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首页 iso 9000-2005

iso 9000-2005.pdf

iso 9000-2005

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2010-01-19 0人阅读 举报 0 0 暂无简介

简介:本文档为《iso 9000-2005pdf》,可适用于企业制度领域

INTERNATIONALSTANDARDISOThirdeditionReferencenumberISO:(E)©ISOQualitymanagementsystemsFundamentalsandvocabularySystèmesdemanagementdelaqualitéPrincipesessentielsetvocabulaireISO:(E)ii©ISO–AllrightsreservedPDFdisclaimerThisPDFfilemaycontainembeddedtypefacesInaccordancewithAdobe'slicensingpolicy,thisfilemaybeprintedorviewedbutshallnotbeeditedunlessthetypefaceswhichareembeddedarelicensedtoandinstalledonthecomputerperformingtheeditingIndownloadingthisfile,partiesacceptthereintheresponsibilityofnotinfringingAdobe'slicensingpolicyTheISOCentralSecretariatacceptsnoliabilityinthisareaAdobeisatrademarkofAdobeSystemsIncorporatedDetailsofthesoftwareproductsusedtocreatethisPDFfilecanbefoundintheGeneralInforelativetothefilethePDFcreationparameterswereoptimizedforprintingEverycarehasbeentakentoensurethatthefileissuitableforusebyISOmemberbodiesIntheunlikelyeventthataproblemrelatingtoitisfound,pleaseinformtheCentralSecretariatattheaddressgivenbelow©ISOAllrightsreservedUnlessotherwisespecified,nopartofthispublicationmaybereproducedorutilizedinanyformorbyanymeans,electronicormechanical,includingphotocopyingandmicrofilm,withoutpermissioninwritingfromeitherISOattheaddressbeloworISO'smemberbodyinthecountryoftherequesterISOcopyrightofficeCasepostale•CHGenevaTelFaxEmailcopyrightisoorgWebwwwisoorgPublishedinSwitzerlandISO:(E)©ISO–AllrightsreservediiiContentsPageScopeFundamentalsofqualitymanagementsystemsRationaleforqualitymanagementsystemsRequirementsforqualitymanagementsystemsandrequirementsforproductsQualitymanagementsystemsapproachTheprocessapproachQualitypolicyandqualityobjectivesRoleoftopmanagementwithinthequalitymanagementsystemDocumentationEvaluatingqualitymanagementsystemsContinualimprovementRoleofstatisticaltechniquesQualitymanagementsystemsandothermanagementsystemfocusesRelationshipbetweenqualitymanagementsystemsandexcellencemodelsTermsanddefinitionsTermsrelatingtoqualityTermsrelatingtomanagementTermsrelatingtoorganizationTermsrelatingtoprocessandproductTermsrelatingtocharacteristicsTermsrelatingtoconformityTermsrelatingtodocumentationTermsrelatingtoexaminationTermsrelatingtoauditTermsrelatingtoqualitymanagementormeasurementprocessesAnnexA(informative)MethodologyusedinthedevelopmentofthevocabularyBibliographyAlphabeticalindexISO:(E)iv©ISO–AllrightsreservedForewordISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies)TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommitteesEachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommitteeInternationalorganizations,governmentalandnongovernmental,inliaisonwithISO,alsotakepartintheworkISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardizationInternationalStandardsaredraftedinaccordancewiththerulesgivenintheISOIECDirectives,PartThemaintaskoftechnicalcommitteesistoprepareInternationalStandardsDraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvotingPublicationasanInternationalStandardrequiresapprovalbyatleastofthememberbodiescastingavoteAttentionisdrawntothepossibilitythatsomeoftheelementsofthisdocumentmaybethesubjectofpatentrightsISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrightsISOwaspreparedbyTechnicalCommitteeISOTC,Qualitymanagementandqualityassurance,SubcommitteeSC,ConceptsandterminologyThisthirdeditioncancelsandreplacesthesecondedition(ISO:)ItincludesthechangesacceptedintheDraftAmendmentISODAM:AnnexAincludesconceptdiagramsthatprovideagraphicalrepresentationoftherelationshipsbetweentermsinspecificfieldsrelativetoqualitymanagementsystemsISO:(E)©ISO–AllrightsreservedvIntroductionGeneralTheISOfamilyofstandardslistedbelowhasbeendevelopedtoassistorganizations,ofalltypesandsizes,toimplementandoperateeffectivequalitymanagementsystemsISOdescribesfundamentalsofqualitymanagementsystemsandspecifiestheterminologyforqualitymanagementsystemsISOspecifiesrequirementsforaqualitymanagementsystemwhereanorganizationneedstodemonstrateitsabilitytoprovideproductsthatfulfilcustomerandapplicableregulatoryrequirementsandaimstoenhancecustomersatisfactionISOprovidesguidelinesthatconsiderboththeeffectivenessandefficiencyofthequalitymanagementsystemTheaimofthisstandardisimprovementoftheperformanceoftheorganizationandsatisfactionofcustomersandotherinterestedpartiesISOprovidesguidanceonauditingqualityandenvironmentalmanagementsystemsTogethertheyformacoherentsetofqualitymanagementsystemstandardsfacilitatingmutualunderstandinginnationalandinternationaltradeQualitymanagementprinciplesToleadandoperateanorganizationsuccessfully,itisnecessarytodirectandcontrolitinasystematicandtransparentmannerSuccesscanresultfromimplementingandmaintainingamanagementsystemthatisdesignedtocontinuallyimproveperformancewhileaddressingtheneedsofallinterestedpartiesManaginganorganizationencompassesqualitymanagementamongstothermanagementdisciplinesEightqualitymanagementprincipleshavebeenidentifiedthatcanbeusedbytopmanagementinordertoleadtheorganizationtowardsimprovedperformancea)CustomerfocusOrganizationsdependontheircustomersandthereforeshouldunderstandcurrentandfuturecustomerneeds,shouldmeetcustomerrequirementsandstrivetoexceedcustomerexpectationsb)LeadershipLeadersestablishunityofpurposeanddirectionoftheorganizationTheyshouldcreateandmaintaintheinternalenvironmentinwhichpeoplecanbecomefullyinvolvedinachievingtheorganization'sobjectivesc)InvolvementofpeoplePeopleatalllevelsaretheessenceofanorganizationandtheirfullinvolvementenablestheirabilitiestobeusedfortheorganization'sbenefitd)ProcessapproachAdesiredresultisachievedmoreefficientlywhenactivitiesandrelatedresourcesaremanagedasaprocesse)SystemapproachtomanagementIdentifying,understandingandmanaginginterrelatedprocessesasasystemcontributestotheorganization'seffectivenessandefficiencyinachievingitsobjectivesISO:(E)vi©ISO–Allrightsreservedf)ContinualimprovementContinualimprovementoftheorganization'soverallperformanceshouldbeapermanentobjectiveoftheorganizationg)FactualapproachtodecisionmakingEffectivedecisionsarebasedontheanalysisofdataandinformationh)MutuallybeneficialsupplierrelationshipsAnorganizationanditssuppliersareinterdependentandamutuallybeneficialrelationshipenhancestheabilityofbothtocreatevalueTheseeightqualitymanagementprinciplesformthebasisforthequalitymanagementsystemstandardswithintheISOfamilyINTERNATIONALSTANDARDISO:(E)©ISO–AllrightsreservedQualitymanagementsystemsFundamentalsandvocabularyScopeThisInternationalStandarddescribesfundamentalsofqualitymanagementsystems,whichformthesubjectoftheISOfamily,anddefinesrelatedtermsThisInternationalStandardisapplicabletothefollowing:a)organizationsseekingadvantagethroughtheimplementationofaqualitymanagementsystemb)organizationsseekingconfidencefromtheirsuppliersthattheirproductrequirementswillbesatisfiedc)usersoftheproductsd)thoseconcernedwithamutualunderstandingoftheterminologyusedinqualitymanagement(egsuppliers,customers,regulators)e)thoseinternalorexternaltotheorganizationwhoassessthequalitymanagementsystemoraudititforconformitywiththerequirementsofISO(egauditors,regulators,certificationregistrationbodies)f)thoseinternalorexternaltotheorganizationwhogiveadviceortrainingonthequalitymanagementsystemappropriatetothatorganizationg)developersofrelatedstandardsFundamentalsofqualitymanagementsystemsRationaleforqualitymanagementsystemsQualitymanagementsystemscanassistorganizationsinenhancingcustomersatisfactionCustomersrequireproductswithcharacteristicsthatsatisfytheirneedsandexpectationsTheseneedsandexpectationsareexpressedinproductspecificationsandcollectivelyreferredtoascustomerrequirementsCustomerrequirementsmaybespecifiedcontractuallybythecustomerormaybedeterminedbytheorganizationitselfIneithercase,thecustomerultimatelydeterminestheacceptabilityoftheproductBecausecustomerneedsandexpectationsarechanging,andbecauseofcompetitivepressuresandtechnicaladvances,organizationsaredriventoimprovecontinuallytheirproductsandprocessesThequalitymanagementsystemapproachencouragesorganizationstoanalysecustomerrequirements,definetheprocessesthatcontributetotheachievementofaproductwhichisacceptabletothecustomer,andkeeptheseprocessesundercontrolAqualitymanagementsystemcanprovidetheframeworkforcontinualimprovementtoincreasetheprobabilityofenhancingcustomersatisfactionandthesatisfactionofotherinterestedpartiesItprovidesconfidencetotheorganizationanditscustomersthatitisabletoprovideproductsthatconsistentlyfulfilrequirementsRequirementsforqualitymanagementsystemsandrequirementsforproductsTheISOfamilydistinguishesbetweenrequirementsforqualitymanagementsystemsandrequirementsforproductsRequirementsforqualitymanagementsystemsarespecifiedinISORequirementsforqualitymanagementsystemsaregenericandapplicabletoorganizationsinanyindustryoreconomicsectorregardlessoftheofferedproductcategoryISOitselfdoesnotestablishrequirementsforproductsISO:(E)©ISO–AllrightsreservedRequirementsforproductscanbespecifiedbycustomersorbytheorganizationinanticipationofcustomerrequirements,orbyregulationTherequirementsforproductsandinsomecasesassociatedprocessescanbecontainedin,forexample,technicalspecifications,productstandards,processstandards,contractualagreementsandregulatoryrequirementsQualitymanagementsystemsapproachAnapproachtodevelopingandimplementingaqualitymanagementsystemconsistsofseveralstepsincludingthefollowing:a)determiningtheneedsandexpectationsofcustomersandotherinterestedpartiesb)establishingthequalitypolicyandqualityobjectivesoftheorganizationc)determiningtheprocessesandresponsibilitiesnecessarytoattainthequalityobjectivesd)determiningandprovidingtheresourcesnecessarytoattainthequalityobjectivese)establishingmethodstomeasuretheeffectivenessandefficiencyofeachprocessf)applyingthesemeasurestodeterminetheeffectivenessandefficiencyofeachprocessg)determiningmeansofpreventingnonconformitiesandeliminatingtheircausesh)establishingandapplyingaprocessforcontinualimprovementofthequalitymanagementsystemSuchanapproachisalsoapplicabletomaintainingandimprovinganexistingqualitymanagementsystemAnorganizationthatadoptstheaboveapproachcreatesconfidenceinthecapabilityofitsprocessesandthequalityofitsproducts,andprovidesabasisforcontinualimprovementThiscanleadtoincreasedsatisfactionofcustomersandotherinterestedpartiesandtothesuccessoftheorganizationTheprocessapproachAnyactivity,orsetofactivities,thatusesresourcestotransforminputstooutputscanbeconsideredasaprocessFororganizationstofunctioneffectively,theyhavetoidentifyandmanagenumerousinterrelatedandinteractingprocessesOften,theoutputfromoneprocesswilldirectlyformtheinputintothenextprocessThesystematicidentificationandmanagementoftheprocessesemployedwithinanorganizationandparticularlytheinteractionsbetweensuchprocessesisreferredtoasthe“processapproach”TheintentofthisInternationalStandardistoencouragetheadoptionoftheprocessapproachtomanageanorganizationFigureillustratestheprocessbasedqualitymanagementsystemdescribedintheISOfamilyofstandardsThisillustrationshowsthatinterestedpartiesplayasignificantroleinprovidinginputstotheorganizationMonitoringthesatisfactionofinterestedpartiesrequirestheevaluationofinformationrelatingtotheperceptionofinterestedpartiesastotheextenttowhichtheirneedsandexpectationshavebeenmetThemodelshowninFiguredoesnotshowprocessesatadetailedlevelQualitypolicyandqualityobjectivesQualitypolicyandqualityobjectivesareestablishedtoprovideafocustodirecttheorganizationBothdeterminethedesiredresultsandassisttheorganizationtoapplyitsresourcestoachievetheseresultsThequalitypolicyprovidesaframeworkforestablishingandreviewingqualityobjectivesThequalityobjectivesneedtobeconsistentwiththequalitypolicyandthecommitmenttocontinualimprovement,andtheirachievementneedstobemeasurableTheachievementofqualityobjectivescanhaveapositiveimpactonproductquality,operationaleffectivenessandfinancialperformanceandthusonthesatisfactionandconfidenceofinterestedpartiesISO:(E)©ISO–AllrightsreservedRoleoftopmanagementwithinthequalitymanagementsystemThroughleadershipandactions,topmanagementcancreateanenvironmentwherepeoplearefullyinvolvedandinwhichaqualitymanagementsystemcanoperateeffectivelyThequalitymanagementprinciples(see)canbeusedbytopmanagementasthebasisofitsrole,whichisasfollows:a)toestablishandmaintainthequalitypolicyandqualityobjectivesoftheorganizationb)topromotethequalitypolicyandqualityobjectivesthroughouttheorganizationtoincreaseawareness,motivationandinvolvementc)toensurefocusoncustomerrequirementsthroughouttheorganizationd)toensurethatappropriateprocessesareimplementedtoenablerequirementsofcustomersandotherinterestedpartiestobefulfilledandqualityobjectivestobeachievede)toensurethataneffectiveandefficientqualitymanagementsystemisestablished,implementedandmaintainedtoachievethesequalityobjectivesf)toensuretheavailabilityofnecessaryresourcesg)toreviewthequalitymanagementsystemperiodicallyh)todecideonactionsregardingthequalitypolicyandqualityobjectivesi)todecideonactionsforimprovementofthequalitymanagementsystemNOTEStatementsinparenthesesdonotapplytoISOFigureModelofaprocessbasedqualitymanagementsystemISO:(E)©ISO–AllrightsreservedDocumentationValueofdocumentationDocumentationenablescommunicationofintentandconsistencyofactionItsusecontributestoa)achievementofconformitytocustomerrequirementsandqualityimprovement,b)provisionofappropriatetraining,c)repeatabilityandtraceability,d)provisionofobjectiveevidence,ande)evaluationoftheeffectivenessandcontinuingsuitabilityofthequalitymanagementsystemGenerationofdocumentationshouldnotbeanendinitselfbutshouldbeavalueaddingactivityTypesofdocumentusedinqualitymanagementsystemsThefollowingtypesofdocumentareusedinqualitymanagementsystems:a)documentsthatprovideconsistentinformation,bothinternallyandexternally,abouttheorganization'squalitymanagementsystemsuchdocumentsarereferredtoasqualitymanualsb)documentsthatdescribehowthequalitymanagementsystemisappliedtoaspecificproduct,projectorcontractsuchdocumentsarereferredtoasqualityplansc)documentsstatingrequirementssuchdocumentsarereferredtoasspecificationsd)documentsstatingrecommendationsorsuggestionssuchdocumentsarereferredtoas

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