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Qualitymanagementsystems—RequirementsSystemèsdemanagementdelaqualité—ExigencesThisdocumentiscirculatedasreceivedfromthecommitteesecretariat.ISO/CENPARALLELPROISO/CENPARALLELPROCESSINGISO/DIS9001ISO/TC176/SC2Secretariat:BSIVotingbeginson:2025-08-27Votingterminateson:2025-11-19THISDOCUMENTISADRAFTCIRCLATELFORCOMMENTSANDAPPROVAL.ITISTHEREFORESUBJECTTOCHANGEANDMAYNOTBEREFERREDTOASANNTERNATIONAL.STANDARDUNTILPUBLISHEDASSUCH.INADDITIONTOTHEIREVALUATIONASBEINGACCEPTABLEFORINDUSTRIAL,TECHNOLOGICAL.COMMERCIALANDUSERPURPOSES,DRAFTINTERNATIONALSTANDARDSMAYONOCCASIONHAVETOBECONSIDEREDINTHELIGHTOFTHEIRPOTENTIALTOBECOMESTANDARDSTOWHICHREFERENCEMAYBEMADEINNATIONALREGULATIONS.RECIPIENTSOFTHISDRAFTAREINVITEDTOSUBMIT,WITHTHEIRCOMMENTS,NOTIFICATIONOFANYRELEVANTPATENTRIGHTSOFWHICHTHEYAREAWAREANDTOPROVIDESUPPORTINGDOCUMENTATION.ISO2025-AllrightsreseAllrightsreserved.Unlessotherwisespecified,orrequiredinthecontextofitsimplementation,nopartofthispublicationmaybereproducedorutilizedotherwiseinanyformorbyanymeans,electronicormechanical,includingphotocoontheinternetoranintranet,withoutpriorwrittenpermission.PermirequestedfromeitherISOattheaddressbeloworISO'smemberbodyinth保留所有权利。除非另有规定或在其实施过程中要求,得以任何形式或通过任何电子或机械方式(包括影印)或本出版物的任何部分进行复制或利用。可以向以CP401·Ch.deBlandonnet8Email:copyright@iso0.2Qualitymanagementprinciples0.2质量管理原则4Contextoftheorganizati4.2Understandingtheneedsand4.3Determiningthescopeofthequalityma6.3Planningofchanges6.3变更的策划7.1.4Environmentfortheoperati7.5.3Controlofdocumente8.2.3Reviewoftherequirementsfo8.3Designanddevelopment8.5.1Controlofproductionan9Performanceevaluation9绩效评价AnnexA(informative)Clarificationofstructure,teForeword前言bodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjeccommitteehasbeenestablishedhastherighttoberepresentedonthatcommittee.Internaorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthewISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardiTheproceduresusedtodevelopthisdocumentandthoseintendedforitsfurthdescribedintheISO/IECDirectives,Part1.Inparticular,thdifferenttypesofISOdocumentsshouldbenoted.ThisdocumentwasdraftedinaccordancewiththeeditorialrulesoftheISO/IECDirectives,Part2(see/directives).注意,不同类型的ISO文件需要不同的批准准则。本文件是根据ISO/IEC指南第2部分ISOdrawsattentiontothepossibilitytha(a)patent(s).ISOtakesnopositionconcerningtheevidence,validityorapplicabilityofanyclaimpatentrightsinrespectthereof.Asofthedateofpublicationofthisdocument,ISOhadnotreceivednoticeof(a)patent(s)whichmayberequiredtoimplementthisdocument.However,implementersarecautionedthatthismaynotrepresentthelatestinformation,whichmaybeobtainedfromthepadatabaseavailableat/patents.ISOshallnotbeheldresponsibleforidentifyinganyorall的专利通知。然而,提醒实施者注意,这可能不是最新信息,最新信息可从/pateAnytradenameusedinthisdocumentisinformationgivenfortheconvenienceofusersanddconstituteanendorsForanexplanationofthevoluntarynatureofstandards,themeaningofISOspecifictermsandexpressionsrelatedtoconformityassessment,aswellasinformationWorldTradeOrganization(WTO)principlesintheTechnicalBarrierstoT/iso/foreword.html.(WTO)《技术性贸易壁垒协定》(TBT)原则的信息,ThisdocumentwaspreparedbyTechnicalCommitteeISO/TC17本文件由ISO/TC176技术委员会“质量管理和质量保证”Introduction引言TheadoptionofaqualitymanagementsystemisastrategictoimproveitsoverallperformanceandprovideasoundbasisforsustainablThepotentialbenefitstoanorganizationofimplementingaqualitymanagemerequirementsinthisdocumentare:a)theabilitytoconsistenstatutoryandregulaThisdocumentcanbeusedbyinternalandexternalpItisnottheintentofthisdocumenttoimplytheneedfor:——uniformityinthe——alignmentofdocumentationtotheclausestruc——theuseofthespecificterminologyofthisdocumentwThequalitymanagementsystemrequirementsspecifiedinthisdocumentarerequirementsforproductsandservice本文件中规定的质量管理体系要求是对产品和服务要Consistentlymeetingrequirementsandaddressingfutureneedsandexpectationsofcustomersandrelevantinterestedpartiesposesachallengefororganizationsinaenvironment.Toachievethisobjective,theorganizationcanadoptvariousformsofimadditiontocontinualimprovement,suchasbreakthroughchange,innovationandr在日益动态和复杂的环境中,持续满足要求并应对顾客及相关方的未来需求和期望对组了挑战。为实现此目标,组织除了持续改进外,还可以采取各种形式的改进,如突破AnnexAprovidesinformationandclarificationsthatcansupportunderstandingoftherequirementsofthisdocument.ThisisaninformativeannexanddoesnotcontaForguidanceontheapplicationofallclauThisdocumentisbasedonthequalitymanagementdescriptionsincludeastatementofeachprinciple,arationaleofwhytheprincipleisimportantfortheorganization,someexamplesofbenefitsassociatedwiththeprincipleandexamplesoftypicalactionstoimprovetheorganization'sperformancewhenapplyingtheprincipl——engagementofpeople;Thisdocumentpromotestheadoptionofaprocessapproachwhenestablishing,implementingandimprovingtheeffectivenessomeetingcustomerrequirements.SpecificrequirementsconsideredessentialtotheadoptionofaprocessapproachareincludedinUnderstandingandmanaginginterrelatedprocessesasasystemcontributestotheorgeffectivenessandefficiencyinachievingitsintendedresults.Thiscontroltheinterrelationshipsandinterdependenciesamongtheprocessesofthesystem,sothattheoverallperformanceoftheorganizationcanbeenhanced.Theprocessapproachinvolvesthesystematicdeterminationandmanagementofprocesses,andtheirdirectionoftheorganization.ManagementoftheprocessesandthesystemasawholecanbeachievedusingthePDCAcycle(see0.3.2)withanoverallfocusonrisk-opportunity-basedthinking(seeA.6.1.3)aimedattakingadvantageofopportunitiesandpreventingundesirableresults.过程方法涉及对过程及其相互作用的系统性确定和管理,以便根据组织的质量方针利用机遇和预防不良结果的基于风险的思维(见A.6.1.2)和基于机遇的思维(见A.6.1.3)。Theapplicationoftheprocessappb)theconsiderationofprocessesintermsofaddedvalue;d)improvementofprocessesbasedontheresultsofevaluationofdataandFigure1givesaschematicrepresentationofanyprocessandshowstmonitoringandmeasuringcheckpoints,whicharenecessaryforcontrol,arespeciandwillvarydependingontheprocessstepsandrelatedriFigure1—SchematicrepresentationoftheelementsofasingleprocessThePDCAcyclecanbeappliedtoallprocessesandtotFigure2illustrateshowClause4toClause10ofthisdocumePDCA循环可以应用于所有过程以及整个质量管理体系。图2说明了本文件第4Figure2—Representationofthestructureofthisdocumenti——Plan:establishtheobjectivesofthesystemanditsprocesses,andtheresourcesneededtodeliverresultsinaccordancewithcustomers'requirementsandtheorganization'spolicies,anddeterm——Check:monitorand(whereapplicable)measureprocessesandtheresultingproduagainstpolicies,objectives,requirementsandplannedactivities,andreportthe0.4RelationshipwithotherThisdocumentenablesanorganizationtousetheprocessapproach,coupledwithrisk-basedthinkingandopportunity-basedwiththerequirementsofothermanagementsystemstandards.——ISO/CD9000Qualitymanagementsystems—Fundamentalsandvocabubackgroundfortheproperunderstandingandimplementationofthisdocument;——ISO9004[2]Qualitymanagement-Qualityofanorganization-Guidancetoachievesustainedsuccessprovidesguidancefororganizationsthatchoosetoprogressbeyondthereqofthisdocument.——ISO/TS9002[1]Qualitymanagementsystems-Guidelinesfortheapplicatio9001providesimplementationguidThisdocumentdoesnotincluderequirementsspecifictoothermanagenvironmentalmanagement,occupationalhealthandsafetymanagement,orfinancialmanag本文件不包括针对其他管理体系的特定要求,例如环境管理、职业健康安全Sector-specificISOqualitymanagementsystemstandardsbasedontherequirementsofthisdocumenthavebeendeveloped.Someofthesestandardsspecifyadditionalqualitymanagementsystrequirements,whileothersarelimitedtoprovidingguidancetotheapplicationofthisdocumentwithintheparticularsector.量管理体系要求,而另一些则仅限于在特定行业内为本文NOTESeehttps:///management-system-standards-list.html[3]foralistofallmanagementISO2025-Allrightsrese1DRAFTInternationalStandardISO/DIS9001:2025(en)Qualitymanagementsystemapplicablestatutoryandregulatoryrequirementb)aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,incprocessesforimprovementofthesystemAlltherequirementsofthisdocuNOTE1Inthisdocument,theintendedfor,orrequiredby,aNOTE2Statutoryandregulatoryrequiremeconstitutesrequirementsofthisdocument.Fordatedreferences,onlytheeditioncitedapplundatedreferences,thelatesteditionofthereferenceddocument(includin下列文件中的条款通过在本文件中的引用而构成本文件的条款。凡是注日期的引用日期版本适用于本文件。凡是不注日期的引用文件,其最新版本(包括所有的修改ISO/CD9000,Qualitymanagementsystems—FundISO2025-Allrightsrese2Forthepurposesofthisdocument,thetermsISOandIECmaintainterminologydatabasesforuseinstandardiISOOnlinebrowsingplatform:availableat/obpISO在线浏览平台:https://www.IECElectropedia:availableatIEC电工百科:https://www.elpersonorgroupofpeoplethathasitsownfunctionswithresponsibilities,authoritiesandrelationshipscorporation,firm,enterprise,authority,partnewhetherincorporatedornot伙企业、慈善机构或社团,或上述组织的部分或Note2toentry:Iftheorganizationispartofalargerentity,theterm“organization”refersonlytothepartofthelargerentitythatiswithinthescopeofthequalitymanagementsystem(3.4.1).personororganization(3.1)thatcanaffect,bepartnersorsocietythatcanincludecompetitorsoISO2025-Allrightsrese3personorgroupofpeoplewhodirectsandcontrolsanorganization(3.1)atthehighestNote2toentry:Ifthescopeofthemanagementsystem(3.4)coversoorganization,thentopmanagementreferstothosewhodirectandcontrolthatpartoftheorganization.setofinterrelatedorinteractingelementsofanorganization(3.1)toestablishpolicies(objectives(3.6),aswellasprocesses(3.8)toachievethoseNote2toentry:Themanagementsystemelementsincludetheorganization'responsibilities,planningandoperation.Note3toentry:ThemanagementsystemelementscanincNote4toentry:Anorganiandidentifiedfunctionsoftheorganization,specificandidentifiedsectionsoftheorganizatioormorefunctionsacrossagroupoforganizaISO2025-Allrightsrese4qualitymanagementsystpartofamanagementsystem(3.intentionsanddirectionofanorgNote1toentry:Thequalitypolicyisgenerallyconsistentwiththeoverallpolic(3.1),canbealignedwiththeorganization'svisionandmissionandpsettingofqualityobjectives(3.6.1).Note2toentry:QualitymanagementprinciplespresentedinISO/CD9000canformabestablishmentofaqualitypolicy.Note2toentry:Objectivescanrelatetodifferentenvironment).Theycanbe,forexample,organization-wideorspprocess(3.8).purpose,asanoperationalcriterion,asaqualityobjective(3.6.1)orbytheuseofothersimilarmeaning(e.g.aim,goal,ortNote4toentry:InthecontextofqualitymISO2025-Allrightsrese5setbytheorganization(3.1),consistentwiththequalitypolicy(3.5.Note2toentry:QualityobjectivesaregenerallyspecifiedforrelevantNote2toentry:Uncertaintyisthestate,evenpartial,ofdeficiencyofinformationrunderstandingorknowledgeofanevent,itsconsequence,orlikelihood.combinationofthese.ote4toentry:RiskisoftenexpressedintermsofacombinationofthectNote5toentry:Theword"risk"issometimesusedwhenthereisthepsetofinterrelatedorinteractingaNote1toentry:WhetISO2025-Allrightsrese6thecontextofthereference.Note2toentry:InputstoaprocesaregenerallytheinputsNote3toentry:TwocontrolledconditionstoensurethatintendedresultscanNote5toentry:Aprocesswheretheconformity(3.15)oftheresultingoutputcannotbereadilyoreconomicallyvalidatedisfrequentlyreferredtoasa"specialprocess".informationrequiredtobecoNote2toentry:Documente——evidenceofresultsachieved(reISO2025-Allrightsrese7Note2toentry:Performancecanrelatetomasystemsororganizations(3.recurringactivitytoenhanceperformance(3.11)Note1toentry:"Generallyimplied"meansthatit(3.1)andinterestedparty(3.2)thattheneedorexpectationunderconsNote2toentry:AspecifiedrNote3toentry:Aqualifiercanbeusedtodenoteaspecifictypeofrequirement,e.g.produrequirement,servicerequirement,qualitymanagementrequirement,customerrequirement,qualityrequirement.Note4toentry:Requiritself.ISO2025-Allrightsrese8"compliance"issynonymousbnon-fulfilmentofarequiractiontoeliminatetheNote2toentry:CorrectiveactionistakentopreventrecurrencewhereaspreventiveactionisdeterminetheextenttowhichtheauditcriteriNote1toentry:Anauditcanbeparty),anditcanbeacombinedaudit(combiningtwoormoredisciplines).Note2toentry:AninternalaudISO2025-Allrightsrese9Note4toentry:Thefundamentalelementsofanauditincludethedeterminationoftheconformity(3.15)ofanobjectaccordingtoaprocedurecarriedoutbypeopleselectedtoeobjectivityoftheauditprocess.Note5toentry:Internalauditsareconductedformanagementcanformthebasisforanorganization'sdeclarationofconformity.Independencecanbedemonstratedbythefreedomfromresponsibilityfortheactivitybeingaudited.rganization,suchascustomers,orbyotherpersonsontheirdbyexternal,independentauditingorganizationssuchasthoseprovidingcertification/registrationofconformityorgovernmentalagNote7toentry:AnauditcanalsoNote1toentry:AccordingtoISO3534-determiningthestatusofasystem,aprocess(3.8)oNote2toentry:MonitoringcanalsodeterminethestatusofaproductorasISO2025-AllrightsreseNote3toentry:Monitoringisgenerallyadeterminationofthestatusofanobjedifferentstagesoratdi4Contextoftheorganization组织环境strategicdirectionandthataffectitsabilitytoachievetheintendedresult(s)ofitsquNOTE2Understandingtheexternalcontextcanbefacilitatedbyconsideringlegal,technological,competitive,market,cultural,political,social,economicandenvironmentalissuesinternational,national,re注2:通过考虑法律、技术、竞争、市场、文化、政治、NOTE3Understandingtheinternalcontextcanbefacilitatedbyconsideringissuesrelateorganization'sstrategicdirection,values,culture,resources,knowledgeandper4.2Understandingtheneedsandexpectationsofinterestedb)therelevantrequirementsoftheseISO2025-Allrightsresec)whichoftheserequirementswil4.3DeterminingthescopeofthequTheorganizationshalldeterminetheThescopeshallstatethetypesofproductsandservicescovered,andprovidejustificationrequirementofthisdocumentthattheorganizationdeterminesisnotapplicabletoitsqualitymanagementsystem.determinedscopeofitsqualitymanagementsysteConformitytothisdocumentcanonlybeclaimediftherequirementsdeterminedasnotbeingapplicabledonotaffecttheorganization'sabilityorresponsibilitytoensuretproductsandservicesandtheenhancementofcustomersatisfaction.ISO2025-Allrightsrese4.4.1Theorganizationshallestabqualitymanagementsystem,includingtheprocessesneededandtheiaccordancewiththerequirementsofthisdocument.组织应根据本文件的要求,建立、实施、保持和持续改进质量管理体系,包括所Theorganizationshalldeterminetheprocessesneededforthequalitymanapplicationthroughouttheorganization,anb)determinethesequenceandinterc)determineandapplythecriteriaandmethods(includingmonitoring,measuremeperformanceindicators)neededtoensuretheeffectiveoperationandcontroloftheseprocesses;f)addresstherisksandg)evaluatetheseprocessesandimplementanychangesneededtoensurethatthese评价这些过程并实施任何必要的变更,以确保这些过程实现其预期a)tosupporttheoperatb)asevidencethattheprocessesareISO2025-Allrightsresea)ensuringthatthequalitypolicyandqualityobjectivesareestablistrategicdirectionoftheorganization;b)ensuringtheintegrationofthequalitymanagementsystemd)communicatingtheimportanceofeffectivequalitymanagementandofconformingtothemanagementsystemrequirements;f)directingandsupportingpersonsh)supportingotherrelevantrolestodemonstratetheij)promotingtheuseoftheprocessapproachak)takingaccountabilityforthNOTE1Referenceto"business"inthisdocumentcanbeinthatarecoretothepurposesoftheorganization'sexistence.ISO2025-AllrightsreseNOTE2Anorganization'squalitycultureandethicalbehaviourarerefleb)therisksandopportunitiesthatcanaffectctoenhancecustomersatisfactionaredeterminedandaa)isappropriatetod)includesacommitmenttocontine)takesintoaccountthecoISO2025-Allrightsresecommunicatedandunderstoodwithintheorganizaa)ensuringthatthequalitymanagb)reportingontheperformanceoff)ensuringthattheintegrityoftheqtothequalitymanagementsystemareplannedandWhenplanningforthequalitymanagementsystem,theorganizationtoin4.1andtherequirementsreferredtoin4.2anddeterminetherisksanbeaddressedto:ISO2025-AllrightsreseTheorganizationshalldetermine,analyse,andevaluabilitytocontinuallyandconsistentlyprovideconformingproductsandse2)evaluatetheeffectActionstakentoaddressrisksshallbeproportionatetothepotentiaeliminatingtherisksource,changingthelikelihoodorconsequences,sharingtherisk,obyinformeddecision.注2:应对风险的措施可包括:规避风险、为寻求机遇ISO2025-Allrightsrese6.1.3ActionstoaddressopportunitieTheorganizationshalldetermine,analyse,andevaluaonitsabilitytocontinuallyandconsistentlyprovidecon2)evaluatetheeffectActionstakentoaddressopportunitiesshallbeproportionatetothepotentialimpactoncustomersatisfactionandtheconformityofproductsandservices.NOTEActionstoaddressopportunitiescanincludeadoptingnewpractices,launchingnewproducreatingnewpartnerships,leveragingnewtechnologies,implementinginitiativesandotheractionstoaddressthecurrentandchangingneedsandexpectationsofitscustomersandotherrelevantinteresparties.注:应对机遇的措施可包括:采用新实践、推出新产品、建立新伙伴关系、利用新技ISO2025-Allrightsreseh)berelevanttoconformityofproductsandservicesandtoenhancementofcustom6.2.2WhenplanninghowtoachiWhentheorganizationdeterminestheneedforchangestothequalitymanagementchangesshallbecarriedoutina)thepurposeofthechangesISO2025-Allrightsreseb)theintegrityofthequalitymanad)theallocationorrealf)communicationoftg)howtoreviewtheresultTheorganizationshalldeterimplementation,maintenanceandcontinualimprovementofthequalitymanagementsystem.Theorganizationshalldetermineandprovidethepersonsnecessaryfortheeffofitsqualitymanagementsystemandfortheoperationandcontrolofitsprocesses.fitsprocessesandtoachieveconformityofproductsandservices.NOTEForalltypesofwork(e.g.onsite,remoteoraISO2025-AllrightsreseTheorganizationshallditsprocessesandtoachieveconformityofproductsandservices.NOTEAsuitableenvironmentcanincludeacombinationoffactors,whichcandifferdependingontheproductsandservicesprovided.Relevantfactorscaninclude:b)psychological(e.g.7.1.5MonitoringandmeasuringresourceTheorganizationshalldetermineandprovidetheresourcesneededtoensurevalidandrewhenmonitoringormeasuringisusedtoverifytheconformityofproductsandservicestoa)aresuitableforthespecificISO2025-AllrightsreseAppropriatedocumentedinformationshallbeavailableasevidenceoffitnessforpurposeofthemonitoringandmeasurementresource应提供适当的形成文件的信息,作为监视和测量资源适用其目的Traceabilityofmeasurementresult测量结果的可追溯性Whentraceabilityofmeasurementresultsisarequirement,orisconsideredbytheorganizationtobeanessentialpartofprovidingconfidenceinthevalidityofmeasurementresults,measuringequipmenta)calibratedorverified,orboth,atspecifiedintervals,orpriortouse,againsttraceabletointernationalornationalmeasurementstandards;whennosuchstandardsexist,thebausedforcalibrationorverificationshallbeavailableasdocumentedinfWhenmeasuringequipmentisfoundtobeunfitforitsintendedpurpose,theorgandeterminewhetherthevalidityofpreviousmeasurementresultshasbeenadverselyaffectedandshall7.1.6OrganizationalkTheorganizationshalldeterminetheknowledgenecesachievetheintendedresultsofitsqualitymanagementsystem.Whenaddressingchangingneedsandtrends,theorganizationshallconsdeterminehowtoacquireoraccessanynecessaryadditionalknowledgeandrequiredupNOTESourcesoforganizationalknowledgecaninclude:experience-basedknowledge;lessonsISO2025-Allrightsreselearnedfromfailuresandsuccessfulactivities;experience;theresultsofimprovementsinprocesses,productsandservices;learnexternalproviders;standards;researchpapers;conferences;intellectuala)determinethenecessamanagementsystemperformance;b)ensurethatthesepersonsarecompetentonthebasisAppropriatedocumentedinfoNOTEApplicableactionscaninclude,forexample,theprovisionoftrainingto,thementoringof,orthereassignmentofcurrentlyemployedpersons;orthehiringorcontractingofcompetentpersons.b)theircontributiontotheeffectivenessofthequalitymanagementsystem,includingthebenefitsofc)theimplicationsofnotISO2025-AllrightsreseTheorganizationshalldeterminetheinternalandexternalcommunicatioondeterminedbytheorganizationasbeingnecessaryfortheeffectifthequalitymanagementsysNOTETheextentofdocumentedinformationforaqualitymanagement——thesizeoforganizationanditstypeofactivities,processes,productsandservice——thecomplexityofprocessesandtheirinteractions;——thecompetenceofpersons.ISO2025-Allrightsrese7.5.2Creatingandupdatingdocumentedinformation创建和7.5.3Controlofdocumentedinformation对形成文件的信息的控制Documentedinformationdocumentshallbecontrob)itisadequatelyprotected(e.g.fromlosForthecontrolofdocumentedinformati为控制形成文件的信息,组织应针对以下活动采b)storageandpreservation,inclDocumentedinformationofexternalorigindeterminedbytheorganizationtobenecessaryfortheplanningandoperationofthequalitymanagementsystemshallbeidentifiedasapprcontrolled.组织确定的为策划和运行质量管理体系所必需的外来形成文件的信息,应得到适当识别和控制。DocumentedinformationavailableasevidenceofcISO2025-AllrightsreseorthepermissionandauthoritytoviewandchaTheorganizationshallplan,implementandcontroltheprocessesneededtomeetreproductsandservices,andtoimplementtheactionsb)implementingcontrolofthec)establishingcriteriafortheaDocumentedinformationshallbeavailabletotheprocesseshavebeencarriedoutasTheorganizationshallcontrolplannedchangesandreviewtheconsequencesofunintendedchanges,takingactiontomitigateanyadverseeffects,asntothequalitymanagement-systemarecontrolled(SeeDocumentedinformationshallbeavailabletotheextentnecessarytodemonstratetheconformityofISO2025-Allrightsresee)informationrelatedtocproductsorservicesprNOTECustomercommunicationcanincludedirectcontactsthroughmeetings,electrondocumentexchangeorindirectlythroughwebsitecontent,publications,socialmedia,refrequentlyaskedquestions,andtra8.2.2DeterminingtherequirementsforproductsandseWhendeterminingtherequirementsfortheproductorganizationshallens8.2.3Reviewoftherequirementsforproductsandservices评审产品和服务的要求TheorganizationshallensurethatithastheabilitytomeetthesupplyproductsandseISO2025-Allrightsresea)requirementsspecifiedbythecustomer,includingtherequirementsfordeliveryandpost-delactivitieswhenapplic顾客规定的要求,适用时包括对交付及交付后活动b)requirementsnotstatTheorganizationshal组织应确保与以前规定不一致的合同或订单要customerdoesnotprovideadocumentedstatementoftheirrequirNOTEInsomesituations,sucthereviewcancoverrelevantproductinformation,suchaswebsitesorcatalDocumentedinformationshallbeavailableasapplicable,asevidena)theresultsofthere8.2.4ChangestorequirementsforproductsandWhenrequirementsforproductsandservicesarechanged,theorganizationsh当产品和服务的要求发生变更时,组织应确保相关的形ISO2025-Allrightsrese8.3DesignanddevelTheorganizationshallestablish,implementandmaintainaappropriatetoensurethesubsequentprovisionofproductsandservices.NOTEThedesignanddefeedback,allowingforflexibilitythroughoutth注:设计和开发过程可包括评审、验证、确认和反馈的循环,从而在整个设计和开发8.3.2Designanddevelopmenta)nature,durationandb)requiredprocessstae)internalandexternalresourceneedsg)needforinvolvementofcustomersandh)requirementsforsubsequentprovisi)levelofcontrolexpectedforthedesignanddevelopmentprocessbycustomersandotherrelevj)documentedinformationneededasevidencethatdeISO2025-Allrightsrese作为设计和开发要求已得到满足的证据所需的形成文8.3.3DesignanddevelopmenTheorganizationshalldeterminetherequirementsessentialforthespecifictypesofproservicestobedesignedanddeveloped.Theorganizationd)standardsorcodesofpe)potentialconsequencesoffailureduetothenDocumentedinformationshallbeavailevolveasthedesignprogresses,throughrepeatedcyclesofdevelopmentab)reviewsareconductedtoevaluatetheabilityoftheresultsofdesignISO2025-Allrightsresed)validationactivitiesareconductedtoensurethatte)necessaryactionsaretakentoaddressproblemsdeterminedduringthereviews,orvef)documentedinformaNOTEDesignanddevelopmentreviews,verificationandvalidationhavedistinctpurposes.Theycanbeconductedseparatelyorinanycombination,asissuitabl8.3.5Designanddevelopmentb)areadequateforthe

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