质量体系文件审核资料清单

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 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 examinationand 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 and services);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 supplier correctiveand 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 of control 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 (including correctiveand 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, Platofigure).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);。