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1、IS09001质量体系审核文件资料清单9001质量体系审核文件资料清单是否拥有1营业执照(Businesslicense)yes2质量体系认证证书(Qualitysystemcertificate)yes3组织架构图(Organizationchart)yes4质量手册(Qualitymanual)yes5程序文件(Proceduredocuments)yes6质量体系内审计划(QMSinternalauditplan)7质量体系内审记录(InternaIauditrecordsofqualitysystem)1.1内审员资格证书(Internalauditorqualificationcer
2、tificate)yes7.2首末次会议(Firstandlastmeeting)7.3检查表(Checklist)7.4不符合项报告(Nonconformancereport)7.5内审报告(Internalauditreport)8质量体系管理评审计划(QUalitysystemmanagementreviewplan)9质量体系管理评审记录(Qualitysystemmanagementreviewrecords)9.1管理评审会议记录(Minutesofmanagementreviewmeeting)9.2管理评审报告(ManagementReviewReport)9.3决议事项的跟进
3、记录(Followuprecordofresolutions)10主要生产设备清单(Listofmainproductionequipment)11设备保养计划(Equipmentmaintenanceplan)12设备保养记录(Equipmentmaintenancerecords)13仪器清单(Instrumentlist)14仪器校准计划(InStrUmentcalibrationplan)15仪器校准记录(InStrUmentcalibrationrecord)15.1外校报告(Foreignschoolreport)yes15.2内校人员资格证书(Qualificationcerti
4、ficateofinternalschoolpersonnel)15.3内校规程(Internalcalibrationprocedures)15.4内校报告(Internalcalibrationreport)16年度培训计划(Annualtrainingplan)17培训I记录(Trainingrecords)17.1签到表(Signinform)17.2测试卷(Testvolume)18品管人员岗前资质认定资料(培训及测试记录)Prejobqualificationidentificationdataofqualitycontrolpersonnel(trainingandtestrec
5、ords)19新产品开发资料(Newproductdevelopmentmaterials)19.1产品规格书(Productspecifications)19.2BOM表(BOMsurface)19.3安规认证证书(Safetycertificate)19.4样品检测报告(Sampletestreport)19.试产记录(Trialproductionrecord)519.6试产评估报告(Trialproductionevaluationreport)19.7作业指导书(Operationinstructions)19.8检验标准(Inspectionstandard)19.9FMEA分析资
6、料(FMEAanalysisdata)19.1产品质量控制计划(QC工程图)(Productqualitycontrolplan(QCengineeringdrawing)20订单评审记录(Orderreviewrecord)21新供应商资格评定报告(Newsupplierqualificationreport)22现有供应商质量、交期、价格及服务定期评分表(RegUIarscoringtableforquality,deliverytime,priceandserviceofexistingsuppliers)23原材料采购订单(RaWmateriaIpurchaseorder)yes24原
7、材料规格承认书(Rawmaterialspecificationacknowledgment)25进料检验作业指导书(Incominginspectionoperationinstruction)yes26进料检验标准(Incominginspectionstandard)yes27进料检验样板清单及定期评估记录表(InCominginspectionsampIelistandperiodicevaluationrecordform)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)(Handlingrecordsofn
8、onconformingincomingmaterials(includingthesupplier,scorrectiveandpreventivemeasuresreport)yes30原材料保存周期规定(Regulationsonstoragecycleofrawmaterials)31原材料过期重检记录(Materialsperiodicre-inspectionrecords)32控制图表及超限处理记录(Controlchartandoverlimithandlingrecord)33CPK应用指引(CPKusageguideline)34CPK测量记录及制程能力不足时的改进记录(C
9、PKmeasurementrecordsandimprovementrecordsincaseofinsufficientprocesscapacity)35生产作业指导书(Productionoperationinstruction)36制程检验作业指导书(Processinspectionoperationinstruct!ons)yes37制程检验标准(Processinspectionstandard)yes38制程检验记录(Processinspectionrecords)yes38.1首件记录表(Firstarticlerecordform)yes38.2巡检记录表(Patroli
10、nspectionrecordform)yes38.3抽检记录表(Samplinginspectionrecordform)yes38.4尾检记录表(Finalinspectionrecordform)39制程不合格品的处理记录(含纠正预防措施报告)(HandIingrecordsofnonconformingproductsintheprocess(includingcorrectiveandpreventivemeasuresreport)40制程检验不良统计报表(月/周报、柏拉图)(Statisticalreportofprocessinspectiondefects(monthly/w
11、eeklyreport,Plato)41停线管理规定及记录(ManageInentregulationsandrecordsoflinesuspension)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
12、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(ProductreliabilityandenVironmentaltestplanandrecord)48数据分析程序(Dataanalysisprogram)49质量目标统计资料(Qualityobjectivestatistics)50客户沟通资料(Customercommunicationmaterials)51客户投诉程序(Customercomplaintprocedure)52客户投诉处理记录(Customercomplainthandlingrecord)
