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 Audit

1. 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 and

examination 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

corrective 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 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

corrective 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).