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质量体系审核文件资料清单6 s/ j, Y! K, y- \; g: |2 ^. z5 m
2 { ]/ q6 L/ Q, | Q. [Documents List for QMS Audit/ Y' {* u0 @# k7 r- _0 j
1. 营业执照 (Business Licenses);
3 c8 I9 Y' v- R3 F; B6 q, G2. 质量体系认证证书 (QMS certificate);
' s' J$ Q* i& i/ j- } L3. 组织架构图 (Organization Chart);
! W" g( d- j2 u: C! G# x4. 质量手册 (Quality manual);
7 \# Q0 n- P6 e' }+ K9 J4 T& b5. 程序文件 (Quality procedure);; \4 a% M- a/ t5 A& J) r
6. 质量体系内审计划 (QMS internal audit plan);! @" K4 o0 m# ^% O* i
7. 质量体系内审记录 (QMS internal audit records):
9 P( H9 z0 F2 _1 K0 s# d1)内审员资格证书 (Internal auditor qualification certificate);
2 d) F w4 y7 Y# M& M4 H$ k2)首末次会议 (Opening meeting and close meeting records);& z, i! o# ?/ Y% D4 t
3)检查表 (QMS internal audit checklist);: w9 I9 D) p7 [6 m( ?6 Y& A
4)不符合项报告 (QMS internal audit NC reports);/ V! P( Q4 H% @+ n
5)内审报告 (QMS internal audit report)
1 R8 u/ o9 j5 ^, w/ u, R8. 质量体系管理评审计划 (QMS management review plan)$ U, T' W8 {& I! Z6 q6 @- q9 Z
9. 质量体系管理评审记录 (QMS management review records):
( l" w7 s$ e7 b. P# ?2 ]0 _" ]1)管理评审会议记录 (QMS management review meeting record);3 p& t6 A( y) R
2)管理评审报告 (QMS management review report);
& b: N/ a0 F8 h, K* r3)决议事项的跟进记录 (QMS management review decisions follow-up records)
3 ^, p! E$ w Z10. 主要生产设备清单 (Major production machinery list);$ T. e8 |/ ^$ o% o
11.设备保养计划 (Machinery maintenance schedule);
* X, B, b3 K" k* {& O f3 z2 W12. 设备保养记录 (Machinery maintenance records);
8 A) [5 P+ [ H13. 仪器清单 (Test and measure equipment list);/ c" [% g9 t7 A3 `
14. 仪器校准计划 (Test and measure equipment calibration schedule);) D0 d3 r( C! E1 Y) r
15. 仪器校准记录 (Test and measure equipment calibration records):
$ A' D* u7 A' r# x4 G! V1)外校报告 (External calibration reports);& R8 j1 X' l( H" v# L
2)内校人员资格证书 (Internal calibration personnel qualification). D8 O% b6 p1 p3 i/ ?
3)内校规程 (Internal calibration instruction);9 Z+ M" r) w( j3 ?
4)内校报告 (Internal calibration reports3 f$ D9 r) x" i5 L' J: }9 [2 M9 K
16. 年度培训计划 (Annual training plan)' T7 G' {3 d0 d6 S
17. 培训记录 (Training records):
, ]# {0 `3 E. f& }$ w1) 签到表 (Training attendee signature);/ ]4 G: u k1 X9 B) R9 L
2)测试卷 (Training effectiveness verification records6 D+ X6 c. M9 }+ e( m4 h
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);% Z9 R- }) R: z
19. 新产品设计开发资料 (New products design and development records):& u4 w* c9 |3 \; x& N
1)产品规格书 (Product specification);
# ^ u/ J' @8 C* `7 w8 \2) BOM表 (BOM);
d5 F, d- U$ f ]3)安规认证证书 (Safety certificate);
4 r2 K, \ @! p. c) F2 s4)样品检测报告 (Design samples test and inspection reports)
% E' F* d/ U$ Z; t- p# Z5)试产记录 (Pilot runs record);& i$ l7 u2 o0 f
6) 试产评估报告 (Pilot runs review records);) m0 f6 S0 F$ f! s* Y& A) T
7) 作业指导书 (Work instruction);
/ }1 H% T. U2 F( O, ?9 P8)检验标准 (Inspection standard);
/ }$ ]/ u& x" P& H9) FMEA分析资料 (FMEA analysis report);
}# w9 y0 |. t+ m% P) q; {" `* P10)产品质量控制计划(QC工程图)-Product quality control plan/chart.; N A. D. m# m6 S; Q: S7 {
20. 订单评审记录 (Order review records);
0 X- D" k, `0 z" _; j2 a! B2 o) h0 Q8 K21. 新供应商资格评定报告 (New suppliers evaluation reports)
. r6 o3 Z, ^4 m/ v+ ?# p22. 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);
2 e2 S7 c& A- Q: H6 `/ J9 T23. 原材料采购订单 (Materials purchasing order);; d- p+ s1 u0 w% m8 u( d/ Y5 f
24. 原材料规格承认书 (Materials specifications)
9 w1 j0 @; Z7 [- Q. U! I25. 进料检验作业指导书 (incoming inspection procedure/instructions);
1 \! y T# h4 s, ]$ z' [4 L26. 进料检验标准 (Incoming inspection standards);& k4 `2 m4 E$ D$ v
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);% I3 V5 j0 E! o* o
28. 进料检验记录 (Incoming inspection records);
4 S5 e) d9 S% [- F9 M29. 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);
; S2 X2 R% z0 }3 ?& x0 Q30. 原材料保存周期规定 (Materials storage period instruction);( G# X$ H) ~' I# A0 G! O, r
31. 原材料过期重检记录 (Materials periodic re-inspection records);; I0 m) ~/ S# W; y# E4 p
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);
* v& {& [1 b/ s) a2 \$ {33. CPK应用指引 (CPK usage guideline);2 {2 j( W# d9 Y1 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);
8 `# T' ^( r3 S: [% ~# c) C5 r35. 生产作业指导书 (Work instruction);0 c% @+ ^! u# ~2 S
36. 制程检验作业指导书 (In-process inspection procedure/instruction);
7 @* S# k4 Y" f* E, F37. 制程检验标准 (In-process inspection standards); M4 b3 @/ f, A' e. W" Y6 s V
38. 制程检验记录 (In-process inspection records):
) Z3 j# Z+ f* A9 ^% N5 w4 S' F7 w1)首件检验记录 (First article inspection reports);0 \" f& Y( [, T6 ^/ b
2)巡检记录 (Production line tour inspection records);
/ @" v3 X/ U6 \" C; P3)抽检记录 (Sampling inspection records)
, Y" ?7 u0 ?7 L$ O* q5 Y+ o39. 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);
- z6 L% `8 t# ]0 Z# S' U40. 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
i" q$ T# U3 p. j( z6 i41. 停线管理规定及记录 (Production stop procedure and records);
8 n! f8 B# h& ~& Z+ T1 }# q42. 成品检验作业指导书 (Final inspection procedure/instruction);
6 M! u! V4 [" ~# l' B* L43. 成品检验标准 (Final inspection standards);
7 `/ B# C# J( Y* }0 j/ a44. 成品检验记录 (Final inspection records);
2 }# g# s& C# W4 N9 B5 W! V7 _* G45. 不合格成品处理记录 (Non-conforming products handling records):
- H' B/ p2 |1 ^8 I. ~1)返工、返修记录 (Rework, repair records);
4 O; j7 J9 e4 S6 U& t+ y3 \2)重检记录 (Re-inspection records), } ~& k2 e O8 {0 a
3) 纠正预防措施报告 (Corrective and preventive actions report1 a: w. u) `9 X
46. 成品入库单 (Finished products warehouse-in records);4 k8 A/ C8 R" b
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);
, ~+ [+ F! ^7 _! |+ a48. 数据分析程序 (Data analysis procedure);5 n9 _5 Y$ ~9 \4 Z; ?
49. 质量目标统计资料 (Data analysis records-mainly focus on quality objectives analysis records& l7 m& R' Z% {* L/ K6 g/ e# o. o1 Q# t
50. 客户沟通资料 (Customer communication records);
2 ]: h1 h- e* T1 K9 x51. 客户投诉处理程序 (Customer complaints procedure);- z5 g4 _( W' V
52. 客户投诉处理记录 (Customer complaints handling reports) |
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