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1、质量体系审核文件资料清单质量体系审核文件资料清单Documents List for QMS Audit1.营业执照(Business Licenses）；2.质量体系认证证书(QMS certificate）;3.组织架构图（Organization Chart）；4.质量手册(Quality manual）;5.程序文件（Quality procedure);6.质量体系内审计划（QMS internal audit plan）;7.质量体系内审记录（QMS internal audit records）：1）内审员资格证书(Internal auditor qualification c
2、ertificate);2）首末次会议（Opening meeting and close meeting records）；3）检查表（QMS internal audit checklist）；4）不符合项报告（QMS internal audit NC reports）;5）内审报告(QMS internal audit report）8.质量体系管理评审计划（QMS management review plan）9.质量体系管理评审记录（QMS management review records）：1）管理评审会议记录(QMS management review meeting rec
3、ord）；2）管理评审报告(QMS management review report);3）决议事项的跟进记录（QMS management review decisions followup records)10.主要生产设备清单(Major production machinery list）；11.设备保养计划(Machinery maintenance schedule)；12.设备保养记录(Machinery maintenance records）;13.仪器清单(Test and measure equipment list）；14.仪器校准计划（Test and measure
4、 equipment calibration schedule);15.仪器校准记录（Test and measure equipment calibration records):1）外校报告(External calibration reports）;2）内校人员资格证书(Internal calibration personnel qualification）3）内校规程(Internal calibration instruction);4）内校报告（Internal calibration reports）.16.年度培训计划（Annual training plan）17.培训记录
5、（Training records）：1）签到表（Training attendee signature）;2）测试卷（Training effectiveness verification records）.18.品管人员岗前资质认定资料(培训及测试记录）Quality personnel certification records(including training andexamination records）;19.新产品设计开发资料（New products design and development records)：1）产品规格书（Product specification）
6、；2）BOM 表(BOM);3）安规认证证书(Safety certificate);4）样品检测报告（Design samples test and inspection reports）5）试产记录（Pilot runs record)；6）试产评估报告（Pilot runs review records）；7）作业指导书（Work instruction);8）检验标准（Inspection standard)；9）FMEA 分析资料（FMEA analysis report）;10）产品质量控制计划（QC 工程图）Product quality control plan/chart.2
7、0.订单评审记录（Order review records）；21.新供应商资格评定报告（New suppliers evaluation reports）22.现有供应商质量、交期、价格及服务定期评分表（Suppliers performance rating score in quality,delivery，price andservices）;23.原材料采购订单（Materials purchasing order）；24.原材料规格承认书(Materials specifications)25.进料检验作业指导书(incoming inspection procedure/inst
8、ructions);26.进料检验标准(Incoming inspection standards）;27.进料检验样板清单及定期评估记录（Incoming inspection samples list and its periodic review records);28.进料检验记录（Incoming inspection records）;29.不合格来料处理记录(含供应商纠正预防措施报告）-Nonconforming materials handling records（including suppliercorrective and preventive reports）；30.原
9、材料保存周期规定（Materials storage period instruction）;31.原材料过期重检记录（Materials periodic reinspection records)；32.控制图表及超限处理记录（Control charts and corrective and preventive records for the process/products out ofcontrol limit）;33.CPK应用指引（CPK usage guideline）;34.CPK测量记录及制程能力不足时的改进记录（The improvement actions for t
10、he incapable process）;35.生产作业指导书(Work instruction)；36.制程检验作业指导书（Inprocess inspection procedure/instruction)；37.制程检验标准(Inprocess inspection standards)；38.制程检验记录（In-process inspection records）:1）首件检验记录（First article inspection reports)；2）巡检记录（Production line tour inspection records）;3）抽检记录（Sampling in
11、spection records)39.制程不合格品的处理记录（含纠正预防措施报告）-Inprocess non-conforming products handling records（includingcorrective and preventive actions report);40.制程检验不良统计报表（周报/月报，柏拉图）-In-process inspection defects analysis report（weekly/monthly report，Plato figure）。41.停线管理规定及记录(Production stop procedure and recor
12、ds);42.成品检验作业指导书(Final inspection procedure/instruction);43.成品检验标准(Final inspection standards)；44.成品检验记录（Final inspection records);45.不合格成品处理记录（Non-conforming products handling records）:1）返工、返修记录（Rework，repair records)；2）重检记录(Reinspection records)3）纠正预防措施报告(Corrective and preventive actions report).
13、46.成品入库单(Finished products warehouse-in records）;47.产品可靠性及环境测试计划及记录(Products reliability and environmental test plan/schedule and records）;48.数据分析程序（Data analysis procedure）;49.质量目标统计资料（Data analysis records-mainly focus on quality objectives analysis records)。50.客户沟通资料（Customer communication records)；51.客户投诉处理程序（Customer complaints procedure）；52.客户投诉处理记录(Customer complaints handling reports）.