ISO9001质量体系审核文件资料清单全套中英文对照表.docx

IS09001质量体系审核文件资料清单全套中英文对照表1营业执照(BUSineSSIiCenSe)yes2质量体系认证证书(Qua1itysystemcertificate)yes3组织架构图(OrganiZatie)nchart)yes4质量手册(QUa1itymanUa1)yes5程序文件(ProCedUredOCUmentS)yes6质量体系内审计划(QMSinterna1auditp1an)7质量体系内审记录(Interna1auditrecordsofqua1itysystem)7.1内审员资格证书(Interna1auditorqua1ificationcertificate)yes7.2首末次会议(Firstand1astmeeting)7.3检查表(Check1ist)7.4不符合项报告(Nonconformancereport)7.5内审报告(Interna1auditreport)8质量体系管理评审计划(Qua1itysystemmanagementreviewp1an)9质量体系管理评审记录(QUa1itysystemmanagementreviewrecords)9.1管理评审会议记录(Minutesofmanagementreviewmeeting)1.2 管理评审报告(ManagementReVieWRePOrt)1.3 决议事项的跟进记录(Fo11owuprecordofreso1utions)10 主要生产设备清单(1istofmainproductionequipment)11 设备保养计划(EqUiPmentmaintenanCePIan)12 设备保养记录(Equipmentmaintenancerecords)13 仪器清单(InStrUment1iSt)14 仪器校准计划(InStrUmentCa1ibrationPIan)15 仪器校准记录(InStrUmentCa1ibratiOnreCord)15.1 外校报告(ForeignSChoOIrePOrt)yes15.2 内校人员资格证书(Qua1ificationcertificateofinterna1schoo1personne1)15.3 内校规程(Interna1ca1ibrationprocedures)15.4 内校报告(Interna1ca1ibrationreport)16 年度培训计划(Annua1trainingp1an)17 培训记录(TrainingreCordS)17.1 签到表(Signinform)17.2 测试卷(TeStVOIUme)18 品管人员岗前资质认定资料(培训及测试记录)Prejobqua1ificationidentificationdataofqua1itycontro1personne1(trainingandtestrecords)19 新产品开发资料(NeWProdUCtdeVe1oPmentmateria1S)19.1 产品规格书(Productspecifications)19.2 BoM表(BOMsurface)19.3 安规认证证书(SafetyCertifiCate)19.4 样品检测报告(SamPIeteStrePOrt)19.5 试产记录(Tria1productionrecord)19.6 试产评估报告(Tria1productionevaIuationreport)19.7 作业指导书(OPeratiC)ninstructions)19.8 检验标准(Inspectionstandard)19.9 FMEA分析资料(FMEAana1ySiSdata)1.1 1产品质量控制计划(QC工程图)(Productqua1itycontro1p1an(QCengineeringdrawing)20 订单评审记录(OrderreVieWreCOrd)21 新供应商资格评定报告(NeWSUPPIierqua1ificationreport)22 现有供应商质量、交期、价格及服务定期评分表(RegU1arscoringtab1eforqua1ity,de1iverytime,priceandserviceofexistingsupp1iers)23 原材料采购订单(RaWmateriaIPUrChaSeorder)yes24 原材料规格承认书(Rawmateria1specificationacknow1edgment)25 进料检验作业指导书(InCOminginSPeCtiOnOPerationyesinstruction)27 进料检验样板清单及定期评估记录表(InCOminginspectionsamp1e1istandperiodiceva1uationrecordform)28 进料检验记录(InCOminginSPeCtionreCord)yes29 不合格来料处理记录(含供应商纠正预防措施报告)yes(Hand1ingrecordsofnonconformingincomingmateria1s(inc1udingthesupp1ier'scorrectiveandpreventivemeasuresreport)30 原材料保存周期规定(RegUIatiOnSonStorageCyCIeOfraWmateria1s)31 原材料过期重检记录(MateriaISPeriOdiCre-inspectionrecords)32 控制图表及超限处理记录(ContrOIChartandoVer1imithand1ingrecord)33 CPK应用指弓I(CPKUSageguide1ine)34 CPK测量记录及制程能力不足时的改进记录(CPKmeasurementrecordsandImprovementrecordsincaseofinsufficientprocesscapacity)35 生产作业指导书(PrOdUCtiOnoPerationinStrUCtiOn)36 制程检验作业指导书(ProCeSSinSPeCtionOPerationyesinstructions)37 制程检验标准(Pre)CeSSinSPeCtiOnStandard)yes38 制程检验记录(ProCeSSinSPeCtiOnreCordS)yes1.1 1首件记录表(FirStartiCIereCordfOrm)yes1.3 3抽检记录表(Samp1inginspectionrecordform)yes1.4 4尾检记录表(Fina1inspectionrecordform)39 制程不合格品的处理记录(含纠正预防措施报告)(Hand1ingrecordsofnonconformingproductsintheprocess(inc1udingcorrectiveandpreventivemeasuresreport)40 制程检验不良统计报表(月/周报、柏拉图)(StatiStiCa1reportofprocessinspectiondefects(month1y/week1yreport,P1ato)41 停线管理规定及记录(ManagementregU1atiOnSandrecordsof1inesuspension)42 成品作业指导书(FiniShedProdUCtOPerationinStrUCtion)43 成品检验标准(FiniShedProdUCtinSPeCtionStandard)44 成品检验记录(FiniShedProdUCtinSPeCtiOnreCord)45 不合格品处理记录(DiSPoSaIreCOrdOfnonCOnfOrmingproducts)45.1 返工、返修记录(ReWorkandrePairreCOrdS)45.2 重检记录(Reinspectionrecord)45.3 纠正预防措施报告(COrreCtiVeandPreVentiVeaCtiOnreport)46 成品入库单(FiniShedgOodSWarehoUSingorder)47 产品可靠性及环境测试计划及记录(Productre1iabi1ityandenvironmenta1testp1anandrecord)48 数据分析程序(Dataana1ySiSProgram)49 质量目标统计资料(QUa1ityObjeCtiVeStatiStiCS)50 客户沟通资料(CUStomerCOmmUniCationmateriaIS)51 客户投诉程序(CUStOmerCOmPIaintProCedUre)52 客户投诉处理记录(CUStOmerCOmPIainthand1ingreCOrd)