequalitymanagementsystemdocumentationshallinclude:documentedstatementsofaqualitypolicyandqualityobjectives;aqualitymanualdocumentedproceduresrequiredbythisInternationalStandarddocumentsneededbytheorganizationtoensuretheeffectiveplanning,operationandcontrolofitsprocesses,andrecordsrequiredbythisInternationalStandard;themainobjectivesofanorganization’sdocumentationa)CommunicationofInformationasatoolforinformationtransmissionandcommunication.Thetypeandextentofthedocumentationwilldependonthenatureoftheorga