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质量体系审核文件资料清单" g/ P1 x; X8 K5 S$ o: W9 d
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Documents List for QMS Audit l: ~3 J3 r& S
1. 营业执照 (Business Licenses);
4 B, {( W' i0 |1 K1 b4 Q2. 质量体系认证证书 (QMS certificate);1 O7 i( V- T k; i* {
3. 组织架构图 (Organization Chart);6 U) L, N; `! p, v' S
4. 质量手册 (Quality manual);
* z. K. y! J6 q: W% n5. 程序文件 (Quality procedure);
8 e8 F1 t9 {' R3 w6. 质量体系内审计划 (QMS internal audit plan);
, t2 [* E* e' z' _; [; m* N7. 质量体系内审记录 (QMS internal audit records):
% q1 F, ~5 D9 O# |1)内审员资格证书 (Internal auditor qualification certificate);' d% S) `" X, B {2 M' Q$ ]) C
2)首末次会议 (Opening meeting and close meeting records);
' t5 G0 V' T7 q8 C3)检查表 (QMS internal audit checklist);( T5 m( k9 U* E1 R6 ?* j9 ]
4)不符合项报告 (QMS internal audit NC reports);) U3 z* n. M5 m0 H+ ~/ E
5)内审报告 (QMS internal audit report)7 F* J, |3 |/ K+ p% N; n
8. 质量体系管理评审计划 (QMS management review plan)
3 n' q6 w$ n3 ]: m' b* A: m; o9. 质量体系管理评审记录 (QMS management review records):
+ g, y0 x9 h: z8 }' x- a1)管理评审会议记录 (QMS management review meeting record);
* z! ]! N' l6 @5 Y5 U2)管理评审报告 (QMS management review report);
5 K; u9 p/ H2 i( d5 k" H3 k! o0 l. I3)决议事项的跟进记录 (QMS management review decisions follow-up records)
" c% Z$ o6 d& r! A7 T) E/ Y0 l. s10. 主要生产设备清单 (Major production machinery list);: s' H/ G& c# a# f- U# w8 R) ^
11.设备保养计划 (Machinery maintenance schedule);& s# p; G/ x7 {- U5 h
12. 设备保养记录 (Machinery maintenance records);
/ v; s: |0 f, \; H0 b13. 仪器清单 (Test and measure equipment list);
1 \; j0 c" }* [8 O2 m6 P8 `6 g7 U14. 仪器校准计划 (Test and measure equipment calibration schedule);7 I4 X# ]( |" o$ V7 [ S8 ^* a- ]' C
15. 仪器校准记录 (Test and measure equipment calibration records):
! f( x( ^! M6 _9 S' j, ]1)外校报告 (External calibration reports);
2 u9 |8 g. v- F H" \% k2)内校人员资格证书 (Internal calibration personnel qualification)
1 u0 [$ H s' C5 ?3)内校规程 (Internal calibration instruction);
' @9 ]$ h/ G3 ]/ a4 t4)内校报告 (Internal calibration reports
4 G; b, Y4 Z# M5 T. t: Z# ^16. 年度培训计划 (Annual training plan)& M, U- q, ~4 t. c+ W O
17. 培训记录 (Training records):3 F2 x i' B6 H5 ?" d
1) 签到表 (Training attendee signature);# E9 `2 u, @2 |1 O S
2)测试卷 (Training effectiveness verification records
! s. N! T( L) N4 _! w2 V i- Q( v; N9 v18. 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);
& [/ r/ [5 W' O1 Z- F* W19. 新产品设计开发资料 (New products design and development records):1 m. Z4 l1 T& [, r) j
1)产品规格书 (Product specification);" _$ I |- @* X0 M$ O# ]
2) BOM表 (BOM);3 I' b: F$ _) H; R- {* @
3)安规认证证书 (Safety certificate);
1 ~+ g8 y7 ]% p- Y" |+ E$ M4)样品检测报告 (Design samples test and inspection reports)
0 j" @: q1 v9 y3 i+ ~+ F8 F5)试产记录 (Pilot runs record);
, C0 R# w8 i+ x- N% I- u7 m0 L6) 试产评估报告 (Pilot runs review records);; j# v$ u E5 d3 X
7) 作业指导书 (Work instruction);( o$ }5 C& X0 |- W8 X" w( [1 V
8)检验标准 (Inspection standard);
7 A7 }8 E1 ]% J, {' U- O2 k, J9) FMEA分析资料 (FMEA analysis report);& _' \1 N) s. ~
10)产品质量控制计划(QC工程图)-Product quality control plan/chart.
1 g, L/ I- a" F20. 订单评审记录 (Order review records);5 f! X. ]8 Q, e, k
21. 新供应商资格评定报告 (New suppliers evaluation reports)
+ M9 i& Y/ W+ \/ J22. 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);/ N% Q9 c- _, m' U2 ?: e4 z
23. 原材料采购订单 (Materials purchasing order);
! d* H; \& Z; k: s24. 原材料规格承认书 (Materials specifications)* `# Y( Y' i+ E$ c6 E6 L
25. 进料检验作业指导书 (incoming inspection procedure/instructions);9 G( F- b) t1 A) P1 }! a! ^
26. 进料检验标准 (Incoming inspection standards);" Z+ j9 r/ _& `
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);
2 P9 S) `( b' l) O9 H* @( d28. 进料检验记录 (Incoming inspection records);
8 F" l3 G2 H2 {" ?. j/ T29. 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);" Y3 Q9 w! [2 V. U& c
30. 原材料保存周期规定 (Materials storage period instruction);0 C3 O7 n S$ c$ G) u9 Y9 c, J
31. 原材料过期重检记录 (Materials periodic re-inspection records);
9 [* _ u2 W3 I* E9 n32. 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);
- }: P* C/ J! U+ e, y) [/ s33. CPK应用指引 (CPK usage guideline);; E6 P% S6 Y4 I
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);
: n# Y! a. g+ d5 r* L7 E1 Z35. 生产作业指导书 (Work instruction);
: O. W1 Z! J, q* {4 I36. 制程检验作业指导书 (In-process inspection procedure/instruction);
/ \$ k" x+ O! h9 H$ o" m37. 制程检验标准 (In-process inspection standards);% m4 i; F$ s8 F) }' k: i4 m6 Z; \ m. Y
38. 制程检验记录 (In-process inspection records):& j- }3 V0 N* M, A3 ~ `
1)首件检验记录 (First article inspection reports);' B g7 v8 a# S
2)巡检记录 (Production line tour inspection records);7 r" E! |) }4 q' U( \% ]
3)抽检记录 (Sampling inspection records)4 G% n* l L& a9 {+ V/ T0 @
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);
) w ^6 f+ n0 D7 c( `* Q40. 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
) F/ ~* f4 }( ?8 N41. 停线管理规定及记录 (Production stop procedure and records);
' v, I- \ r% ~: Z3 v42. 成品检验作业指导书 (Final inspection procedure/instruction);6 r S9 u7 h! i+ G/ n8 r$ P" {6 F
43. 成品检验标准 (Final inspection standards);8 R. C6 V' @7 b* ]1 u5 y
44. 成品检验记录 (Final inspection records);& P. I1 d1 b) x: v0 F7 i9 S4 _
45. 不合格成品处理记录 (Non-conforming products handling records):
" Q6 `9 Y. Y7 i2 M% D8 s. _( m1)返工、返修记录 (Rework, repair records);
+ _6 w' D, ~" u, w( B2 N7 o2)重检记录 (Re-inspection records)
+ A7 F8 U) D" G3) 纠正预防措施报告 (Corrective and preventive actions report
7 C l7 f. Y- X) Q9 w7 j46. 成品入库单 (Finished products warehouse-in records);
/ b- C3 G& ^( b5 b3 l& M47. 产品可靠性及环境测试计划及记录 (Products reliability and environmental test plan/schedule and records);, V m, ~" a% H
48. 数据分析程序 (Data analysis procedure);
% P/ q0 S6 Z* l0 l49. 质量目标统计资料 (Data analysis records-mainly focus on quality objectives analysis records P+ o1 ] l3 q+ I3 v, `
50. 客户沟通资料 (Customer communication records);
4 w# e$ j5 o) s$ f2 V5 }- {51. 客户投诉处理程序 (Customer complaints procedure);
* L* L4 W, Q* m C' M1 R0 b52. 客户投诉处理记录 (Customer complaints handling reports) |
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