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质量体系审核文件资料清单6 M0 d* {3 r" A n
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Documents List for QMS Audit
- }& p4 L7 x0 @ q: b- n& e1. 营业执照 (Business Licenses);4 x: M" D9 e1 o, V
2. 质量体系认证证书 (QMS certificate);
- w) i: P2 A1 q7 x# L) F3. 组织架构图 (Organization Chart);* D5 S. D$ A/ u. j! L% k
4. 质量手册 (Quality manual);, u! z. B5 d* F. K; [
5. 程序文件 (Quality procedure); J: c! N( x1 l% N
6. 质量体系内审计划 (QMS internal audit plan);
7 U* N! ]( C$ ~1 _" R+ e# g7. 质量体系内审记录 (QMS internal audit records):
# B+ v& l: ?3 S5 v( m l0 d1)内审员资格证书 (Internal auditor qualification certificate);. j0 V: Y4 P- p) o) S( y1 V5 H
2)首末次会议 (Opening meeting and close meeting records);
c" u0 [" S/ y2 h& d( ^0 \3)检查表 (QMS internal audit checklist);! x7 p7 m1 h2 c* I$ p0 `- X
4)不符合项报告 (QMS internal audit NC reports);! J$ J/ a* D+ @1 e- K i' g
5)内审报告 (QMS internal audit report)
9 W+ r* a, H, C* O! E, A( A; A. ?; q% Q8. 质量体系管理评审计划 (QMS management review plan)8 J( M+ e# i9 ]: Z: w
9. 质量体系管理评审记录 (QMS management review records):
7 t+ f9 e! g6 J4 H( M3 i1)管理评审会议记录 (QMS management review meeting record);
5 ]% P, i% f* \' g! x2)管理评审报告 (QMS management review report);
% o* L" z: \! Z3)决议事项的跟进记录 (QMS management review decisions follow-up records)
# g. V; z/ p3 Q10. 主要生产设备清单 (Major production machinery list);; m% W: W" W* }( w# N# s& F
11.设备保养计划 (Machinery maintenance schedule);. P% D3 J, w0 K8 m# h
12. 设备保养记录 (Machinery maintenance records);
( e G( S( j' O8 M, T& P7 M! M# Y13. 仪器清单 (Test and measure equipment list); x1 D" }: I# ]* \, f- B' E2 h
14. 仪器校准计划 (Test and measure equipment calibration schedule);8 O: E! \) Z3 S
15. 仪器校准记录 (Test and measure equipment calibration records):
+ `7 `: p- \' V+ C' o- v1)外校报告 (External calibration reports);5 k# C# Z( Q( g7 m
2)内校人员资格证书 (Internal calibration personnel qualification). x) I7 \4 U1 ?$ X
3)内校规程 (Internal calibration instruction);2 F+ n: _. r8 h# G: t. E8 ]0 b; G
4)内校报告 (Internal calibration reports
4 X* ^9 g6 e- Z- t' T0 J16. 年度培训计划 (Annual training plan); Q' `( Y+ F# D2 [
17. 培训记录 (Training records):5 z# H5 R# ]/ V
1) 签到表 (Training attendee signature);
- R9 T! O2 n7 M8 F! F; O9 z" Q) ]2)测试卷 (Training effectiveness verification records$ C( M0 z* C3 O* s" X
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);
3 l6 M/ U$ [$ m) i; t# x19. 新产品设计开发资料 (New products design and development records):
4 g1 n5 A% B% p8 L: O- M5 s2 t1)产品规格书 (Product specification);
( q1 {4 v+ g+ G3 f: e& z2) BOM表 (BOM);
! U, ~' G, ~6 a% `: V3)安规认证证书 (Safety certificate);
8 F) D k0 R) q6 U4)样品检测报告 (Design samples test and inspection reports)6 _5 I. _; e9 \* A5 O4 e% Y" a/ `
5)试产记录 (Pilot runs record);
" E7 _- ^$ N; I- p6) 试产评估报告 (Pilot runs review records);# ?6 `% e! s6 p
7) 作业指导书 (Work instruction);
9 z* Z# ^$ [2 R8)检验标准 (Inspection standard);
5 W% P* R3 D" S/ g A9) FMEA分析资料 (FMEA analysis report);3 X, v7 @( y a9 r
10)产品质量控制计划(QC工程图)-Product quality control plan/chart.$ }$ i" o' N# N! H* C T3 E
20. 订单评审记录 (Order review records);. D N3 Z; M9 G; ~
21. 新供应商资格评定报告 (New suppliers evaluation reports)
& f9 ]0 ^* }. r8 R" H4 d @7 V: e3 {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);: _7 w" z7 _4 f* u. {
23. 原材料采购订单 (Materials purchasing order);) C/ o4 R+ k1 H
24. 原材料规格承认书 (Materials specifications)
2 L& b1 J H$ w4 t& G25. 进料检验作业指导书 (incoming inspection procedure/instructions);' V: p+ Q5 |% m& d- ^ B1 ^, x
26. 进料检验标准 (Incoming inspection standards);; [" F( Z' \+ H% Z" I
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);
/ _0 t# J9 V f3 o# \1 L: i4 e2 D28. 进料检验记录 (Incoming inspection records);$ W1 k& X$ s4 M
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);
& t. ^9 [3 Q) W) J30. 原材料保存周期规定 (Materials storage period instruction);
1 _% J; L1 C1 S7 i4 K5 v" [0 r! W31. 原材料过期重检记录 (Materials periodic re-inspection records);7 t" l% h# t/ u
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);) s0 J; N8 ?* i: ~+ e8 R
33. CPK应用指引 (CPK usage guideline);8 c, b" c0 S( f T, _2 D, c, b
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);
9 x7 _* A% U' i& z! m: h35. 生产作业指导书 (Work instruction);
9 i D4 z2 \! K1 ~# m* W& Q% R. X36. 制程检验作业指导书 (In-process inspection procedure/instruction);/ {4 S- e1 q2 p+ y! J9 z
37. 制程检验标准 (In-process inspection standards);
; q, V3 K N' v38. 制程检验记录 (In-process inspection records):
1 T4 Z i+ O% Z7 K1)首件检验记录 (First article inspection reports);
4 ?# K8 V7 K( V4 z" O8 U1 u0 ~2)巡检记录 (Production line tour inspection records);
, t9 U- r- ]3 w/ ]4 E. U3)抽检记录 (Sampling inspection records)
$ l; f: Q- X! B) C+ n39. 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);' B- x, Q2 }. q$ D8 v3 c! l& }$ z
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
( H" Q# ~# N# T: M41. 停线管理规定及记录 (Production stop procedure and records);
6 h- {/ f) j! i1 Z2 j$ I! M3 Y$ k42. 成品检验作业指导书 (Final inspection procedure/instruction);
/ u/ C" Z+ {8 [0 z. p0 J43. 成品检验标准 (Final inspection standards);
" d& s9 C9 t' j' N4 x$ P2 U3 N44. 成品检验记录 (Final inspection records);2 z8 M0 [ B9 U( E6 H7 J: [
45. 不合格成品处理记录 (Non-conforming products handling records):; K" p+ m0 P/ a$ t, T* j
1)返工、返修记录 (Rework, repair records);
- W z$ ^- P& S! x8 w2)重检记录 (Re-inspection records)
+ ?5 _1 C- n; l5 V3) 纠正预防措施报告 (Corrective and preventive actions report
" g& T3 W* Q8 i" d/ c2 d46. 成品入库单 (Finished products warehouse-in records);
" Z( ]0 Q2 y- J: O! B8 X6 i47. 产品可靠性及环境测试计划及记录 (Products reliability and environmental test plan/schedule and records);
7 B& s1 t$ i1 {48. 数据分析程序 (Data analysis procedure);0 r2 a6 C" ` g- k' I1 L+ }
49. 质量目标统计资料 (Data analysis records-mainly focus on quality objectives analysis records7 `2 A K6 F: ^6 V! n; j
50. 客户沟通资料 (Customer communication records);
: s% H1 ?3 r v4 N! M51. 客户投诉处理程序 (Customer complaints procedure);
! l A! E1 A& A& H& q5 p52. 客户投诉处理记录 (Customer complaints handling reports) |
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