ISO-TS169492009质量管理体系中英文对照版教学文案

1、Good is good, but better carries it.精益求精，善益求善。ISO-TS169492009质量管理体系中英文对照版-ISO/TS16949：2009技术规范TECHNICALSPECIFICATION质量管理体系汽车生产件及相关服务件组织应用ISO9001:2008的特殊要求QualitymanagementsystemsParticularrequirementsfortheapplicationofISO9001:2008forautomotiveproductionandrelevantservicepartorganizations目录Contents前

2、言Foreword7有关认证的说明Remarksforcertification9引言Introduction100.1总则General100.2过程方法Processapproach110.3与ISO9004的关系RelationshipwithISO9004130.4与其他管理体系的相容性Compatibilitywithothermanagementsystems140.5本技术规范的目的GoalofthisTechnicalSpecification151范围Scope161.1总则General161.2应用Application172引用标准Normativereference1

3、73术语和定义Termsanddefinitions183.1汽车行业术语和定义Termsanddefinitionsfortheautomotiveindustry184质量管理体系Qualitymanagementsystem204.1总要求Generalrequirements204.1.1总要求补充GeneralrequirementsSupplemental214.2文件要求Documentationrequirements214.2.1总则General214.2.2质量手册Qualitymanual224.2.3文件控制Controlofdocuments22工程规范Engine

4、eringspecifications234.2.4记录控制Controlofrecords23记录保存Recordsretention245管理职责Managementresponsibility245.1管理承诺Managementcommitment245.1.1过程效率Processefficiency245.2以顾客为关注焦点Customerfocus245.3质量方针Qualitypolicy255.4策划Planning255.4.1质量目标Qualityobjectives25质量目标补充QualityobjectivesSupplemental255.4.2质量管理体系的策划

5、Qualitymanagementsystemplanning265.5职责、权限与沟通Responsibility,authorityandcommunication265.5.1职责和权限Responsibilityandauthority26质量职责Responsibilityforquality265.5.2管理者代表Managementrepresentative27顾客代表Customerrepresentative275.5.3内部沟通Internalcommunication275.6管理评审Managementreview275.6.1总则General27质量管理体系绩效Q

6、ualitymanagementsystemperformance285.6.2评审输入Reviewinput28评审输入补充ReviewinputSupplemental285.6.3评审输出Reviewoutput296资源管理Resourcemanagement296.1资源提供Provisionofresources296.2人力资源Humanresources296.2.1总则General306.2.2能力、培训和意识Competence,trainingandawareness30产品设计技能Productdesignskills30培训Training31岗位培训31员工的激励

7、Employeemotivationandempowerment316.3基础设施Infrastructure316.3.1工厂、设施和设备策划Plant,facilityandequipmentplanning326.3.2应急计划Contingencyplans326.4工作环境Workenvironment326.4.1为达成产品要求符合性的人员安全Personnelsafetytoachieveconformityproductrequirements326.4.2生产现场的清洁Cleanlinessofpremises327产品实现Productrealization337.1产品实

8、现的策划Planningofproductrealization337.1.1产品实现的策划补充PlanningofproductrealizationSupplemental347.1.2接收准则Acceptancecriteria347.1.3保密性Confidentiality347.1.4更改控制Changecontrol347.2与顾客有关的过程Customer-relatedprocesses347.2.1与产品有关的要求的确Determinationofrequirementsrelatedtotheproduct35顾客指定的特殊特性Customer-designatedspe

9、cialcharacteristics357.2.2与产品有关的要求的评审Reviewofrequirementsrelatedtotheproduct35与产品有关的要求的评审补充ReviewofrequirementsrelatedtotheproducSupplemental36组织制造可行性Organizationmanufacturingfeasibility367.2.3顾客沟通Customercommunication36顾客沟通补充CustomercommunicationSupplemental377.3设计和开发Designanddevelopment377.3.1设计和开

10、发策划Designanddevelopmentplanning37多方论证方法Multidisciplinaryapproach377.3.2设计和开发输入Designanddevelopmentinputs38产品设计输入Productdesigninput38制造过程设计输入Manufacturingprocessdesigninput39特殊特性Specialcharacteristics397.3.3设计和开发输出Designanddevelopmentoutputs39产品设计输出补充ProductdesignoutputsSupplemental40制造过程设计输出Manufact

11、uringprocessdesignoutput407.3.4设计和开发评审Designanddevelopmentreview41监视Monitoring417.3.5设计和开发验证Designanddevelopmentverification427.3.6设计和开发确认Designanddevelopmentvalidation42设计和开发确认补充DesignanddevelopmentvalidationSupplemental42样件计划Prototypeprogramme42产品批准过程Productapprovalprocess437.3.7设计和开发更改的控制Controlo

12、fdesignanddevelopmentchanges437.4采购Purchasing437.4.1采购过程Purchasingprocess44法规符合性Regulatoryconformity44供方质量管理体系开发Supplierqualitymanagementsystemdevelopment44顾客批准的供方Customer-approvedsources447.4.2采购信息Purchasinginformation457.4.3采购产品的验证Verificationofpurchasedproduct45进货产品对要求的符合性Incomingproductconformit

13、ytorequirements45对供方监视Suppliermonitoring467.5生产和服务提供Productionandserviceprovision467.5.1生产和服务提供的控制Controlofproductionandserviceprovision46控制计划Controlplan47作业指导书Workinstructions47作业准备验证Verificationofjobsetups47预防性和预见性维护Preventiveandpredictivemaintenance48生产工装的管理Managementofproductiontooling48生产计划Prod

14、uctionscheduling49服务信息反馈Feedbackofinformationfromservice49与顾客的服务协议Serviceagreementwithcustomer497.5.2生产和服务提供过程的确认Validationofprocessesforproductionandserviceprovision49生产和服务提供过程的确认补充ValidationofprocessesforproductionandserviceprovisionSupplemental507.5.3标识和可追溯性Identificationandtraceability50标识和可追溯性补

15、充IdentificationandtraceabilitySupplemental507.5.4顾客财产Customerproperty51顾客所有的工装Customer-ownedproductiontooling517.5.5.产品防护Preservationofproduct51贮存和库存Storageandinventory517.6监视和测量设备的控制Controlofmonitoringandmeasuringequipment527.6.1测量系统分析Measurementsystemanalysis537.6.2校准/验证记录Calibration/verificationr

16、ecords537.6.3实验室要求Laboratoryrequirements53内部实验室Internallaboratory53外部实验室Externallaboratory548测量、分析和改进Measurement,analysisandimprovement548.1总则General558.1.1统计工具的确定Identificationofstatisticaltools558.1.2基础统计概念知识Knowledgeofbasicstatisticalconcepts558.2监视和测量Monitoringandmeasurement558.2.1顾客满意Customersa

17、tisfaction55顾客满意补充CustomersatisfactionSupplemental568.2.2内部审核Internalaudit56质量管理体系审核Qualitymanagementsystemaudit57制造过程审核Manufacturingprocessaudit57产品审核Productaudit57内部审核计划Internalauditplans57内审员资格Internalauditorqualification578.2.3过程的监视和测量Monitoringandmeasurementofprocesses58制造过程的监视和测量Monitoringandm

18、easurementofmanufacturingprocesses588.2.4产品的监视和测量Monitoringandmeasurementofproduct59全尺寸检验和功能试验Layoutinspectionandfunctionaltesting59外观项目Appearanceitems608.3不合格品控制Controlofnonconformingproduct608.3.1不合格品控制补充ControlofnonconformingproductSupplemental618.3.2返工产品的控制Controlofreworkedproduct618.3.3顾客通知Cust

19、omerinformation618.3.4顾客特许Customerwaiver618.4数据分析Analysisofdata618.4.1数据分析和使用Analysisanduseofdata628.5改进Improvement628.5.1持续改进Continualimprovement62组织的持续改进Continualimprovementoftheorganization62制造过程的改进Manufacturingprocessimprovement628.5.2纠正措施Correctiveaction63解决问题的方法Problemsolving63防错Error-proofing

20、63纠正措施影响Correctiveactionimpact63拒收产品的试验/分析Rejectedproducttest/analysis638.5.3预防措施Preventiveaction64附录A控制计划AnnexA(normative)Controlplan65参考文献Bibliography67前言Foreword国际标准化组织(ISO)是由各国标准化机构（ISO成员机构）组成的世界性联合会。国际标准的拟定由ISO技术委员会负责。各成员机构若对某技术委员会所选定的主题感兴趣，均有权参加该委员会的工作。与ISO保持联系的各国组织(官方的或非官方的)也可参加该项工作。ISO与国际电器委

21、员会（IEC）在电工技术标准化方面保持密切合作的关系。ISO(theInternationalOrganizationforStandardization)isaworldwidefederationofnationalstandardsbodies(ISOmemberbodies).TheworkofpreparingInternationalStandardsisnormallycarriedoutthroughISOtechnicalcommittees.Eachmemberbodyinterestedinasubjectforwhichatechnicalcommitteehasbee

22、nestablishedhastherighttoberepresentedonthatcommittee.Internationalorganizations,governmentalandnon-governmental,inliaisonwithISO,alsotakepartinthework.ISOcollaboratescloselywiththeInternationalElectrotechnicalCommission(IEC)onallmattersofelectrotechnicalstandardization.本国际标准是依照ISO/IEC导则第2部分中的规则制定的。

23、InternationalStandardsaredraftedinaccordancewiththerulesgivenintheISO/IECDirectives,Part2.技术委员会的主要任务是制定国际标准。本国际技术标准草案已由技术委员会通过，并传阅各成员机构一共投票表决。国际标准的公布需要至少75%的参加投票的成员团体批准。Themaintaskoftechnicalcommitteesistoprepareinternationalstandards.DraftInternationalStandardsadoptedbythetechnicalcommitteesarecirc

24、ulatedtothememberbodiesforvoting.Publicationasaninternationalstandardrequiresapprovalbyatleast75%ofthememberbodiescastingavote.在其它情况下，特别是在市场急需某个文件时，技术委员会可以决定出版其他形式的规范文件：Inothercircumstances,particularlywhenthereisanurgentmarketrequirementforsuchdocuments,atechnicalcommitteemaydecidetopublishothertyp

25、esofnormativedocument:ISO公布的可获得规范（ISO/PAS）代表一项在一个ISO工作小组内的技术专家达成的协议，在相应委员会的成员的投票中有50%投票赞成后就可以出版发行；anISOPubliclyAvailableSpecification(ISO/PAS)representsanagreementbetweentechnicalexpertsinanISOworkinggroupandisacceptedforpublicationifitisapprovedby50%ofthemembersoftheparentcommitteecastingavote;ISO技

26、术规范（ISO/TS），是技术委员会成员之间达成的协议，在委员会成员所投票中有2/3投票赞成后就可以出版发行。anISOTechnicalSpecification(ISO/TS)representsanagreementbetweenthemembersofatechnicalcommitteeandisacceptedforpublicationifitisapprovedby2/3ofthemembersofthecommitteecastingavote.ISO/TS16949是由国际汽车工业特别行动小组（IATF），在ISO/TC176质量管理和质量保证技术委员会支持下制定的。ISO

27、/TS16949waspreparedbytheInternationalAutomotiveTaskForce(IATF)withsupportfromISO/TC176,Qualitymanagementandqualityassurance.通过根据ISO9001:2008所作的技术修订，第三版的ISO/TS16949取消并替代了第二版(ISO/TS16949:2002)ThisthirdeditionofISO/TS16949cancelsandreplacesthesecondedition(ISO/TS16949:2002),whichhasbeentechnicallyamend

28、edaccordingtoISO9001:2008.方框内的文本是ISO9001：2008的原文内容，方框外是行业特殊补充的要求。BoxedtextisoriginalISO9001:2008text.Thesector-specificsupplementalrequirementsareoutsidetheboxes.在本技术规范中，“应”（shall）表示要求，“应当”（should）表示建议。标示有“注”（NOTE）的段落是对理解或澄清相关要求的指南。InthisTechnicalSpecification,theword“shall”indicatesarequirement.The

29、word“should”indicatesarecommendation.Paragraphsmarked“NOTE”areforguidanceinunderstandingorclarifyingtheassociatedrequirement.所有用“例如”引出的建议都只具有指导性作用.Wheretheterm“suchas”isused,anysuggestionsgivenareforguidanceonly.附录A是本技术规范的引用文件，构成技术规范的一部分。AnnexAformsanormativepartofthisTechnicalSpecification.有关认证的说明R

30、emarksforcertification按照IATF的认证方案（见IATF认可规则）所获取的本技术规范的认证，包括任何的顾客特殊要求（如果有），将获得IATF的顾客成员的认可。详细情况可以从以下的国际汽车推动小组的当地监督办公室处获得：意大利汽车工业协会(ANFIA)www.anfia.it美国国际汽车监督署(IAOB)IATF-F英国汽车制造与贸易商谢(SMMT)www.smmt.co.uk德国汽车工业协会-质量管理中心(VDA-QMC)www.vda-qmc.deThecertificationtothisTechnicalSpecification,includingcustomer

31、-specificrequirementsifany,isrecognizedbythecustomermembersofIATFwhenachievedaccordingtotheIATFcertificationscheme(seethe“RulesforachievingIATFrecognition”).DetailscanbeobtainedattheaddressesofthelocaloversightofficesofIATFcitedbelow:AssociazioneNazionaleFraIndustrieAutomobilistiche(ANFIA)Website:ww

32、w.anfia.itInternationalAutomotiveOversightBureau(IAOB)Website:IATF-FranceWebsite:SocietyofMotorManufacturersandTradersLtd.(SMMTLtd.)Website:www.smmt.co.ukVerbandderAutomobilindustrieQualit?tsmanagementCenter(VDA-QMC)Website:www.vda-qmc.de引言Introduction0.1总则GeneralISO9001:2008质量管理体系要求ISO9001:2008Qual

33、itymanagementsystemsRequirements引言Introduction0.1总则General采纳质量管理体系是组织的一项战略性决策。一个组织的质量管理体系的设计和实施受下列因素的影响：Theadoptionofaqualitymanagementsystemshouldbeastrategicdecisionofanorganization.Thedesignandimplementationofanorganizationsqualitymanagementsystemisinfluencedby:a)组织的环境、该环境的变化或与该环境有关的风险；b)组织不断变化的需

34、求；c)组织的具体目标；d)组织所提供的产品；e)组织所采用的过程；f)组织的规模和组织结构。a)Itsorganizationalenvironment,changesinthatenvironment,andtherisksassociatedwiththatenvironment;b)Itsvaryingneeds;c)Itsparticularobjectives;d)Theproductsitprovides;e)Theprocessesitemploys;f)Itssizeandorganizationalstructure.统一质量管理体系的结构或文件不是本标准的目的。Itisn

35、ottheintentofthisInternationalStandardtoimplyuniformityinthestructureofqualitymanagementsystemsoruniformityofdocumentation.本标准规定的质量管理体系要求是对产品要求的补充。“注”是理解和说明有关要求的指南。ThequalitymanagementsystemrequirementsspecifiedinthisInternationalStandardarecomplementarytorequirementsforproducts.Informationmarked.“N

36、OTE”isforguidanceinunderstandingorclarifyingtheassociatedrequirement.本标准能用于内部和外部（包括认证机构）评价组织满足顾客、适用于产品的法律法规要求和组织自身要求的能力。ThisInternationalStandardcanbeusedbyinternalandexternalparties,includingcertificationbodies,toassesstheorganizationsabilitytomeetcustomer,regulatoryandtheorganizationsownrequiremen

37、ts.本标准的制定已经考虑了GB/T19000和GB/T19004中所阐明的质量管理原则。ThequalitymanagementprinciplesstatedinISO9000andISO9004havebeentakenintoconsiderationduringthedevelopmentofthisInternationalStandard.0.2过程方法ProcessapproachISO9001:2008质量管理体制体系要求ISO9001:2008QualitymanagementsystemsRequirements本标准鼓励在建立、实施质量管理体系以及在改进其有效性时采用过

38、程方法，通过满足顾客要求，增强顾客满意度。ThisInternationalStandardpromotestheadoptionofaprocessapproachwhendeveloping,implementingandimprovingtheeffectivenessofaqualitymanagementsystem,toenhancecustomersatisfactionbymeetingcustomerrequirements.为了使组织有效运行，应确定和管理许多相互联系的活动。通过使用资源和管理，将输入转换为输出的一项或一组活动，可视为一个过程，通常，一个过程的输出直接形成下

39、一个过程的输入。Foranorganizationtofunctioneffectively,ithastodetermineandmanagenumerouslinkedactivities.Anactivityusingresources,andmanagedinordertoenablethetransformationofinputsintooutputs,canbeconsideredasaprocess.Oftentheoutputfromoneprocessdirectlyformstheinputtothenext.为了产生期望的结果，由过程组成的系统在组织内的应用，连同这些过

40、程的识别和相互作用，以及对这些过程的管理，可称之为“过程方法”。Theapplicationofasystemofprocesseswithinanorganization,togetherwiththeidentificationandinteractionsoftheseprocesses,andtheirmanagementtoproducethedesiredoutcome,canbereferredtoasthe“processapproach”.过程方法的一个优点是对过程系统中单个过程之间的联系以及过程的组合和相互作用进行连续的控制。Anadvantageoftheprocessa

41、pproachistheongoingcontrolthatitprovidesoverthelinkagebetweentheindividualprocesseswithinthesystemofprocesses,aswellasovertheircombinationandinteraction.在质量管理体系应用过程方法时，强调以下方面的重要性：a)理解和满足要求；b)需要从增值的角度考虑过程；c)获得过程绩效和有效性的结果；d)在客观测量的基础上，持续改进过程。Whenusedwithinaqualitymanagementsystem,suchanapproachemphasiz

42、estheimportanceof:a)Understandingandfulfillingrequirements;b)Theneedtoconsiderprocessesintermsofaddedvalue;c)Obtainingresultsofprocessperformanceandeffectiveness;andd)Continualimprovementofprocessesbasedonobjectivemeasurement.图1所反映的以过程为基础的质量管理体系模式展示了第4章至第8章中所提出的过程联系。该图反映了在规定输入要求时，顾客起着重要的作用。对顾客满意的监视，

43、要求组织对顾客关于组织是否已满足其要求的感受信息进行评价。该模式虽覆盖了本标准的所有要求，但却未详细地反映各过程。Themodelofaprocess-basedqualitymanagementsystemshowninFigure1illustratestheprocesslinkagespresentedinclauses4to8.Thisillustrationshowsthatcustomersplayasignificantroleindefiningrequirementsasinputs.Monitoringofcustomersatisfactionrequirestheev

44、aluationofinformationrelatingtocustomerperceptionastowhethertheorganizationhasmetthecustomerrequirements.ThemodelshowninFigure1coversalltherequirementsofthisInternationalStandard,butdoesnotshowprocessesatadetailedlevel.注：此外，称之为“PDCA”的方法可适用于所有过程。PDCA模式可简述如下：P策划：根据顾客的要求和组织的方针，为提供结果建立必要的目标和过程；D实施：实施过程；

45、C检查：根据方针、目标和产品要求，对过程和产品进行监视和测量，并报告结果；A处置：采取措施，以持续改进过程业绩。NOTE:Inaddition,themethodologyknownasPlan-Do-Check-Act(PDCA)canbeappliedtoallprocesses.PDCAcanbebrieflydescribedasfollows:Plan:establishtheobjectivesandprocessesnecessarytodeliverresultsinaccordancewithcustomerrequirementsandtheorganizationspol

46、icies;Do:implementtheprocesses;Check:monitorandmeasureprocessesandproductagainstpolicies,objectivesandrequirementsfortheproductandreporttheresults;Act:takeactionstocontinuallyimproveprocessperformance.0.3与ISO9004的关系RelationshipwithISO9004ISO9001:2008质量管理体制体系要求ISO9001:2008QualitymanagementsystemsRequ

47、irements0.3与ISO9004的关系RelationshipwithISO9004ISO9001和ISO9004都是质量管理体系标准，这两项标准相互补充，但也可单独使用。ISO9001andISO9004arequalitymanagementsystemstandardswhichhavebeendesignedtocomplementeachother,butcanalsobeusedindependently.ISO9001规定了质量管理体系要求，可供组织内部使用，也可用于认证或合同目的。ISO9001所关注的是质量管理体系在满足顾客要求方面的有效性。ISO9001specifi

48、esrequirementsforaqualitymanagementsystemthatcanbeusedforinternalapplicationbyorganizations,orforcertification,orforcontractualpurposes.Itfocusesontheeffectivenessofthequalitymanagementsysteminmeetingcustomerrequirements.在本标准发布时，ISO9004处于修订中。修订后的ISO9004将为组织在复杂、要求更高和不断变化的环境中获得持续成功提供管理指南。与ISO9001相比，IS

49、O9004关注质量管理的更宽范围；通过系统和持续改进组织的绩效，满足所有相关方的需求和期望。然而ISO9004不拟于用于认证、法律法规和合同的目的。AtthetimeofpublicationofthisInternationalStandard,ISO9004isunderrevision.TherevisededitionofISO9004willprovideguidancetomanagementforachievingsustainedsuccessforanyorganizationinacomplex,demanding,andeverchanging,environment.I

50、SO9004providesawiderfocusonqualitymanagementthanISO9001;itaddressestheneedsandexpectationsofallinterestedpartiesandtheirsatisfaction,bythesystematicandcontinualimprovementoftheorganizationsperformance.However,itisnotintendedforcertification,regulatoryorcontractualuse.注：应当由最高管理者在组织内宣传和贯彻ISO9000：2005和

51、ISO9004中涉及的八项质量管理原则的知识及其应用。Note:TheknowledgeanduseoftheeightqualitymanagementprinciplesreferredtointheISO9000:2005andISO9004shouldbedemonstratedandcascadedthroughtheorganizationbytopmanagement.0.4与其它管理体系的相容性CompatibilitywithothermanagementsystemsISO9001:2008质量管理体制体系要求ISO9001:2008Qualitymanagementsys

52、temsRequirements0.4与其它管理体系的相容性为方便使用者，本标准在起草过程中适当的考虑了ISO14001-2004标准的内容，以增强两类标准的相容性。附录A表明了ISO9001-2008与ISO14001-2004之间的对应关系。Duringthedevelopmentofthisinternationalstandard,dueconsiderationwasgiventotheprovisionofISO14001:2004toenhancethecompatibilityofthetwostandardsforbenefitoftheusercommunity.Annex

53、ashowsthecorrespondencebetweenISO14001:2004.本国际标准不包括其它管理体系所规定的要求，例如环境管理，职业健康和安全管理，财务管理或风险管理。然而本国际标准能够使组织的质量管理体系与有关的管理体系要求相互结合或一体化。组织为了建立符合本国际标准要求的质量管理体系，有可能会改变其现有的管理体系。ThisInternationalStandarddoesnotincluderequirementsspecifictoothermanagementsystems,suchasthoseparticulartoenvironmentalmanagement,o

54、ccupationalhealthandsafetymanagement,financialmanagementorriskmanagement.However,thisInternationalStandardenablesanorganizationtoalignorintegrateitsownqualitymanagementsystemwithrelatedmanagementsystemrequirements.Itispossibleforanorganizationtoadaptitsexistingmanagementsystem(s)inordertoestablishaq

55、ualitymanagementsystemthatcomplieswiththerequirementsofthisInternationalStandard。0.5ISO/TS16949的目的GoalofthisTechnicalSpecification本技术规范的目标是在供应链中建立持续改进，强调缺陷预防，减少变差和浪费的质量管理体系。ThegoalofthisTechnicalSpecificationisthedevelopmentofaqualitymanagementsystemthatprovidesforcontinualimprovement,emphasizingdef

56、ectpreventionandthereductionofvariationandwasteinthesupplychain.本技术规范与适当的顾客特殊要求相结合，规定了签署本文件顾客的基本质量管理体系要求。ThisTechnicalSpecification,coupledwithapplicablecustomer-specificrequirements,definesthefundamentalqualitymanagementsystemrequirementsforthosesubscribingtothisTechnicalSpecification.本技术规范旨在避免多重认证

57、审核，并为汽车生产件及服务件的组织建立质量管理体系提供了一个通用的方法。ThisTechnicalSpecificationisintendedtoavoidmultiplecertificationauditsandprovideacommonapproachtoaqualitymanagementsystemforautomotiveproduction,andrelevantservicepartorganizations.质量管理体系汽车行业生产件下相关服务件的组织实施ISO9001:2008的特殊要求QualitymanagementsystemsParticularrequirem

58、entsfortheapplicationofISO9001:2008forautomotiveproduction,andrelevantservicepartorganizations1范围Scope1.1总则GeneralISO9001:2008质量管理体系要求ISO9001:2008QualitymanagementsystemsRequirements本标准为有下列需求的组织规定了质量管理体系要求：a)需要证实其具有稳定地提供满足顾客和适用的法律法规要求的产品的能力；b)通过体系的有效应用，包括体系持续改进的过程的有效应用，以及保证符合顾客与适用的法律法规要求，旨在增强顾客满意。Th

59、isInternationalStandardspecifiesrequirementsforaqualitymanagementsystemwhereanorganization:a)Needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements;andb)Aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocesses

60、forcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicableregulatoryrequirements.注1：在本标准中，术语”产品”仅适用于：a)预期提供给顾客的或顾客所要求的产品；b)产品实现过程所产生的任何预期输出。注2：法律法规要求可称作法定要求。NOTE1:InthisInternationalStandard,theterm“product”onlyappliesto:a)productintendedfor,orrequiredby,acustomer;b)Andinte