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质量体系审核文件资料清单
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/ Y n9 c, l3 QDocuments List for QMS Audit6 I4 {' E( \1 [$ G4 h2 `) N5 }( r
1. 营业执照 (Business Licenses);3 w& i" P% I! ]
2. 质量体系认证证书 (QMS certificate);; N4 J: l4 e. Q; K1 F
3. 组织架构图 (Organization Chart);3 k# }5 q6 |8 F" C( d! {
4. 质量手册 (Quality manual);
6 K3 B Q, m8 }( y# b8 l, `4 M5. 程序文件 (Quality procedure);* q! B6 z( w% x* \1 T
6. 质量体系内审计划 (QMS internal audit plan);# g" j8 g2 D5 J* i! ^% r# g" p
7. 质量体系内审记录 (QMS internal audit records):5 K! q' } @+ m/ d/ T" G
1)内审员资格证书 (Internal auditor qualification certificate);% ?7 _- X- y5 T' B
2)首末次会议 (Opening meeting and close meeting records);
, n! U. k' Q, O: i8 E3 Y3)检查表 (QMS internal audit checklist);
2 s8 R3 f* H7 |& L4)不符合项报告 (QMS internal audit NC reports);! Q" Z! l0 f- \. {3 ]0 C
5)内审报告 (QMS internal audit report)$ o" \7 W) X3 O5 J4 _+ U' f
8. 质量体系管理评审计划 (QMS management review plan) ~ o: n/ T5 _7 Q0 z
9. 质量体系管理评审记录 (QMS management review records):
Z: C' p/ X+ G9 T/ _, {1)管理评审会议记录 (QMS management review meeting record);
% H& j5 _3 J0 Y. h% E1 c2)管理评审报告 (QMS management review report);
2 g; N6 M: g0 z+ F' P# R3)决议事项的跟进记录 (QMS management review decisions follow-up records)6 ^ s+ C# z3 h
10. 主要生产设备清单 (Major production machinery list);# s) c2 m4 {. Z* G0 k
11.设备保养计划 (Machinery maintenance schedule);
! k- @/ e# l. f3 I- [8 p; v% y12. 设备保养记录 (Machinery maintenance records);% G# `. m5 t4 V; `+ E# F
13. 仪器清单 (Test and measure equipment list);
% |0 T, K) J: ^6 R# b2 W) g8 n5 W14. 仪器校准计划 (Test and measure equipment calibration schedule);
" G1 j- b4 v8 g4 Q. G) g+ ?15. 仪器校准记录 (Test and measure equipment calibration records):
$ c7 i# u& \5 z/ o8 ]( L6 N5 y" e1)外校报告 (External calibration reports);
; b# z' P+ B2 V0 @2)内校人员资格证书 (Internal calibration personnel qualification)
- m: E- O8 D4 w" n4 F" z" I+ E3)内校规程 (Internal calibration instruction); i( [. b/ g3 y) K9 [
4)内校报告 (Internal calibration reports5 h" ?$ P% ~! p! w* G$ x8 [
16. 年度培训计划 (Annual training plan)
: j2 Y5 D9 P# w2 |17. 培训记录 (Training records):# m1 ]3 r+ E* o0 u; M( O7 ^2 b5 U
1) 签到表 (Training attendee signature);
, {/ C, ~ P* ~2 V) z8 P8 t: ~" C- F2)测试卷 (Training effectiveness verification records
M E* R g8 w5 o" Q8 I7 j9 O18. 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);$ ?1 c8 _" R6 J( @ w
19. 新产品设计开发资料 (New products design and development records):. S* F; f7 [/ i! {( I0 A
1)产品规格书 (Product specification);/ J. x; y: T, N- O- w
2) BOM表 (BOM);5 ~" D* p1 b; z% \; W4 ]
3)安规认证证书 (Safety certificate);, `# m/ \9 O2 V# ]; K
4)样品检测报告 (Design samples test and inspection reports)
4 p. Z% y* k3 N* C& [5)试产记录 (Pilot runs record);
' [1 n. @, e( e# {5 V! N) U6) 试产评估报告 (Pilot runs review records);* M8 d$ ~1 e: [1 Q8 M
7) 作业指导书 (Work instruction);0 p* b$ H( x8 b; A& p2 b
8)检验标准 (Inspection standard);+ D. h& J( e6 B2 H. y1 q' G) O
9) FMEA分析资料 (FMEA analysis report);9 t" _7 T1 a! q0 i6 H: ^5 c& C4 E
10)产品质量控制计划(QC工程图)-Product quality control plan/chart.% P& Z& h5 p0 Z, ?" h7 a, g- }8 C
20. 订单评审记录 (Order review records);
$ Z! W. J6 z2 M' ? N' b! E21. 新供应商资格评定报告 (New suppliers evaluation reports)
: @% x" Y9 L( o' W9 |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 A0 O" c; e/ j2 O% K: d23. 原材料采购订单 (Materials purchasing order);
7 f4 C# }# b. Q* `24. 原材料规格承认书 (Materials specifications)# f/ a$ H, v# F) c9 L% A. ^
25. 进料检验作业指导书 (incoming inspection procedure/instructions);
3 R) c; M/ }+ C d- U' w7 D, J: t26. 进料检验标准 (Incoming inspection standards);& ?/ \; X& `" f3 x& b* k6 g# ], X
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);& V. f6 e6 j' B2 \" [" m
28. 进料检验记录 (Incoming inspection records);) A* |3 ~6 y" g$ }8 [
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);7 R: ?: B1 O" q D! f3 Z
30. 原材料保存周期规定 (Materials storage period instruction);0 `' L. `2 O7 Z+ e* {: U
31. 原材料过期重检记录 (Materials periodic re-inspection records);
- x3 v3 U/ x& g% t& q+ l* @8 {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);% f! z/ Y- ?# N" |) Z. i0 a: c
33. CPK应用指引 (CPK usage guideline);
6 v$ U: l4 V% U& Y/ V; K: l34. 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);
- O& X, t( O' @) Y( c/ D' A35. 生产作业指导书 (Work instruction);
2 Y4 B8 N6 t) p. c3 b' D36. 制程检验作业指导书 (In-process inspection procedure/instruction);8 h" d6 d2 c& ]* B/ T; S
37. 制程检验标准 (In-process inspection standards);* C A; q$ P: k
38. 制程检验记录 (In-process inspection records):
4 J4 H' G1 o9 A8 A( d N' c1)首件检验记录 (First article inspection reports);. i5 ~* K5 k- ^$ ^' M
2)巡检记录 (Production line tour inspection records);
6 a1 T* |8 a+ a3)抽检记录 (Sampling inspection records)5 i) ~5 H: W! k- g: X& Q3 b+ g
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);+ j0 x. _7 u: {1 C, _6 [! w' x
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 figure5 s8 Q' H' {8 U# k0 X! r# H; C+ g
41. 停线管理规定及记录 (Production stop procedure and records);) |. z$ n U" }2 i3 n
42. 成品检验作业指导书 (Final inspection procedure/instruction);, w! g# {+ t$ h4 l4 Z3 o# n, ?" @8 x
43. 成品检验标准 (Final inspection standards);+ y ]% y# s8 d2 j* N3 n
44. 成品检验记录 (Final inspection records);; N6 R( ]; g4 M$ H; |
45. 不合格成品处理记录 (Non-conforming products handling records):" t, u, A& a/ \ P/ F4 s4 O+ t
1)返工、返修记录 (Rework, repair records);
3 X1 O" V3 @8 d' s2)重检记录 (Re-inspection records)' W2 P; ^% Z* U( s3 }9 s3 s
3) 纠正预防措施报告 (Corrective and preventive actions report7 @2 l) N, ]# m3 D8 Y# q( r
46. 成品入库单 (Finished products warehouse-in records);
9 H& n. k2 A! J( i+ s5 D) 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);
: q3 [) J2 r1 [- [6 m# W48. 数据分析程序 (Data analysis procedure);
9 ~' ?# K! e0 |% }2 l% r# j49. 质量目标统计资料 (Data analysis records-mainly focus on quality objectives analysis records
8 ^; C# W& @6 n8 C4 S/ b: |50. 客户沟通资料 (Customer communication records);6 v8 T. }" M8 r, f
51. 客户投诉处理程序 (Customer complaints procedure);
) I+ s1 C' \& T52. 客户投诉处理记录 (Customer complaints handling reports) |
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