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-1-为保证批量生产的认证产品与已获型式试验合格的样品的一致性，工厂应满足本文件规定的产品质量保证能力要求。Factoryshallmeettherequirementsforfactory’squalityassuranceabilityinthisdocument,inordertoensurethatallcertifiedproductsareidenticalwithinacceptedmanufacturingtolerancestothesampleorsamplesagainstwhichthetypetestwasapproved.1职责和资源/Responsibility,AuthorityandResource1.1职责/Responsibility工厂应规定与质量活动有关的各类人员职责及相互关系，且工厂应在组织内指定一名质量负责人，无论该成员在其他方面的职责如何，应具有以下方面的职责和权限：Factoryshallregulatetheresponsibilitiesandinter-relationsofallthepersonnelinvolvedinqualityactivities.Andfactoryshallappointaresponsiblepersonforqualityfromtheorganizationwho,irrespectiveofotherresponsibilities,shallhaveresponsibilityandauthoritythatinclude.a.负责建立满足本文件要求的质量体系，并确保其实施和保持；Ensuringthatqualitysystem,whichmeetstherequirementsofthisdocument,isestablished,implementedandmaintained.b.确保加贴强制性认证标志的产品符合认证标准的要求；Ensuringthattheproductswiththecertificationlabelareproducedinconformitywiththestandardstowhichtheywerecertified.c.建立文件化的程序，确保认证标志的妥善保管和使用；Establishingdocumentedproceduretoensurethatcertificationlabelsarekeptandusedappropriately.d.建立文件化的程序，确保不合格品和获证产品变更后未经认证机构确认，不加贴强制性认证标志。Establishingdocumentedproceduretoensurethatthecertificationlabelisnotborneonanynon-conformingproductorchangedproductthatwasnotnotifiedbycertificationbody.质量负责人应具有充分的能力胜任本职工作。Theresponsiblepersonforqualityshallbecompetenttoperformthework.1.2资源/Resources工厂应配备必须的生产设备和检验设备以满足稳定生产符合强制性认证标准的产品要求；应配备相应的人力资源，确保从事对产品质量有影响工作的人员具备必要的能力；建立并保持适宜产品生产、检验、试验、储存等必备的环境。Factoryshallequipwithnecessaryproductionfacilityandtestingequipmentinordertoconsistentlymanufacturetheproductsinconformitywithcertificationstandards.Inaddition,factoryshallproviderelevanthumanresources,toensurethatpersonnelperformingworkaffectingproduct-2-qualityiscompetent,andestablishandmaintainnecessaryenvironmentsuitableformanufacturing,testandinspection,storageetc.2.DocumentsandRecords文件和记录2.1Factoryshallestablishandmaintaindocumentedqualityplanorrelevantdocumentsforcertifiedproducts,andneededdocumentsinordertoensurethatrelatedprocessestoproductqualityareoperatedandcontrolledeffectively.Qualityplanshalldefinetheobjectiveofproductdesign,realizationprocess,testandrelatedresource,aswellastherequirementsforchanges(i.e.standard,workshop,criticalcomponentsetc.)tocertifiedproducts,useandmanagementoflabels.工厂应建立、保持文件化的认证产品的质量计划或类似文件，以及为确保产品质量的相关过程有效运作和控制需要的文件。质量计划应包括产品设计目标、实现过程、检测及有关资源的规定，以及产品获证后对获证产品的变更（标准、工艺、关键件等）、标志的使用管理等的规定。Designstandardorspecification,asoneessentialpartofqualityplan,shallnotbelowerthantherequirementsofnationalstandardfortheproduct.产品设计标准或规范应是质量计划的一个内容,其要求应不低于有关该产品的国家标准要求。2.2Factoryshallestablishandmaintaindocumentedproceduretocontrolthedocumentsrequiredinthisdocument,toensurethat工厂应建立并保持文件化的程序以对本文件要求的文件和资料进行有效的控制。这些控制应确保：a)documentsareapprovedbyauthorizedpersonnelpriortoissueandre-approvedafterchanges.文件发布前和更改应由授权人批准，以确保其适宜性；b)changesandcurrentrevisionstatusofdocumentsareidentifiedtopreventunintendeduseofobsoletedocuments.文件的更改和修订状态得到识别，防止作废文件的非预期使用；c)relevantversionsofapplicabledocumentsareavailableatpointsofuse.确保在使用处可获得相应文件的有效版本。2.3Factoryshallestablishandmaintaindocumentedproceduretodefinethecontrolsfortheidentification,storage,protectionanddispositionofrecords.Recordsshallremainlegible,integraltoprovideevidenceofproductconformitytorequirements.2.3工厂应建立并保持质量记录的标识、储存、保管和处理的文件化程序，质量记录应清晰、完整以作为产品符合规定要求的证据。Recordsshallberetainedforanappropriateperiod.质量记录应有适当的的保存期限。3.PurchasingandIncomingInspection3采购和进货检验3.1ControlofSupplier3.1供应商的控制Factoryshallestablishtheprocedurethatdefinesthecriteriaforselection,evaluationandroutinesupervisionofsupplier,whichprovidecriticalcomponentsandmaterial,toensurethesupplierhasabilitytoprovidethecriticalcomponentsandmaterialinaccordancewithrequirements.工厂应制定对关键元器件和材料的供应商的选择、评定和日常管理的程序，以确保供应商具有保-3-证生产关键元器件和材料满足要求的能力。Recordsoftheevaluationsandroutinesupervisionshallbemaintained.工厂应保存对供应商的选择评价和日常管理记录。3.2Inspection/VerificationforCriticalComponentsandMaterial3.2关键元器件和材料的检验/验证Factoryshallestablishandmaintainprocedureofinspectionorverificationforpurchasedcriticalcomponentsandmaterial,andprocedureofperiodicverificationinspection,toensurethatcriticalcomponentsandmaterialmeetspecifiedcertificationrequirements.工厂应建立并保持对供应商提供的关键元器件和材料的检验或验证的程序及定期确认检验的程序，以确保关键元器件和材料满足认证所规定的要求。Inspectionforpurchasedcriticalcomponentsandmaterialmaybecarriedoutbyfactoryorbysupplier.Whereinspectionisperformedatsupplier’spremise,factoryshallstatetheintendedinspectionrequirementstosupplier.关键元器件和材料的检验可由工厂进行，也可以由供应商完成。当由供应商检验时,工厂应对供应商提出明确的检验要求。工厂应保存关键件检验或验证记录、确认检验记录及供应商提供的合格证明及有关检验数据等。4.MonitoringandMeasurementofProcesses4生产过程控制和过程检验4.1Factoryshallidentifycriticalproductionprocessesandarrangeoperatorswithappropriatequalificationattheprocesses.Whereproductqualitycannotbeguaranteedwhennooperatingdocument,appropriateoperatinginstructionsshallbepreparedtomakeproductionprocessesundercontrol.4.1工厂应对关键生产工序进行识别，关键工序操作人员应具备相应的能力，如果该工序没有文件规定就不能保证产品质量时，则应制定相应的工艺作业指导书，使生产过程受控。4.2Whereenvironmentconditionisrequired,factoryshallmeettherequirements.4.2产品生产过程中如对环境条件有要求,工厂应保证工作环境满足规