ISO 90002000(英文版)

ANSI/ISO/ASQQ9001-2000AMERICANNATIONALSTANDARDQualitymanagementsystems—RequirementsApprovedasaAmericanNationalStandardby:AmericanSocietyforQualityAnAmericanNationalStandardApprovedonDecember13,2000AmericanNationalStandards:AnAmericanNationalStandardimpliesaconsensusofthosesubstantiallyconcernedwithitsscopeandprovisions.AnAmericanNationalStandardisintendedasaguidetoaidthemanufacturer,theconsumer,andthegeneralpublic.TheexistenceofanAmericanNationalStandarddoesnotinanyrespectprecludeanyone,whetherheorshehasapprovedthestandardornot,frommanufacturing,purchasing,orusingproducts,processes,orproceduresnotconformingtothestandard.AmericanNationalStandardsaresubjecttoperiodicreviewandusersarecautionedtoobtainthelatestedition.CautionNotice:ThisAmericanNationalStandardmayberevisedorwithdrawnatanytime.TheproceduresoftheAmericanNationalStandardsInstituterequirethatactionbetakentoreaffirm,revise,orwithdrawthisstandardnolaterthanfiveyearsfromthedateofpublication.PurchasersofAmericanNationalStandardsmayreceivecurrentinformationonallstandardsbycallingorwritingtheAmericanNationalStandardsInstitute.vANSI/ISO/ASQ09001-2000ContentsPage1Scope11.1General11.2Application12Normativereference13Termsanddefinitions14Qualitymanagementsystem24.1Generalrequirements24.2Documentationrequirements25Managementresponsibility35.1Managementcommitment35.2Customerfocus45.3Qualitypolicy45.4Planning45.5Responsibility,authorityandcommunication45.6Managementreview56Resourcemanagement56.1Provisionofresources56.2Humanresources66.3Infrastructure66.4Workenvironment67Productrealization67.1Planningofproductrealization67.2Customer-relatedprocesses77.3Designanddevelopment87.4Purchasing97.5Productionandserviceprovision107.6Controlofmonitoringandmeasuringdevices118Measurement,analysisandimprovement118.1General118.2Monitoringandmeasurement118.3Controlofnonconformingproduct128.4Analysisofdata138.5Improvement13AnnexesACorrespondencebetweenISO9001:2000andISO14001:199615BCorrespondencebetweenISO9001:2000andISO9001:199419Bibliography23ANSI/ISO/ASQQ9001-2000ixIntroduction0.1GeneralTheadoptionofaqualitymanagementsystemshouldbeastrategicdecisionofanorganization.Thedesignandimplementationofanorganization’squalitymanagementsystemisinfluencedbyvaryingneeds,particularobjectives,theproductsprovided,theprocessesemployedandthesizeandstructureoftheorganization.ItisnottheintentofthisInternationalStandardtoimplyuniformityinthestructureofqualitymanagementsystemsoruniformityofdocumentation.ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandardarecomplementarytorequirementsforproducts.Informationmarked“NOTE”isforguidanceinunderstandingorclarifyingtheassociatedrequirement.ThisInternationalStandardcanbeusedbyinternalandexternalparties,Includingcertificationbodies,toassesstheorganization’sabilitytomeetcustomer,regulatoryandtheorganization’sownrequirements.ThequalitymanagementprinciplesstatedinISO9000andISO9004havebeentakenintoconsiderationduringthedevelopmentofthisInternationalStandard.0.2ProcessapproachThisInternationalStandardpromotestheadoptionofaprocessapproachwhendeveloping,implementingandimprovingtheeffectivenessofaqualitymanagementsystem,toenhancecustomersatisfactionbymeetingcustomerrequirements.Foranorganizationtofunctioneffectively,ithastoidentifyandmanagenumerouslinkedactivities.Anactivityusingresources,andmanagedinordertoenablethetransformationofinputsIntooutputs,canbeconsideredasaprocess.Oftentheoutputfromoneprocessdirectlyformstheinputtothenext.Theapplicationofasystemofprocesseswithinanorganization,togetherwiththeidentificationandinteractionsoftheseprocesses,andtheirmanagement,canbereferredtoasthe“processapproach”.Anadvantageoftheprocessapproachistheongoingcontrolthatitprovidesoverthelinkagebetweentheindividualprocesseswithinthesystemofprocesses,aswellasovertheircombinationandinteraction.Whenusedwithinaqualitymanagementsystem,suchanapproachemphasizestheimportanceofa)understandingandmeetingrequirements,b)theneedtoconsiderprocessesintermsofaddedvalue,C)obtainingresultsofprocessperformanceandeffectiveness,andd)continualimprovementofprocessesbasedonobjectivemeasurement.Themodelofaprocess-basedqualitymanagementsystemshowninFigure1illustratestheprocesslinkagespresentedinclauses4to8.Thisillustrationshowsthatcustomersplayasignificantroleindefiningrequirementsasinputs.Monitoringofcustomersatisfactionrequirestheevaluationofinformationrelatingtocustomerperceptionastowhethertheorganizationhasmetthecustomerrequirements.ThemodelshowninFigure1coversalltherequirementsofthisInternationalStandard,butdoesnotshowprocessesatadetailedlevel.xANSI/ISO/ASQQ9001-2000NOTEInaddition,themethodologyknownas“Plan-Do-Check-Act”(PDCA)canbeappliedtoallprocesses.PDCAcanbebrieflydescribedasfollows.Plan:establishtheobjectivesandprocessesnecessarytodeliverresultsinaccordancewithcustomerrequirementsandtheorganization’spolicies.Do:implementtheprocesses.Check:monitorandmeasureprocessesandproductagainstpolicies,objectivesandrequirementsfortheproductandreporttheresults.Act:takeactionstocontinuallyim