上海m6米乐检针仪器有限公司

 

质量系统考核文件材料清单(Documents List for QMS Audit)

1.        业务执照 (Business Licenses);

2.        质量系统认证证书 (QMS certificate);

3.        构造架构图 (Organization Chart);

4.        质量手册 (Quality manual);

5.        步伐文件 (Quality procedure);

6.        质量系统内审方案 (QMS internal audit plan);

7.        质量系统内审记载 (QMS internal audit records):

1）        内审员资历证书 (Internal auditor qualification certificate);

2）        首末次集会 (Opening meeting and close meeting records);

3）        反省表 (QMS internal audit checklist);

4）        不切合项陈诉 (QMS internal audit NC reports);

5）        内审陈诉 (QMS internal audit report)

8.        质量系统办理评审方案 (QMS management review plan)

9.        质量系统办理评审记载 (QMS management review records):

1）        办理评审集会记载 (QMS management review meeting record);

2）        办理评审陈诉 (QMS management review report);

3）        决定事变的跟进记载 (QMS management review decisions follow-up records)

10.        次要消费设置装备摆设清单 (Major production machinery list);

11.        设置装备摆设调养方案 (Machinery maintenance schedule);

12.        设置装备摆设调养记载 (Machinery maintenance records);

13.        仪器清单 (Test and measure equipment list);

14.        仪器校准方案 (Test and measure equipment calibration schedule);

15.        仪器校准记载 (Test and measure equipment calibration records):

1）        外校陈诉 (External calibration reports);

2）        内校职员资历证书 (Internal calibration personnel qualification)

3）        内校规程 (Internal calibration instruction);

4）        内校陈诉 (Internal calibration reports

16.        年度培训方案 (Annual training plan)

17.        培训记载 (Training records):

1）        签到表 (Training attendee signature);

2）        测试卷 (Training effectiveness verification records

18.        品管职员岗前资质认定材料（培训及测试记载）-Quality personnel certification records (including training and examination records);

19.        新产品设计开辟材料 (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）        样品检测陈诉 (Design samples test and inspection reports)

5）        试产记载 (Pilot runs record);

6）        试产评价陈诉 (Pilot runs review records);

7）        作业引导书 (Work instruction);

8）        查验尺度 (Inspection standard);

9）        FMEA剖析材料 (FMEA analysis report);

10）        产品格量控制方案（QC工程图）-Product quality control plan/chart.

20.        订单评审记载 (Order review records);

21.        新供给商资历评定陈诉 (New suppliers evaluation reports)

22.        现有供给商质量、交期、代价及办事活期评分表 (Suppliers performance rating score in quality, delivery, price and services);

23.        原质料推销订单 (Materials purchasing order);

24.        原质料规格供认书 (Materials specifications)

25.        进料查验作业引导书 (incoming inspection procedure/instructions);

26.        进料查验尺度 (Incoming inspection standards);

27.        进料查验样板清单及活期评价记载 (Incoming inspection samples list and its periodic review records);

28.        进料查验记载 (Incoming inspection records);

29.        分歧格来料处置记载（含供给商改正防备步伐陈诉）-Non-conforming materials handling records (including supplier corrective and preventive reports);

30.        原质料保管周期划定 (Materials storage period instruction);

31.        原质料过时重检记载 (Materials periodic re-inspection records);

32.        控制图表及超限处置记载 (Control charts and corrective and preventive records for the process/products out of control limit);

33.        CPK使用指引 (CPK usage guideline);

34.        CPK丈量记载及制程才能不敷时的改良记载 (The improvement actions for the incapable process);

35.        消费作业引导书 (Work instruction);

36.        制程查验作业引导书 (In-process inspection procedure/instruction);

37.        制程查验尺度 (In-process inspection standards);

38.        制程查验记载 (In-process inspection records):

1）        首件查验记载 (First article inspection reports);

2）        巡检记载 (Production line tour inspection records);

3）        抽检记载 (Sampling inspection records)

39.        制程分歧格品的处置记载（含改正防备步伐陈诉）-In-process non-conforming products handling records (including corrective and preventive actions report);

40.        制程查验不良统计报表（周报/月报，柏拉图）-In-process inspection defects analysis report (weekly/monthly report, Plato figure

41.        停线办理划定及记载 (Production stop procedure and records);

42.        制品查验作业引导书 (Final inspection procedure/instruction);

43.        制品查验尺度 (Final inspection standards);

44.        制品查验记载 (Final inspection records);

45.        分歧格制品处置记载 (Non-conforming products handling records):

1）        返工、返修记载 (Rework, repair records);

2）        重检记载 (Re-inspection records)

3）        改正防备步伐陈诉 (Corrective and preventive actions report

46.        制品入库单 (Finished products warehouse-in records);

47.        产品牢靠性及情况测试方案及记载 (Products reliability and environmental test plan/schedule   and records);

48.        数据剖析步伐 (Data analysis procedure);

49.        质量目的统计材料 (Data analysis records-mainly focus on quality objectives analysis records

50.        客户相同材料 (Customer communication records);

51.        客户赞扬处置步伐 (Customer complaints procedure);

52.        客户赞扬处置记载 (Customer complaints handling reports)

 

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