质量管理表现改善的系统–指南英文

1、Qualitymanagementsystems-GuidelinesforperformanceimprovementsScopeThisInternationalStandardprovidesguidelinesbeyondtherequirementsgiveninISO9001inordertoconsiderboththeeffectivenessadefficiencyofaqualitymanagementsystem,andconsequentlythepotentialforimprovementoftheperformanceofanorganization.Whenco

2、mparedtoISO9001,theobjectivesofcustomersatisfactionandproductqualityareextendedtoincludethesatisfactionofinterestedpartiesadtheperformanceoftheorganization.ThisInternationalStandardisapplicabletotheprocessesoftheorganizationandconsequentlythequalitymanagementprinciplesonwhichitisbasedcanbedeployedth

3、roughouttheorganization.ThefocusofthisInternationalStandardistheachievementofongoingimprovement,measuredthroughthesatisfactionofcustomersandotherinterestedparties.ThisInternationalStandardconsistsofguidanceandrecommendationsandisnotintendedforcertification,regulatoryorcontractualuse,norasaguidetothe

4、implementationofISO9001.NormativereferenceThefollowingnormativedocumentcontainsprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreementsbasedonthisInt

5、ernationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionofthenormativedocumentindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentreferredtoapplies.MembersofISOandIECmaintainregistersofcurrentlyvalidInternationalStandards.ISO9000:2000,Qualitymana

6、gementsystems-Fundamentalsandvocabulary.TermsanddefinitionsForthepurposesofthisInternationalStandard,thetermsanddefinitionsgiveninISO9000apply.Thefollowingterms,usedinthiseditionofISO9004todescribethesupply-chain,havebeenchangedtoreflectthevocabularycurrentlyused:supplierkorganizationcustomer(intere

7、stedparties)occurs,itcoccurs,itcThroughoutthetextofthisInternationalStandard,wherevertheterm“product”a”service.QualitymanagementsystemManagingsystemsandprocessesLeadingandoperatinganorganizationsuccessfullyrequiresmanagingitinasystematicandvisiblemanner.Successshouldresultfromimplementingandmaintain

8、ingamanagementsystemthatisdeignedtocontinuallyimprovetheeffectivenessandefficiencyoftheorganizationsperformaneebyconsideritheneedsofinterestedparties.Managinganorganizationincludesqualitymanagement,amongothermanagementdisciplines.Topmanagementshouldestablishacustomer-orientedorganizationbydefiningsy

9、stemsandprocessesthatcanbeclearlyunderstood,managedandimprovedineffectivenessawellasefficiency,andbyensuringeffectiveandefficientoperationandcontrolofprocessesandthemeasuresanddatauseddeterminesatisfactoryperformaneeoftheorganization.Examplesofactivitiestoestablishacustomer-orientedorganizationinclu

10、de-definingandpromotingprocessesthatleadtoimprovedorganizationalperformanee,-acquiringandusingprocessdataandinformationonacontinuingbasis,-directingprogresstowardscontinualimprovement,and-usingsuitablemethodstoevaluateprocessimprovement,suchasself-assessmentsandmanagementreview.Examplesofself-assess

11、mentandcontinualimprovementprocessesaregiveninannexesAandBrespectively.ISO9001:2000,Qualitymanagementsystems-RequirementsQualitymanagementsystemGeneralrequirementsTheorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordaneewitht

12、herequirementsofthisInternationalStandard.Theorganizationshallidentifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization,determinethesequeneeandinteractionoftheseprocesses,determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocesses

13、areeffective,ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringotheseprocesses,monitor,measureandanalysetheseprocesses,andimplementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.Theseprocessesshallbemanagedbytheorganizationinacco

14、rdaneewiththerequirementsofthisInternationalStandard.Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitywithrequirements,theorganizationshallensurecontroloversuchprocesses.Controlofsuchoutsourcedprocessesshallbeidentifiedwithinthequalitymanagementsystem.NOTEProcessesneededfor

15、thequalitymanagementsystemreferredtoaboveshouldincludeprocessesformanagementactivities,provisionofresources,productrealizationandmeasurement.DocumentationManagementshoulddefinethedocumentation,includingtherelevantrecords,neededtoestablish,implementandmaintainthequalitymanagementsystemandtosupportand

16、effectiveandefficientoperationoftheorganizationprocesses.Thenatureandextentofthedocumentationshouldsatisfythecontractual,statutoryandregulatoryrequirements,andtheneedsandexpectationsofcustomersandotherinterestedpartiesandshouldbeappropriatetotheorganization.Documentationmaybeinanyformormediumsuitabl

17、efortheneedsoftheorganization.Inordertoprovidedocumentationtosatisfytheneedsandexpectationsofinterestedpartiesmanagementshouldconsider-contractualrequirementsfromthecustomerandotherinterestedparties,-acceptaneeofinternational,national,regionalandindustrysectorstandards,-relevantstatutoryandregulator

18、yrequirements,-decisionsbytheorganization,-decisionsbytheorganization,-sourcesofexternalinformationrelevantforthedevelopmentoftheorganizationcompetencies,and-informationabouttheneedsandexpectationsofinterestedparties.Thegeneration,useandcontrolofdocumentationshouldbeevaluatedwithrespecttotheeffectiv

19、enessandefficiencyoftheorganizationagainstcriteriasuchas-functionality(suchasspeedofprocessing),-userfriendliness,-resourcesneeded,-policiesandobjectives-currentandfuturerequirementsrelatedtomanagingknowledge.-benchmarkingofdocumentationsystems,and-interfacesusedbyorganizationcustomers,suppliersando

20、therinterestedparties.Accesstodocumentationshouldbeensuredforpeopleintheorganizationandtootherinterestedparties,basedontheorganizationscommunicationpolicy.ISO9OO1:2OOO,Qualitymanagementsystems-RequirementsDocumentationrequirementsGeneralThequalitymanagementsystemdocumentationshallincludedocumentedst

21、atementsofaqualitypolicyandqualityobjectives,aqualitymanual,documentedproceduresrequiredbythisInternationalStandard,documentsneededbytheorganizationtoensuretheeffectiveplanning,operationandcontrolofitsprocesses,andrecordsrequiredbythisInternationalStandard.NOTE1Wherethetermdocumentedprocedure”appear

22、swithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintained.NOTE2Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherduetothesizeoforganizationandtypeofactivities,thecomplexityofprocessesandtheirinteraction,andthecomp

23、eteneeofpersonnel.NOTE3Thedocumentationcanbeinanyformortypeofmedium.QualitymanualTheorganizationshallestablishandmaintainaqualitymanualthatincludesthescopeofthequalitymanagementsystem,includingdetailsofandjustificationforanyexclusions,thedocumentedproceduresestablishedforthequalitymanagementsystem,o

24、rreferencetothem,andadescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem.Controlofdocumentstoapprovedocumentsforadequacypriortoissue,toreviewandupdateasnecessaryandre-approvedocuments,toensurethatchangesandthecurrentrevisionstatusofdocumentsareidentified,toensurethatrelevantve

25、rsionsofapplicabledocumentsareavailableatpointsofuse,toensurethatdocumentsremainlegibleandreadilyidentifiable,toensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled,andtopreventtheunintendeduseofobsoletedocuments,andtoapplysuitableidentificationtothemiftheyareretainedoranyp

26、urpose.ControlofrecordsRecordsshallbeestablishedandmaintainedtoprovideevideneeofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagementsystem.Recordsshallremainlegible,readilyidentifiableandretrievable.Adocumentedprocedureshallbeestablishedtodefinethecontrolsneededfortheidentificati

27、on,storage,protection,retentiontimeanddispositionofrecords.UseofqualitymanagementprinciplesToleadandoperateanorganizationsuccessfully,itisnecessarytomanageitinasystematicandvisiblemanner.TheguidaneetomanagementofferedinthisInternationalStandardisbasedoneightqualitymanagementprinciples.Theseprinciple

28、shavebeendevelopedforusebytopmanagementinordertoleadtheorganizationtowardimprovedperformanee.ThesequalitymanagementprinciplesareintegratedinthecontentsofthisInternationalStandardandarelistedbelowCustomerfocusOrganizationsdependontheircustomersandthereforeshouldunderstandcurrentandfuturecustomerneeds

29、,shouldmeetcustomerrequirementsandstrivetoexceedcustomerexpectations.LeadershipLeadersestablishunityofpurposeanddirectionoftheorganization.Theyshouldcreateandmaintaintheinternalenvironmentinwhichpeoplecanbecomefullyinvolvedinachievingtheorganizationsobjectives.InvolvementofpeoplePeopleatalllevelsare

30、theessenceofanorganizationandtheirfullinvolvementenablestheirabilitiestobeusedfortheorganizationsbenefit.ProcessapproachAdesiredresultisachievedmoreefficientlywhenactivitiesandrelatedresourcesaremanagedasaprocess.SystemapproachtomanagementIdentifying,understandingandmanaginginterrelatedprocessesasas

31、ystemcontributestotheorganizationseffectivenessandefficiencyinachievng)bjectives.ContinualimprovementContinualimprovementoftheorganizationsoverallperformanceshouldbeapermanentobjectiveoftheorganization.FactualapproachtodecisionmakingEffectivedecisionsarebasedotheanalysisofdataandinformation.Mutually

32、beneficialsupplierrelationshipsAnorganizationanditssuppliersareinterdependentandamutuallybeneficialrelationshipenhancestheabilityofbothtocreatevalue.Successfuluseoftheeightmanagementprinciplesbyanorganizationwillresultinbenefitstointerestedparties,suchasimprovedmonetaryreturns,thecreationofvalueandi

33、ncreasedstability.ManagementresponsibilityGeneralguidanceIntroductionLeadership,commitmentandtheactiveinvolvementofthetopmanagementareessentialfordevelopingandmaintaininganeffectiveandefficientqualitymanagementsystemtoachievebenefitsforinterestedparties.Toachievethesebenefits,itisnecessarytoestablis

34、h,sustainandincreasecustomersatisfaction.Topmanagementshouldconsideractionssuchasestablishingavision,policiesandstrategicobjectivesconsistentwiththepurposeoftheorganization,leadingtheorganizationbyexample,inordertodeveloptrustwithinitspeople,communicatingorganizationaldirectionandvaluesregardingqual

35、ityandthequalitymanagementsystem,participatinginimprovementprojects,searchingfornewmethods,solutionsandproducts,obtainingfeedbackdirectlyontheeffectivenessandefficiencyofthequalitymanagementsystem,identifyingtheproductrealizationprocessesthatprovideaddedvaluetotheorganization.creatinganenvironmentth

36、atencouragestheinvolvementanddevelopmentofpeople,andprovisionofthestructureandresourcesthatarenecessarytosupporttheorganizationsstrategicplansTopmanagementshouldalsodefinemethodsformeasurementoftheorganizationsperformaneetodeterminewhetherplannedobjectiveshavebeenachieved.Methodsincludefinancialmeas

37、urement,measurementofprocessperformaneethroughouttheorganization,externalmeasurement,suchasbenchmarkingandthird-partyevaluation,assessmentofthesatisfactionofcustomers,peopleintheorganizationandotherinterestedparties,assessmentoftheperceptionsocustomersandotherinterestedpartiesofperformaneeofproducts

38、provided,andmeasurementofothersuccessfactorsidentifiedbymanagement.Informationderivedfromsuchmeasurementsandassessmentsshouldalsobeconsideredasinputtomanagementreviewinordertoensurethatcontinualimprovementofthequalitymanagementsystemisthedriverforperformaneeimprovementoftheorganization.Issuestobecon

39、sideredWhendeveloping,implementingandmanagingtheorganizationqualitymanagementsystem,managementshouldconsiderthequalitymanagementprinciplesoutlinedin4.3.Onthebasisoftheseprinciples,topmanagementshoulddemonstrateleadershipin,andcommitmentto,thefollowingactivities:understandingcurrentandfuturecustomern

40、eedsadexpectations,inadditiontorequirements;promotingpoliciesandobjectivestoincreaseawareness,motivationandinvolvementofpeopleintheorganization;establishingcontinualimprovementasanobjectiveforprocessesoftheorganization;planningforthefutureoftheorganizationandmanagingchange;settingandcommunicatingafr

41、ameworkforachievingthesatisfactionofinterestedparties.Inadditiontosmall-steporongoingcontinualimprovement,topmanagementshouldalsoconsiderbreakthroughchangestoprocessesasawaytoimprovetheorganizationpbrformanee.Duringsuchchanges,managementshouldtakestepstoensurethattheresourcesandcommunicationneededto

42、maintainthefunetionsofthequalitymanagementsystemareprovided.Topmanagementshouldidentifytheorganizationpfoductrealizationprocesses,asthesearedirectlyrelatedtothesuccessoftheorganization.Topmanagementshouldalsoidentifythosesupportprocessesthataffecteithertheeffectivenessandefficiencyoftherealizationpr

43、ocessesortheneedsandexpectationsofinterestedparties.Managementshouldensurethatprocessesoperateasaneffectiveandefficientnetwork.Managementshouldanalyseandoptimizetheinteractionofprocesses,includingbothrealizationprocessesandsupportprocesses.Considerationshouldbegiventoensuringthatthesequeneeandintera

44、ctionofprocessesaredesignedtoachievethedesiredresultseffectivelyandefficiently,ensuringprocessinputs,activitiesandoutputsareclearlydefinedandcontrolled,monitoringinputsadoutputstoverifythatindividualprocessesarelinkedandoperateeffectivelyadefficiently,identifyingandmanagingrisks,andexploitingperform

45、aneeimprovementopportunities,conductingdataanalysistofacilitatecontinualimprovementofprocesses,identifyingprocessownersandgivingthemfullresponsibilityandauthority,-managingeachprocesstoachievetheprocessobjectives,and-theneedsandexpectationsofinterestedparties.ISO9001:2000,Qualitymanagementsystems-Re

46、quirementsManagementresponsibilityManagementcommitmentTopmanagementshallprovideevideneeofitscommitmenttothedevelopmentandimplementationofthequalitymanagementsystemandcontinuallyimprovingitseffectivenessbycommunicatingtotheorganizationtheimportaneeofmeetingcustomeraswellasstatutoryandregulatoryrequir

47、ements,establishingthequalitypolicy,ensuringthatqualityobjectivesareestablished,conductingmanagementreviews,andensuringtheavailabilityofresources.NeedsandexpectationsofinterestedpartiesGeneralEveryorganizationhasinterestedparties,eachpartyhavingneedsandexpectations.Interestedpartiesoforganizationsin

48、cludecustomersandend-users,peopleintheorganization,owners/investors(suchasshareholders,individualsorgroups,includingthepublicsector,thathaveaspecificinterestintheorganization),suppliersandpartners,andsocietyintermsofthecommunityandthepublicaffectedbytheorganizationoritsproducts.NeedsandexpectationsT

49、hesuccessoftheorganizationdependsonunderstandingandsatisfyingthecurrentandfutureneedsandexpectationsofpresentandpotentialcustomersandend-users,aswellasunderstandingandconsideringthoseofotherinterestedparties.Inordertounderstandandmeettheneedsandexpectationsofinterestedparties,anorganizationshouldide

50、ntifyitsinterestedpartiesandmaintainabalaneedresponsetotheirneedsandexpectations,translateidentifiedneedsandexpectationsintorequirements,communicatetherequirementsthroughouttheorganization,andfocusonprocessimprovementtoensurevaluefortheidentifiedinterestedparties.Tosatisfycustomerandend-userneedsand

51、expectations,themanagementofanorganizationshouldunderstandtheneedsandexpectationsofitscustomers,includingthoseofpotentialcustomers,determinekeyproductcharacteristicsforitscustomersandend-users,identifyandassesscompetitioninitsmarket,andidentifymarketopportunities,weaknessesandfuturecompetitiveadvant

52、age.Examplesofcustomerandend-userneedsandexpectations,asrelatedtotheorganizationproducts,includeconformity,dependability,availability,delivery,post-realizationactivities,priceandlife-cyclecosts,productsafety,productliability,andenvironmentalimpact.Theorganizationshouldidentifyitspeoplesneedsandexpec

53、tationsforrecognition,worksatisfaction,apersonaldevelopment.Suchattentionhelpstoensurethattheinvolvementandmotivationofpeopleareasstrongaspossible.Theorganizationshoulddefinefinancialandotherresultsthatsatisfytheidentifiedneedsandexpectationsofownersandinvestors.Managementshouldconsiderthepotentialb

54、enefitsofestablishingpartnershipswithsupplierstotheorganization,inordertocreatevalueforbothparties.Apartnershipshouldbebasedonajoinstrategy,sharingknowledgeaswellasgainsandlosses.Whenestablishingpartnerships,anorganizationshouldidentifykeysuppliers,andotherorganizations,aspotentialpartners,jointlyes

55、tablishaclearunderstandingofcustomersneedsandexpectations,jointlyestablishaclearunderstandingofthepartnersatidnsneedsandexpectsetgoalstosecureopportunitiesforcontinuingpartnerships.Inconsideringitsrelationshipswithsociety,theorganizationshoulddemonstrateresponsibilityforhealthandsafety,considerenvir

56、onmentalimpact,includingconservationofenergyandnaturalresources,identifyapplicablestatutoryandregulatoryrequirements,andidentifythecurrentandpotentialimpactsonsocietyingeneral,andthelocalcommunityinparticular,ofitsproducts,processesandactivities.ISO9001:2000,Qualitymanagementsystems-RequirementsCust

57、omerfocusTopmanagementshallensurethatcustomerrequirementsaredeterminedandaremetwiththeaimofenhancingcustomersatisfaction.StatutoryandregulatoryrequirementsManagementshouldensurethattheorganizationhasknowledgeeofthestatutoryandregulatoryrequirementsthatapplytoitsproducts,processesandactivitiesandshou

58、ldineludesuchrequirementsaspartofthequalitymanagementsystem.Considerationshouldalsobegiventothepromotionofethical,effectiveandefficientcomplianeewithcurrentandprospectiverequirements,thebenefitstointerestedpartiesfromexceedingcomplianee,andtheroleoftheorganizationintheprotectionofcommunityinterests.

59、QualitypolicyTopmanagementshouldusethequalitypolicyasameansofleadingtheorganizationtowardimprovementofitsperformanee.Anorganizationquastypolicyshouldbeanequalandconsistentpartoftheorganizationovesallpoliciesandstrategy.Inestablishingthequalitypolicy,topmanagementshouldconsiderthelevelandtypeoffuture

60、improvementneededfortheorganizationtobesuccessful,theexpectedordesireddegreeofcustomersatisfaction,thedevelopmentofpeopleintheorganization,theneedsandexpectationsofotherinterestedparties,theresourcesneededtogobeyondISO9001requirements,andthepotentialcontributionsofsuppliersandpartners.Thequalitypoli