英文版ISO90012000

[e-mail]:::222000000000TTThhhiiirrrdddeeedddiiitttiiiooonnn222000000000---111222---111555QQQuuuaaallliiitttyyymmmaaannnaaagggeeemmmeeennntttsssyyysssttteeemmmsss---RRReeeqqquuuiiirrreeemmmeeennntttsssRRReeefffeeerrreeennnccceeennnuuummmbbbeeerrrIIISSSOOO999000000111:::222000000000(((EEE)))Contents1.Scope1.1General1.2Application2.Normativereference3.Termanddefinitions4.Qualitymanagementsystem4.1Generalrequirements4.2Documentationrequirements5.Managementresponsibility5.1Managementcommitment5.2Customerfocus5.3Qualitypolicy5.4Planning5.5Responsibility,authorityandcommunication5.6Managementreview6.Resourcemanagement6.1Provisionofresources6.2Humanresources6.3Infrastructure6.4Workenvironment7.Productrealization7.1Planningofproductrealization7.2Customer-relatedprocesses7.3Designanddevelopment7.4Purchasing7.5Productionandserviceprovision7.6Controlofmonitoringandmeasuringdevices8.Measurement,analysisandimprovement8.1General8.2Monitoringandmeasurement8.3Controlofnonconformingproduct8.4Analysisofdata8.5ImprovementAnnexesACorrespondencebetweenISO9001:2000andISO14001:1996BCorrespondencebetweenISO9001:2000andISO9001:[e-mail](theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedourthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofeletrotechnicalstandardization.InternationalStandardsadoptedbytheaccordancewiththerulesgivenintheISO/IECDirectives,Part3.DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirculatedtothememberbodiesforvoting.PublicationasanInternationalStandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.AttentionisdrawntothepossibilitythatsomeoftheelementsofthisInternationalStandardmaybethesubjectofpatentrights.ISOshallnotbeheldresponsibleforidentifyinganyorallsuchpatentrights.InternationalStandardISO9001waspreparedbyTechnicalCommitteeISO/TC176,Qualitymanagementandqualityassurance,SubcommitteeSC2,Qualitysystems.ThisthirdeditionofISO9001cancelsandreplacesthesecondedition(ISO9001:1994)togetherwithISO9002:1994andISO9003:1994.Itconstitutesatechnicalrevisionofthesedocuments.ThoseorganizationswhichhaveusedISO9002:1994andISO9003:1994inthepastmayusethisInternationalStandardbyexcludingcertainrequirementsinaccordancewith1.2.ThetitleofISO9001hasbeenrevisedinthiseditionandnolongerincludestheterm“Qualityassurance”.ThisreflectsthefactthatthequalitymanagementsystemrequirementsspecifiedinthiseditionofISO9001,inadditiontoqualityassuranceofproduct,alsoaimtoenhancecustomersatisfaction.AnnexesAandBofth[e-mail]’squalitymanagementsystemisinfluencedbyvaryingneeds,particularobjectives,theproductsprovided,theprocessesemployedandthesizeandstructureoftheorganization.ItisnottheintentofthisInternationalStandardtoimplyuniformityinthestructureofqualitymanagementsystemsoruniformityofdocumentation.ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandardarecomplementarytorequirementsforproducts.Informationmarked“NOTE”isforguidanceinunderstandingorclarifyingtheassociatedrequirement.ThisInternationalStandardcanbeusedbyininternalandexternalparties,includingcertificationbodies,toassessthedevelopmentofthisInternationalStandard.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)continualimprovementofprocessesbasedo