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质量体系审核文件资料清单6 N) b9 s4 o, M6 z W
( O5 s' ]! \& V" T! u" FDocuments List for QMS Audit: c. w; w4 ^, ^4 l% u" ~
1. 营业执照 (Business Licenses);
' h* {' z) F* D6 g) e* Y4 F. r0 b2. 质量体系认证证书 (QMS certificate); ^6 e- c# Y; W2 V- S3 f
3. 组织架构图 (Organization Chart);
1 h# s7 n& O6 L0 A: s4. 质量手册 (Quality manual);
7 ?8 A: r! ^' } X7 X5. 程序文件 (Quality procedure);: p5 R. v% |/ G
6. 质量体系内审计划 (QMS internal audit plan);' g0 \ O: I6 k/ Q7 {
7. 质量体系内审记录 (QMS internal audit records):
# h# _/ @( ]2 ^ b( p7 V1 `1)内审员资格证书 (Internal auditor qualification certificate);; d' a4 F! V2 \. k4 H, [
2)首末次会议 (Opening meeting and close meeting records);
6 p/ [: L$ O" `$ c# }3 B3)检查表 (QMS internal audit checklist);
" K. F- s. Q7 E. ?+ G: f9 l1 O; P' H4)不符合项报告 (QMS internal audit NC reports);- ]" _9 ?4 {; q* n ?
5)内审报告 (QMS internal audit report)
7 n& t, Y$ P4 N5 [8. 质量体系管理评审计划 (QMS management review plan)7 {# V( N' ^ v- a0 }
9. 质量体系管理评审记录 (QMS management review records):8 t& [- M& c! x7 ]/ O, N% X9 o" @- G8 r
1)管理评审会议记录 (QMS management review meeting record);
5 h# V- Q0 v6 E2)管理评审报告 (QMS management review report);
9 S `' O) j# j/ p( f; C" `# M; S3)决议事项的跟进记录 (QMS management review decisions follow-up records)5 X$ J* \/ @$ \) B; `3 r
10. 主要生产设备清单 (Major production machinery list);
; Z! o/ E/ c2 I+ { O+ i11.设备保养计划 (Machinery maintenance schedule);$ B4 C" x2 T9 E/ I
12. 设备保养记录 (Machinery maintenance records);
; n. g3 J. L) i6 C13. 仪器清单 (Test and measure equipment list);
* V1 A+ J4 p7 M6 W0 G7 U3 A7 m14. 仪器校准计划 (Test and measure equipment calibration schedule);
# v6 w4 j J# ^15. 仪器校准记录 (Test and measure equipment calibration records):
& S; V* Y8 N, y6 U! H6 L1 |1)外校报告 (External calibration reports);0 J& L. c; `- m* v
2)内校人员资格证书 (Internal calibration personnel qualification)
. y. J/ e7 n5 W3)内校规程 (Internal calibration instruction);
0 O! A, c5 b2 L4)内校报告 (Internal calibration reports
. d- U5 W2 k' t- [" U( X16. 年度培训计划 (Annual training plan) \2 j6 L5 s4 X* M, ~' v
17. 培训记录 (Training records): x9 A8 c/ ^7 v2 P& g3 g; {* O
1) 签到表 (Training attendee signature);
; A2 P, N5 A& t; V8 y1 W W0 m! @+ l2)测试卷 (Training effectiveness verification records
7 Q g+ `) Z) R' k V' |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);4 Q) F# r6 ^7 m
19. 新产品设计开发资料 (New products design and development records):
) J( P" q0 B: K a1)产品规格书 (Product specification);
7 Z+ g# `/ ?! e- l. f% }: l2) BOM表 (BOM);; T0 H; `& ~+ k. K
3)安规认证证书 (Safety certificate);" U, T# q r9 z* ~: g( x9 Y& V
4)样品检测报告 (Design samples test and inspection reports)
3 m( E8 k# ]$ o" `/ p0 Y5)试产记录 (Pilot runs record);
2 ]. K* z' q3 U3 R' S) S! E$ r) U$ k6) 试产评估报告 (Pilot runs review records);
9 M+ D% ~. @4 F: G* J- V. N7) 作业指导书 (Work instruction);
; r- w( I6 t/ Q; K7 A8)检验标准 (Inspection standard);
( Z- E- P5 p `, U$ }2 ]+ o9) FMEA分析资料 (FMEA analysis report);
$ s# V: N8 G* i4 [2 z10)产品质量控制计划(QC工程图)-Product quality control plan/chart." R, k, C4 i/ Q! B% i, t. X
20. 订单评审记录 (Order review records);
" R0 _1 R" M+ Y8 r21. 新供应商资格评定报告 (New suppliers evaluation reports) v, q1 m" p+ j
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);" Q/ ]1 |, b0 j0 v9 a& Z0 o
23. 原材料采购订单 (Materials purchasing order);- N# m7 m7 A1 L) v
24. 原材料规格承认书 (Materials specifications)( I: S5 E: [1 O- E
25. 进料检验作业指导书 (incoming inspection procedure/instructions);' n3 q6 {0 `: ^4 L' o2 H
26. 进料检验标准 (Incoming inspection standards);
* Q7 [5 x+ B) h( a27. 进料检验样板清单及定期评估记录 (Incoming inspection samples list and its periodic review records);
3 e/ K: ~* v5 Z r E1 T28. 进料检验记录 (Incoming inspection records);1 T! z6 Z- ^' e" n
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);* I3 d' @, P r# U* n9 Z. ^, v
30. 原材料保存周期规定 (Materials storage period instruction);
s% W6 ~$ k! n9 H31. 原材料过期重检记录 (Materials periodic re-inspection records);
! W2 c+ K4 ~8 `, g1 f8 J( _9 p32. 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);5 @# d% O; n$ b9 f
33. CPK应用指引 (CPK usage guideline);
; I; n8 k7 ^' S: x) y34. 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);% F, ^ N+ x, k; t; a
35. 生产作业指导书 (Work instruction);
! Q; D o4 r a2 y' x- t# j8 \36. 制程检验作业指导书 (In-process inspection procedure/instruction);
3 I7 b1 g( B2 h; E) [. c' E3 _, { T, M37. 制程检验标准 (In-process inspection standards);
5 v% `& f; j8 f" g* l0 m38. 制程检验记录 (In-process inspection records):9 x2 s( X; M7 {1 U/ j- c
1)首件检验记录 (First article inspection reports);7 P/ v I4 h. n3 ^" y
2)巡检记录 (Production line tour inspection records);8 d5 Q; @/ r1 [: \- I( q o- v- J
3)抽检记录 (Sampling inspection records)
6 C B7 ^1 }2 p/ V9 d39. 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);
0 s. C: G( U5 S* a4 b40. 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
6 S. i* u' n6 V5 T41. 停线管理规定及记录 (Production stop procedure and records);- v1 j: D. _0 m5 B2 Y$ [
42. 成品检验作业指导书 (Final inspection procedure/instruction);
" W# x) U$ c, w0 R43. 成品检验标准 (Final inspection standards);
7 U5 H9 D) @ o* W) p44. 成品检验记录 (Final inspection records);
% ^. H7 { C+ q: a) ~9 H45. 不合格成品处理记录 (Non-conforming products handling records):+ ?7 k; g1 v6 E5 a2 Q
1)返工、返修记录 (Rework, repair records);& H* J# K) k" i0 P& { I' U7 c
2)重检记录 (Re-inspection records)
. w6 v) H( Y9 c Q8 f+ Q/ m3) 纠正预防措施报告 (Corrective and preventive actions report
. s- v& O: B$ r) _46. 成品入库单 (Finished products warehouse-in records);& ]* C) _, g) V- L
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);
1 n- y9 Z/ e1 x& A! z& z2 \3 z48. 数据分析程序 (Data analysis procedure);3 R$ U( K, {" f" Y" n
49. 质量目标统计资料 (Data analysis records-mainly focus on quality objectives analysis records- J$ Y" j/ W# {. F
50. 客户沟通资料 (Customer communication records);
3 X4 e" j, B5 V- W51. 客户投诉处理程序 (Customer complaints procedure);( D' W: J! j2 a/ n
52. 客户投诉处理记录 (Customer complaints handling reports) |
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