Documents List for QMS Audit(质量体系审核文件资料清单)

hung

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);

charlesdm

Thanks,辛苦发贴，再接再励

lzt4761

very useful, thank you

狼猫

很详细，谢谢

cubrd

very very good files,thanks for your sharing

francez06

是一套很好的文件，要是能有详细的介绍就更好了

kevin_6888

moderator,if you provide the details of documents or procedures listed on QMS audit list,which will be appreciated

kingso

very good files,thanks for your sharing

hung

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)

hung

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.  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 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