ISO9001质量体系审核文件资料清单全套中英文对照表.docx

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1、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(BUSineSS1icense)yes2质量体系认证证书(QUa1itysystemcertificate)yes3组织架构图(Organizationchart)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，己录(Interna1auditrecordsofqua1itysystem)7.1内审员资格证书(Interna1auditorqua1ificationcertificate)ye

2、s7.2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(QUaIitySyStemmanagementreviewp1an)9质量体系管理评审记录(QUaIitysystemmanagementreviewrecords)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(Fo11ow

3、uprecordofreso1utions)10 主要生产设备清单(1iStofmainproductionequipment)11 设备保养计戈11(Equipmentmaintenancep1an)12 设备保养记录(Equipmentmaintenancerecords)13 仪器清单(InStrUment1iSt)14 仪器校准计划(Instrumentca1ibrationp1an)15 仪器校准记录(Instrumentca1ibrationrecord)15.1 夕卜校报告(Foreignschoo1report)yes15.2 内校人员资格证书(Qua1ificationcer

4、tificateofinterna1schoo1personne1)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(Testvo1ume)18 品管人员岗前资质认定资料(培训及测试记录)Prejobqua1ificationidentificationdataofqua1itycontro1personne1(trainingan

5、dtestrecords)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(Samp1etestreport)19.5 试产t己录(Tria1productionrecord)19.6 试产评估报告(Tria1productioneva1uationreport)19.7 作业指导书(Operationinstructions)19.8 检验标准(Inspectionst

6、andard)19.9 FMEA分析资料(FMEAana1ySiSdata)1.1 1产品质量控制计划(QC工程图)(PrOdUCtqUaIityCOntro1p1an(QCengineeringdrawing)20 订单评审记录(OrderreVieWreeOrd)21 新供应商资格评定报告(NeWsupp1ierqua1ificationreport)22 现有供应商质量、交期、价格及服务定期评分表(RegUIarscoringtab1eforqua1ity,de1iverytime,priceandserviceofexistingsupp1iers)23 原材料采购订单(RaWmate

7、ria1PUrChaSeorder)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(Hand1ingrecordsofnonconfo

8、rmingincomingmateria1s(inc1udingthesupp1ierscorrectiveandpreventivemeasuresreport)30 原材料保存周期规定(Regu1ationsonstoragecyc1eofrawmateria1s)31 原材料过期重检记录(Materia1SPeriOdiCre-inspectionrecords)32 控制图表及超限处理记录(ContrOIChartandOVerIimithand1ingrecord)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(CPKmea

9、surementrecordsandimprovementrecordsincaseofinsufficientprocesscapacity)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(PrOCeSSinSPeCtiOnStandard)yes38 制程检验记录(PrOCeSSinSPeCtiOnreCOrdS)yes1.1 1首件t己录表(Firstartic1erecordform)yes1.3 3抽检记录表(Samp1

10、inginspectionrecordform)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(Mana

11、gementregU1atiOnSandrecordsof1inesuspension)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(Disposa1recordofnonconformingproducts)45.1 返工、返修记录(ReWOrkandrePairreCordS)45.2 重检记录(ReinSPeCtionreCOrd)45.3 纠正预

12、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(QUaIityobjectivestatistics)50 客户沟通资料(Customercommunicationmateria1s)51 客户投诉程序(CUStOmercomp1aintprocedure)52 客户投诉处理记录(CUStomercomp1ainthand1ingrecord)