质量管理表现改善的系统–指南(1)

ISO9004:2000(E)Qualitymanagementsystems–Guidelinesforperformanceimprovements1ScopeThisInternationalStandardprovidesguidelinesbeyondtherequirementsgiveninISO9001inordertoconsiderboththeeffectivenessadefficiencyofaqualitymanagementsystem,andconsequentlythepotentialforimprovementoftheperformanceofanorganization.WhencomparedtoISO9001,theobjectivesofcustomersatisfactionandproductqualityareextendedtoincludethesatisfactionofinterestedpartiesadtheperformanceoftheorganization.ThisInternationalStandardisapplicabletotheprocessesoftheorganizationandconsequentlythequalitymanagementprinciplesonwhichitisbasedcanbedeployedthroughouttheorganization.ThefocusofthisInternationalStandardistheachievementofongoingimprovement,measuredthroughthesatisfactionofcustomersandotherinterestedparties.ThisInternationalStandardconsistsofguidanceandrecommendationsandisnotintendedforcertification,regulatoryorcontractualuse,norasaguidetotheimplementationofISO9001.2NormativereferenceThefollowingnormativedocumentcontainsprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionofthenormativedocumentindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentreferredtoapplies.MembersofISOandIECmaintainregistersofcurrentlyvalidInternationalStandards.ISO9000:2000,Qualitymanagementsystems–Fundamentalsandvocabulary.3TermsanddefinitionsForthepurposesofthisInternationalStandard,thetermsanddefinitionsgiveninISO9000apply.Thefollowingterms,usedinthiseditionofISO9004todescribethesupply-chain,havebeenchangedtoreflectthevocabularycurrentlyused:supplierorganizationcustomer(interestedparties)ThroughoutthetextofthisInternationalStandard,wherevertheterm“product”occurs,itcaalsomean“service”.ISO9004:2000(E)4Qualitymanagementsystem4.1ManagingsystemsandprocessesLeadingandoperatinganorganizationsuccessfullyrequiresmanagingitinasystematicandvisiblemanner.Successshouldresultfromimplementingandmaintainingamanagementsystemthatisdeignedtocontinuallyimprovetheeffectivenessandefficiencyoftheorganization’sperformancebyconsideringtheneedsofinterestedparties.Managinganorganizationincludesqualitymanagement,amongothermanagementdisciplines.Topmanagementshouldestablishacustomer-orientedorganizationa)bydefiningsystemsandprocessesthatcanbeclearlyunderstood,managedandimprovedineffectivenessawellasefficiency,andb)byensuringeffectiveandefficientoperationandcontrolofprocessesandthemeasuresanddatauseddeterminesatisfactoryperformanceoftheorganization.Examplesofactivitiestoestablishacustomer-orientedorganizationinclude-definingandpromotingprocessesthatleadtoimprovedorganizationalperformance,-acquiringandusingprocessdataandinformationonacontinuingbasis,-directingprogresstowardscontinualimprovement,and-usingsuitablemethodstoevaluateprocessimprovement,suchasself-assessmentsandmanagementreview.Examplesofself-assessmentandcontinualimprovementprocessesaregiveninannexesAandBrespectively.ISO9001:2000,Qualitymanagementsystems–Requirements4Qualitymanagementsystem4.1GeneralrequirementsTheorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandard.Theorganizationshalla)identifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization,b)determinethesequenceandinteractionoftheseprocesses,c)determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective,d)ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringotheseprocesses,e)monitor,measureandanalysetheseprocesses,andf)implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.TheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisInternationalStandard.Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitywithrequirements,theorganizationshallensurecontroloversuchprocesses.Controlofsuchoutsourcedprocessesshallbeidentifiedwithinthequalitymanagementsystem.NOTEProcessesneededforthequalitymanagementsystemreferredtoaboveshouldincludeprocessesformanagementactivities,provisionofresources,productrealizationandmeasurement.ISO9004:2000(E)4.2DocumentationManagementshoulddefinethedocumentation,includingtherelevantrecords,neededtoestablish,implementandmaintainthequalitymanagementsystemandtosupportandeffectiveandefficientoperationoftheorganization’sprocesses.Thenatureandextentofthedocumentationshouldsatisfythecontractual,statutoryandregulatoryrequirements,andtheneedsandexpectationsofcustomersandotherinterestedpartiesandshouldbeappropriatetotheorganization.Documentationmaybeinanyformormediumsuitablefortheneedsoftheorganization.Inordertoprovidedocumentationtosatisfytheneedsandexpectationsofinterestedpartiesmanagementsh