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 certificate);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 record）；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 follow—up 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 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（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）；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.20. 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/instructions);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）-Non—conforming materials handling records （including suppliercorrective and preventive reports）；30. 原材料保存周期规定（Materials storage period instruction）;31. 原材料过期重检记录（Materials periodic re—inspection 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. C PK应用指引（C PK usage guideline）;34. C PK测量记录及制程能力不足时的改进记录（The improvement actions for the incapable process）;35. 生产作业指导书(Work instruction)；36. 制程检验作业指导书（In—process inspection procedure/instruction)；37. 制程检验标准(In—process 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 inspection records)39. 制程不合格品的处理记录（含纠正预防措施报告）-In—process 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 records);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(Re—inspection records)3）纠正预防措施报告(Corrective and preventive actions report).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）.。