iso2000条文中英对照

PAGE2INTERNATIONALSTANDARDQualitymanagementsystems-RequirementsScope范围1.1General概述ThisInternationalStandardspecifiesrequirementsforaqualitymanagementwhereanorganization

本国际标准所订之品质管理系统要求，当一个组织needstodemonstrateitsabilitytoconsistentlyprovideproductthatmeetscustomerandapplicableregulatoryrequirements,and

必须展现其提供符合顾客要求及符合适用法规要求一致的产品能力，及aimstoenhancecustomersatisfactionthroughtheeffectiveapplicationofthesystem,includingprocessesforcontinualimprovementofthesystemandtheassuranceofconformitytocustomerandapplicableregulatoryrequirements.

透过对系统有效应用以增进顾客满意之目标，包含对系统的持续改善各流程和对顾客要求及适用法规要求之符合的保证NOTE InthisInternationalStandard,theterm“product”appliesonlytotheproductintendedfor,orrequiredby,acustomer.注：本国际标准内之『产品』一词是指只适用于预期的或顾客要求的产品1.2Application应用AllrequirementsofthisInternationalStandardaregenericandareintendedtobeapplicabletoallorganizations,regardlessoftype,sizeandproductprovided.

本国际标准的所有要求是通用的，并期望适用于不论型式、规模大小与所提供产品的所有组织Whereanyrequirement(s)ofthisInternationalStandardcannotbeappliedduetothenatureofanorganizationanditsproduct,thiscanbeconsideredforexclusion.

当本国际标准的任何要求因组织及其产品之性质而无法适用，可以考虑加以排除Whereexclusionsaremade,claimsofconformitytothisInternationalStandardarenotacceptableunlesstheseexclusionsarelimitedtorequirementswithinclause7,andsuchexclusionsdonotaffecttheorganization’sability,orresponsibility,toprovideproductthatmeetscustomerandapplicableregulatoryrequirements.

当排除进行时，除非这些排除被限制在条文7内之要求，且这些排除不能影响组织能力或责任，及提供实现符合顾客与适用法规要求的产品，否则无法主张符合本国际标准2 Normativereference引用标准Thefollowingnormativedocumentcontainsprovisionswhich,throughreferenceinthistext,constituteprovisionsofthisInternationalStandard.Fordatedreferences,subsequentamendmentsto,orrevisionsof,anyofthesepublicationsdonotapply.However,partiestoagreementsbasedonthisInternationalStandardareencouragedtoinvestigatethepossibilityofapplyingthemostrecenteditionofthenormativedocumentindicatedbelow.Forundatedreferences,thelatesteditionofthenormativedocumentreferredtoapplies.MembersofISOandIECmaintainregistersofcurrentlyvalidInternationalStandard.

本国际标准各项规定系由下列标准之规定所组成，并于全文中引述参考。由于所引用的标准会逐渐过时而陆续修正或改版，造成引用的国际标准不再适用。然而，使用本国际标准之各方被鼓励探讨应用下列各项标准最新版次的可能性。IEC和ISO会员则维持最新有效国际标准之登录。ISO9000:2000,Qualitymanagementsystems–Fundamentalsandvocabulary.

ISO9000：2000，品质管理系统—原则与词汇3 Termsanddefinitions用词与定义ForthepurposesofthisInternationalStandard,thetermsanddefinitionsgiveninISO9000apply.

为了本国际标准之目的，ISO9000：2000内所赋予的用词和定义适用。Thefollowingterms,usedinthiseditionofISO9001todescribethesupplychain,havebeenchangedtoreflectthevocabularycurrentlyused:

下列用词在本版国际标准中使用，用以描述供应炼，已改为反应现有使用之字汇：Supplier→organization→customer

供货商→组织→顾客Theterm“organization”replacestheterm“supplier”usedinISO9001:1994,andreferstotheunittowhichthisInternationalStandardapplies.Also,theterm“supplier”nowreplacestheterm“subcontractor”.

用词「组织」取代了以前使用的用词「供货商」，意思是使用本国际标准的单位。现在的用词「供货商」，即是以前的用词「分包商」，这些改变是因为与组织所使用字汇相对应。ThroughoutthetextofthisInternationalStandard,wherevertheterm“product”occurs,itcanalsomean“service”.

本国际标准全文上下，无论何处使用到用词「产品」，亦能够同义于「服务」4 Qualitymanagementsystem品质管理系统4.1Generalrequirements一般要求Theorganizationshallestablish,document,implementandmaintainaqualitymanagementsystemandcontinuallyimproveitseffectivenessinaccordancewiththerequirementsofthisInternationalStandard.组织应建立、文件化、执行、维持一个品质管理系统及持续不断改善其功能以符合本国际标准之要求。Theorganizationshall组织应identifytheprocessesneededforthequalitymanagementsystemandtheirapplicationthroughouttheorganization(see1.2),

鉴定品质管理系统所需之流程determinethesequenceandinteractionoftheseprocesses,

决定这些流程之顺序与其交互之关系Determinecriteriaandmethodsneededtoensurethatboththeoperationandcontroloftheseprocessesareeffective,

决定准则与方法以确保这些流程可有效运作与管制Ensuretheavailabilityofresourcesandinformationnecessarytosupporttheoperationandmonitoringoftheseprocesses,

确保有效的资源与信息的取得以支持作业和监督这些流程Monitor,measureandanalyzetheseprocesses,and

监督、量测及分析这些流程及Implementactionsnecessarytoachieveplannedresultsandcontinualimprovementoftheseprocesses.

实施措施，以达成所规画结果和持续性改善这些流程之所需。TheseprocessesshallbemanagedbytheorganizationinaccordancewiththerequirementsofthisInternationalStandard.

组织应管理这些流程，以与本国际标准要求一致。Whereanorganizationchoosestooutsourceanyprocessthataffectsproductconformitywithrequirements,theorganizationshallensurecontroloversuchprocesses.Controlofsuchoutsourcedprocessesshallbeidentifiedwithinthequalitymanagementsystem.

当一个组织选择用外部来源之任何影响产品符合要求之流程时，组织应确保能完全管制这样的流程。这样的外部资源流程的管制应在品质管理系统内加以鉴别。NOTE Processesneededforthequalitymanagementsystemreferredtoaboveshouldincludeprocessesformanagementactivities,provisionofresources,productrealizationandmeasurement.注：品质管理系统所需要的流程参照上述，包含管理、资源、产品实现和量测。4.2Documentationrequirements文件要求4.2.1General概述Thequalitymanagementsystemdocumentationshallinclude

品质管理系统文件应包含：documentedstatementsofaqualitypolicyandqualityobjectives,

品质政策和品质目标；aqualitymanual,

品质手册；documentedproceduresrequiredbythisInternationalStandard,

本国际标准所要求的书面程序；documentsneededbytheorganizationtoensuretheeffectiveplanning,operationandcontrolofitsprocesses,and

组织用以确保其流程有效的规划、作业和管制所要求的文件；recordsrequiredbythisInternationalStandard(see4.2.4).

本国际标准要求的品质记录。NOTE 1Wheretheterm“documentedprocedure”appearswithinthisInternationalStandard,thismeansthattheprocedureisestablished,documented,implementedandmaintained.注1：出现在本国际标准内的用词「书面程序」，是指要「建立、文书化、实施和维持」此程序。NOTE 2Theextentofthequalitymanagementsystemdocumentationcandifferfromoneorganizationtoanotherdueto注2：每个组织的品质管理系统文件的程度可能有别于另一个组织，可归因于：thesizeoforganizationandtypeofactivities,

组织的规模及作业的型态；thecomplexityofprocessesandtheirinteractions,and

流程的复杂性及其相互作用；thecompetenceofpersonnel.

人员的能力。NOTE 3Thedocumentationcanbeinanyformortypeofmedium.注3：文件可以是任何格式或形式的媒体。4.2.2Qualitymanual品质手册Theorganizationshallestablishandmaintainaqualitymanualthatincludes

组织应建立和维持一份品质手册。此品质手册包括以下：thescopeofthequalitymanagementsystem,includingdetailsofanjustificationforanyexclusions(see1.2)

品质管理系统的范围，包含任何删除范围的细节及调整(见1.2)；thedocumentedproceduresestablishedforthequalitymanagementsystem,orreferencetothem,and

为品质管理系统而建立的书面程序或其参考引用；adescriptionoftheinteractionbetweentheprocessesofthequalitymanagementsystem.

叙述品质管理系统内流程间的相互关系。4.2.3Controlofdocuments文件管制Documentsrequiredbythequalitymanagementsystemshallbecontrolled.Recordsarespecialtypeofdocumentandshallbecontrolledaccordingtotherequirementsgivein4.2.4.

品质管理系统所要求的文件应予以管制。品质记录是一种特殊型态的文件，应依据4.2.4项条文要求加以管制。Adocumentedprocedureshallbeestablishedtodefinethecontrolsneeded

应建立一书面程序，使得：toapprovedocumentsforadequacypriortoissue,

文件发放前批准其适切性；toreviewandupdateasnecessaryandre-approvedocuments,

审查，必要时更新并重新批准文件；toensurethatchangesandthecurrentrevisionstatusofdocumentsareidentified,

确保文件改订状况及最新版次状况已被鉴别；toensurethatrelevantversionsofapplicabledocumentsareavailableatpointsofuse,

确保使用场所可取用相关版本的适用文件；toensurethatdocumentsremainlegibleandreadilyidentifiable,

确保文件保持易读及容易辨识；toensurethatdocumentsofexternaloriginareidentifiedandtheirdistributioncontrolled,and

确保外来原始文件已被鉴别，和对其分发加以管制；topreventtheunintendeduseofobsoletedocuments,andtoapplysuitableidentificationtothemiftheyareretainedforanypurpose.

防止失效的文件被误用，若为任何目的而保留的失效文件采取适当的鉴别；4.2.4Controlofrecords品质记录管制Recordsshallbeestablishedandmaintainedtoprovideevidenceofconformitytorequirementsandoftheeffectiveoperationofthequalitymanagementsystem.Recordsshallremainlegible,readilyidentifiableandretrievable.Adocumentedprocedureshallbeestablishedtodefinethecontrolsneededfortheidentification,storage,protection,retrieval,retentiontimeanddispositionofrecords.

应建立和维持品质管理系统所要求的记录，以提供品质管理系统符合要求及有效作业之证据。品质记录应维持易读、容易辨识和调阅。应建立一书面程序以鉴别、储存、保护、调阅、保存期限及处置品质记录。5 Managementresponsibility管理责任5.1Managementcommitment管理阶层承诺Topmanagementshallprovideevidenceofitscommitmenttothedevelopmentandimplementationofthequalitymanagementsystemandcontinuallyimprovingitseffectivenessby

高阶管理阶层应藉由下述，提供其发展和改善品质管理系统及持续改善其有效性之承诺的证据：communicatingtotheorganizationtheimportanceofmeetingcustomeraswellasstatutoryandregulatoryrequirements,

对组织沟通符合顾客要求和法规及法令要求之重要性；establishingthequalitypolicy,

建立品质政策ensuringthatqualityobjectivesareestablished,

确保已建立品质目标；conductingmanagementreviews,and

执行管理阶层审查；ensuringtheavailabilityofresources.

确保资源的可用性。5.2Customerfocus顾客焦点Topmanagementshallensurethatcustomerrequirementsaredeterminedandaremetwiththeaimofenhancingcustomersatisfaction(see7.2.1and8.2.1).

高阶管理阶层应确保顾客要求已被决定，以符合达成顾客满意之目的。(见7.2.1和8.2.1)5.3Qualitypolicy品质政策Topmanagementshallensurethatthequalitypolicy

高阶管理阶层应确保品质政策：isappropriatetothepurposeoftheorganization,

合于组织目的；includesacommitmenttocomplywithrequirementsandcontinuallyimprovetheeffectivenessofthequalitymanagementsystem,

包含符合要求和持续地改善品质管理系统之有效性的承诺；providesaframeworkforestablishingandreviewingqualityobjectives,

提供一个建立和审查品质目标之架构；iscommunicatedandunderstoodwithintheorganization,

在组织内被沟通和了解；andisreviewedforcontinuingsuitability.

审查其持续适用性。5.4Planning规划5.4.1Qualityobjectives品质目标Topmanagementshallensurethatqualityobjectives,includingthoseneededtomeetrequirementsforproduct(see7.1a),areestablishedatrelevantfunctionsandlevelswithintheorganization.Thequalityobjectivesshallbemeasurableandconsistentwiththequalitypolicy.

高阶管理阶层应确保在组织内相关功能部门及阶层已建立包含产品（见7.1a）必须符合要求在内之品质目标，品质目标应可量测并与品质政策一致。5.4.2Qualitymanagementsystemplanning品质管理系统规划Topmanagementshallensurethat

高阶管理阶层应确保：theplanningofthequalitymanagementsystemiscarriedoutinordertomeettherequirementsgivenin4.1,aswellasthequalityobjectives,and

品质管理系统的规划，已符合品质目标和4.1项条文要求。theintegrityofthequalitymanagementsystemismaintainedwhenchangestothequalitymanagementsystemareplannedandimplemented.

当规划和执行品质管理系统而有所变更时，品质管理系统完整性仍加以维持。5.5Responsibility,authorityandcommunication责任、权限与沟通5.5.1Responsibilityandauthority责任与权限Topmanagementshallensurethatresponsibilitiesandauthoritiesaredefinedandcommunicatedwithintheorganization.

高阶管理阶层应确保组织内对责任、权限和其相互关系应已加以界定和沟通。5.5.2Managementrepresentative管理代表Topmanagementshallappointamemberofmanagementwho,irrespectiveofotherresponsibilities,shallhaveresponsibilityandauthoritythatincludes

高阶管理阶层应指定管理阶层的一员作为管理代表，该代表不受其它职责影响，应有的责任和权限，包括：ensuringthatprocessesneededforthequalitymanagementsystemareestablished,implementedandmaintained,

确保品质管理系统所必须的流程已建立、实施及维持；reportingtopmanagementontheperformanceofthequalitymanagementsystemandanyneedforimprovement,and

向高阶管理阶层报告品质管理系统的绩效和改善的需要；ensuringthepromotionofawarenessofcustomerrequirementsthroughouttheorganization.

确保促进组织全盘对顾客需求的认知。NOTE Theresponsibilityofamanagementrepresentativecanincludeliaisonwithexternalpartiesonmattersrelatingtothequalitymanagementsystem.注：一位管理代表的责任可包括就品质管理系统有关事务与外部团体联系。5.5.3Internalcommunication内部沟通Topmanagementshallensurethatappropriatecommunicationprocessesareestablishedwithintheorganizationandthatcommunicationtakesplaceregardingtheeffectivenessofthequalitymanagementsystem.

高阶管理阶层应确保在组织内已建立适当的沟通流程，并对有关于品质管理系统的有效性加以沟通。5.6Managementreview管理阶层审查5.6.1General概述Topmanagementshallreviewtheorganization’squalitymanagementsystem,atplannedintervals,toensureitscontinuingsuitability,adequacyandeffectiveness.Thisreviewshallincludeassessingopportunitiesforimprovementandtheneedforchangestothequalitymanagementsystem,includingthequalitypolicyandqualityobjectives.

高阶管理阶层应在所规画的期间审查组织的品质管理系统，以确保其持续适用性、适切性和有效性。此审查应包括评鉴改善机会和包括品质政策和目标在内的品质管理系统变更的需求。Recordsfrommanagementreviewsshallbemaintained(see4.2.4).

保存管理审查的记录（见4.2.4）。5.6.2Reviewinput审查输入Theinputtomanagementreviewshallincludeinformationon

输入到管理阶层审查应包括的信息，有关下列：resultsofaudits,

稽核结果；customerfeedback,

顾客回馈；processperformanceandproductconformity,

流程绩效与产品符合性；statusofpreventiveandcorrectiveactions,

预防和矫正措施的状况；follow-upactionsfrompreviousmanagementreviews,

上一次管理阶层审查的跟催措施；changesthatcouldaffectthequalitymanagementsystem,and

可能影响品质管理系统的所规划的变更；recommendationsforimprovement

为了改善的推荐。5.6.3Reviewoutput审查输出Theoutputfromthemanagementreviewshallincludeanydecisionsandactionsrelatedto

来自管理阶层审查的输出应包括下列相关的决策和措施：improvementoftheeffectivenessofthequalitymanagementsystemandrelatedto

品质管理系统和其流程的有效性之改善；improvementofproductrelatedtocustomerrequirements,and

与顾客要求有关的产品之改善；resourceneeds.

所需求的资源。6 Resourcemanagement资源管理6.1Provisionofresources资源的提供Theorganizationshalldetermineandprovidetheresourcesneeded

组织应决定和提供所需要的资源：toimplementandmaintainthequalitymanagementsystemandcontinuallyimproveitseffectiveness,and

以实施和维持品质管理系统和持续地改善其有效性；和toenhancecustomersatisfactionbymeetingcustomerrequirements.

达成顾客满意。6.2Humanresources人力资源6.2.1General概述Personnelperformingworkaffectingproductqualityshallbecompetentonthebasisofappropriateeducation,training,skillsandexperience.

执行会影响产品品质工作之人员应依适当的教育、训练、技能和经验为基础，具备能力。6.2.2Competence,awarenessandtraining能力、认知和训练Theorganizationshall组织应：determinethenecessarycompetenceforpersonnelperformingworkaffectingproductquality,

鉴别执行会影响品质活动之人员的能力需求；providetrainingortakeotheractionstosatisfytheseneeds,

提供训练或采取其它措施以满足这些需求；evaluatetheeffectivenessoftheactionstaken,

评估所采取措施的有效性；ensurethatitspersonnelareawareoftherelevanceandimportanceoftheiractivitiesandhowtheycontributetotheachievementofthequalityobjectives,and

确保组织的人员认知他们活动的关联及重要性和他们如何对于品质目标的达成有所贡献；maintainappropriaterecordsofeducation,training,skillsandexperience(see4.2.4))

维持教育、训练、技能和经验的记录(见4.2.4)。6.3Infrastructure基础设施Theorganizationshalldetermine,provideandmaintaintheinfrastructureneededtoachieveconformitytoproductrequirements.Infrastructureincludes,asapplicable

组织应鉴别、提供和维持所需的基础设施，以达成产品的符合性。基础设施可能包括：buildings,workspaceandassociatedutilities,

建物、工作空间和相关的设施；processequipment(bothhardwareandsoftware),and

流程设备，包括硬件和软件；supportservices(suchastransportorcommunication).

支持服务(如运输、通信)。6.4Workenvironment工作环境Theorganizationshalldetermineandmanagetheworkenvironmentneededtoachieveconformitytoproductrequirements.

组织应鉴别和管理工作环境所需的因素，以达成产品的符合性。7 Productrealization产品实现7.1Planningofproductrealization产品实现的规划Theorganizationshallplananddeveloptheprocessesneededforproductrealization.Planningofproductrealizationshallbeconsistentwiththerequirementsoftheotherprocessesofthequalitymanagementsystem(see4.2).

组织应规划和发展为了产品实现所需的流程。产品实现流程的规划应和组织的品质管理系统的其它要求一致。Inplanningproductrealization,theorganizationshalldeterminethefollowing,asappropriate:

在规划产品实现时，组织应适当地决定下列：qualityobjectivesandrequirementsoftheproduct;

为了产品的品质目标和要求；theneedtoestablishprocesses,documents,andprovideresourcesspecifictotheproduct;

建立流程和文件的需要，和产品所规定的资源；requiredverification,validation,monitoring,inspectionandtestactivitiesspecifictotheproductandthecriteriaforproductacceptance;

对规定产品所需的查证、确认、监督、检验和测试活动，和产品允收准则；recordsneededtoprovideevidencethattherealizationprocessesandresultingproductmeetrequirements(see4.2.4).

提供实现流程和符合要求的最终产品之证据所必须的品质记录。Theoutputofthisplanningshallbeinaformsuitablefortheorganization’smethodofoperations.

这规划的输出应以适用于组织作业的方法之型式。NOTE 1Adocumentspecifyingtheprocessesofthequalitymanagementsystem(includingtheproductrealizationprocesses)andtheresourcestobeappliedtospecificproduct,projectorcontract,canbereferredtoasaqualityplan.注1：用以叙述品质管理系统的流程（包括产品实现流程）和资源，而被应用于特定产品、项目或合约的文件，可被视为品质计画。NOTE 2Theorganizationmayalsoapplytherequirementsgivenin7.2tothedevelopmentofproductrealizationprocesses.注2：条文7.3的要求可被应用在产品实现流程的开发。7.2Customer-relatedprocesses

顾客相关的流程7.2.1Determinationofrequirementsrelatedtotheproduct

客户需求的鉴定Theorganizationshalldetermine

组织应决定：requirementsspecifiedbythecustomer,includingtherequirementsfordeliveryandpost-deliveryactivities,

顾客所规定的产品要求，包含交货和售后活动的要求。requirementsnotstatedbythecustomerbynecessaryforspecifiedorintendeduse,whereknown,

虽非顾客所规定的产品要求，但为原订或特定使用之所必须。statutoryandregulatoryrequirementsrelatedtotheproduct,and

与产品有关的法规和法令要求。anyadditionalrequirementsdeterminedbytheorganization.

任何由组织决定的额外要求。7.2.2Reviewofrequirementsrelatedtotheproduct

与产品有关之要求的审查Theorganizationshallreviewtherequirementsrelatedtotheproduct.Thisreviewshallbeconductedpriortotheorganization’scommitmenttosupplyproducttothecustomer(e.g.submissionoftenders,acceptanceofcontractsororders,acceptanceofchangestocontractsoforders)andshallensurethat

组织应审查与产品有关的要求。这审查应在决定或承诺向顾客供应产品前(亦即投标，合约或订单的接收，合约或订单的变更接收)进行，组织应确保：productrequirementsaredefined,

产品要求已加以界定；contractororderrequirementsdifferingfromthosepreviouslyexpressedareresolved,and

与先前陈述的不一致的合约或订单要求已得到解决；theorganizationhastheabilitytomeetthedefinedrequirements.

组织具有满足所界定要求的能力。Recordsoftheresultsofthereviewandactionsarisingfromthereviewshallbemaintained(see4.2.4).

审查结果和措施如审查的归结应加以记录(见4.2.4)Wherethecustomerprovidesnotdocumentedstatementofrequirement,thecustomerrequirementsshallbeconfirmedbytheorganizationbeforeacceptance.

当顾客以非书面陈述提出要求时，顾客要求应在组织接受之前加以确认。Whereproductrequirementsarechangedtheorganizationshallensurethatrelevantdocumentsareamendedandthatrelevantpersonnelaremadeawareofthechangedrequirements.

当产品要求被改变，组织应确保相关文件已被修订，且相关人员已知会变更的要求。NOTE Insomesituations,suchasinternetsales,aformalreviewisimpracticalforeachorder.Insteadthereviewcancoverrelevantproductinformationsuchascataloguesoradvertisingmaterial.注：在某些情形如网络销售，对每一订单，以正规的审查可能不切实际。取代审查可以包含相关产品信息，如型录、广告文宣等。7.2.3Customercommunication

顾客沟通Theorganizationshalldetermineandimplementeffectivearrangementsforcommunicationwithcustomersinrelationto

组织应决定和实施有效的安排，以便与顾客沟通有关于：productinformation,

产品信息；enquiries,contractsororderhandling,includingamendments,and

包括变更时的询价、合约或订单处理；customerfeedback,includingcustomercomplaint.

包括顾客抱怨在内的顾客回馈。7.3Designanddevelopment

设计和开发7.3.1Designanddevelopmentplanning

设计和开发规划Theorganizationshallplanandcontrolthedesignanddevelopmentofproduct.

组织应规划和管制产品的设计和开发。Duringthedesignanddevelopmentplanning,theorganizationshalldetermine

在设计和开发规划时，组织应决定：thedesignanddevelopmentstates,

设计和开发流程的各阶段；thereview,verificationandvalidationthatareappropriatetoeachdesignanddevelopmentstage,and

在每一设计和开发阶段适当的审查、查证及确认活动；theresponsibilitiesandauthoritiesforthedesignanddevelopment.

设计和开发活动的责任与权限。Theorganizationshallmanagetheinterfacesbetweendifferentgroupsinvolvedindesignanddevelopmenttoensureeffectivecommunicationandclearassignmentofresponsibility.

组织应管理在设计和开发流程中涉及不同小组之间的接口，以确保有效的沟通和厘清责任。Planningoutputshallbeupdated,asappropriate,asthedesignanddevelopmentprogresses.

当设计和开发进行中，适当时，规划输出应予以更新。7.3.2Designanddevelopmentinputs设计和开发输入Inputrelatingtoproductrequirementsshallbedeterminedandrecordsmaintained(see4.2.4).Theseinputsshallinclude

与产品要求有关的输入应加以决定与记录(见4.2.4)。这些应包括：functionalandperformancerequirements,

功能及效能的要求；applicablestatutoryandregulatoryrequirements,

适用的法规和法令的要求；whereapplicable,informationderivedfromprevioussimilardesigns,and

当适用时，源于以前类似设计的信息，和；otherrequirementsessentialfordesignanddevelopment.

其它对设计和开发不可或缺的要求。Theseinputsshallbereviewedforadequacy.Requirementsshallbecomplete,unambiguousandnotinconflictwitheachother.

这些输入应审查其适切性。要求应完整、不含糊不清且不与其它要求相互矛盾。7.3.3Designanddevelopmentoutputs

设计和开发输出Theoutputsofdesignanddevelopmentshallbeprovidedinaformthatenablesverificationagainstthedesignanddevelopmentinputandshallbeapprovedpriortorelease.

设计和开发流程的输出应提供以能对应设计和开发输入查证的型式，且发行前应予以核准。Designanddevelopmentoutputsshall

设计和开发的输出应：meettheinputrequirementsfordesignanddevelopment,

符合设计和开发输入要求；provideappropriateinformationforpurchasing,productionandforserviceprovision,

为采购、生产和服务的供应提供适当的信息；containorreferenceproductacceptancecriteria,and

包含或引用产品允收准则；specifythecharacteristicsoftheproductthatareessentialforitssafeandproperuse.

规定产品在安全及正常使用的必要的产品特性。7.3.4Designanddevelopmentreview

设计和开发审查Atsuitablestages,systematicreviewsofdesignanddevelopmentshallbeperformedinaccordancewithplannedarrangements(see7.3.1)

在适当阶段，应进行设计和开发的系统性审查，以：toevaluatetheabilityoftheresultsofdesignanddevelopmenttomeetrequirements,and

评估设计和开发的结果以达成要求的能力；toidentifyanyproblemsandproposenecessaryactions.

鉴别任何问题，并提出所需的措施。Participantsinsuchreviewsshallincluderepresentativesoffunctionsconcernedwiththedesignanddevelopmentstage(s)beingreviewed.Recordsoftheresultsofthereviewsandanynecessaryactionsshallbemaintained(see4.2.4).

参与这类审查的人员应包括与被审查的设计和/或开发阶段有关的功能部门代表。因审查而提出的审查结果和措施应予以记录。(见4.2.4)7.3.5Designanddevelopmentverification

设计和开发查证Verificationshallbeperformedinaccordancewithplannedarrangements(see7.3.1)toensurethatthedesignanddevelopmentoutputshavemetthedesignanddevelopmentinputrequirements.Recordsoftheresultsoftheverificationandanynecessaryactionsshallbemaintained(see4.2.4).

应执行查证，以确保设计和开发输出符合设计和开发输入。查证的结果和任何所需的措施应予以记录。(见4.2.4)7.3.6Designanddevelopmentvalidation

设计和开发确认Designanddevelopmentvalidationshallbeperformedinaccordancewithplannedarrangements(see7.3.1)toensurethattheresultingproductiscapableofmeetingtherequirementsforthespecifiedapplicationorintendeduse,whereknown.Whereverpracticable,validationshallbecompletedpriortothedeliveryorimplementationoftheproduct.Recordsoftheresultsofvalidationandanynecessaryactionsshallbemaintained(see4.2.4).

应依据规划的安排(见7.3.1)执行设计和开发确认，以确保最终产品有能力满足其原订或特定使用或应用上的要求。适当时，确认应在产品交货前或实施前完成。确认的结果和任何所需的措施应予以记录。(见4.2.4)7.3.7Controlofdesignanddevelopmentchanges

设计和开发变更的管制Designanddevelopmentchangesshallbeidentifiedandrecordsmaintained.Thechangesshallbereviewed,verifiedandvalidated,asappropriate,andapprovedbeforeimplementation.Thereviewofdesignanddevelopmentchangesshallincludeevaluationoftheeffectofthechangesonconstituentpartsandproductalreadydelivered.

设计和开发变更应予以鉴别和记录。适当时，变更应加以审查、查证和确认，并于实施前核准。设计和开发变更应包含评估所构成零组件和已交货的产品因变更的影响。Recordsoftheresultsofthereviewofchangesandanynecessaryactionsshallbemaintained(see4.2.4).

变更审查的结果和任何所需的措施应加以记录。(见4.2.4)7.4Purchasing

采购7.4.1Purchasingprocess

采购流程Theorganizationshallensurethatpurchasedproductconformstospecifiedpurchaserequirements.Thetypeandextentofcontrolappliedtothesupplierandthepurchasedproductshallbedependentupontheeffectofthepurchasedproductonsubsequentproductrealizationorthefinalproduct.

组织应确保采购的产品能符合所订要求。应用于供货商和采购的产品之管制的的方式和程度应依采购的产品对后续的产品实现或最终产品的冲击而定。Theorganizationshallevaluateandselectsuppliersbasedontheirabilitytosupplyproductinaccordancewiththeorganization’srequirements.Criteriaforselection,evaluationandre-evaluationshallbeestablished.Recordsoftheresultsofevaluationsandanynecessaryactionsarisingfromtheevaluationshallbemaintained(see4.2.4).

组织应基于供应与组织要求一致之产品的能力来评估和选择供货商。应建立选择供货商、评估和再评估的准则。来自评估而提出的评估的结果和措施应予以记录。(见4.2.4)7.4.2Purchasinginformation

采购信息Purchasinginformationshalldescribetheproducttobepurchased,includingwhereappropriate

采购文件应描述所采购产品的信息，适当时包括：requirementsforapprovalofproduct,procedures,processesandequipment,

为了产品、程序、流程、设施和设备核准的要求；requirementsforqualificationofpersonnel,and

为了人员资格之要求；qualitymanagementsystemrequirements.

品质管理系统要求。Theorganizationshallensuretheadequacyofspecifiedpurchaserequirementspriortotheircommunicationtothesupplier.

组织应确保在与供货商沟通前对所订要求之适切性。7.4.3Verificationofpurchasedproduct

采购产品的查证Theorganizationshallestablishandimplementtheinspectionorotheractivitiesnecessaryforensuringthatpurchasedproductmeetsspecifiedpurchaserequirements.

组织应建立和实施为了确保采购的产品符合所订要求所必须的检验或其它活动。Wheretheorganizationoritscustomerintendstoperformverificationatthesupplier’spremises,theorganizationshallstatetheintendedverificationarrangementsandmethodofproductreleaseinthepurchasinginformation.

当组织或其顾客拟在供货商现场进行查证时，组织应在采购信息中规定所订的查证安排和产品放行的方法。7.5Productionandserviceprovision

生产和服务运作7.5.1Controlofproductionandserviceprovision

生产和服务运作管制Theorganizationshallplanandcarryoutproductionandserviceprovisionundercontrolledconditions.Controlledconditionsshallinclude,asapplicable

组织应在既定规划和管制的条件下，执行生产和服务的供应，适当时，包括：theavailabilityofinformationthatdescribesthecharacteristicsoftheproduct,

规定产品特性信息的可用性；theavailabilityofworkinstructions,asnecessary,

当需要时，工作指导书之可用性；theuseofsuitableequipment,

为了生产和服务的供应而使用适当的设备；theavailabilityanduseofmonitoringandmeasuringdevices,

监督和量测装置的可用性和使用；theimplementationofmonitoringandmeasurement,and

监督和量测活动的实施；theimplementationofrelease,deliveryandpost-deliveryactivities.

产品放行、交货和售后活动的实施。7.5.2Validationofprocessesforproductionandserviceprovision

生产和服务运作流程确认Theorganizationshallvalidateanyprocessesforproductionandserviceprovisionwheretheresultingoutputcannotbeverifiedbysubsequentmonitoringormeasurement.Thisincludesanyprocesseswheredeficienciesbecomeapparentonlyaftertheproductisinuseortheservicehasbeendelivered.

组织应确认其最终输出不能由随后的监督和量测来查证的任何生产和服务供应流程。这包括可能因产品使用后或服务已经提供后才显现出失效的任何流程。Validationshalldemonstratetheabilityoftheseprocessestoachieveplannedresults.

确认应展现流程达到规划结果的能力。Theorganizationshallestablisharrangementsfortheseprocessesincluding,asapplicable

组织应对确认的安排加以界定，适当时应考虑以下要求：definedcriteriaforreviewandapprovaloftheprocesses,

流程的资格；approvalofequipmentandqualificationofpersonnel,

设备和人员的资格；useofspecificmethodsandprocedures,

已界定的方法和程序的使用；requirementsforrecords(see4.2.4),and

记录所要求；revalidation.

重新确认。7.5.3Identificationandtraceability

鉴别与追溯性Whereappropriate,theorganizationshallidentifytheproductbysuitablemeansthroughoutproductrealization.

适当时，组织应对产品藉由适当的方法，于产品实现各阶段予以鉴别。Theorganizationshallidentifytheproductst