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质量体系审核文件资料清单
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3 B. V# J6 h. a3 e9 X* ]Documents List for QMS Audit0 p7 O- U0 z5 J1 V0 _/ ~5 y9 b
1. 营业执照 (Business Licenses);
) K* j8 Q; q C2. 质量体系认证证书 (QMS certificate);
. n3 [ e& u, c. U2 l' M5 W3. 组织架构图 (Organization Chart);. m0 W" T" C) \1 |
4. 质量手册 (Quality manual);
1 ?+ W: _' b! y5 J6 r5. 程序文件 (Quality procedure);
, m+ i* v( U- U" \6. 质量体系内审计划 (QMS internal audit plan);
2 p/ P. R5 ?1 n$ G6 S$ h$ G0 n* B7. 质量体系内审记录 (QMS internal audit records):/ |; r4 o# k: _$ n2 S
1)内审员资格证书 (Internal auditor qualification certificate);
4 h2 T7 {" {0 t4 @2)首末次会议 (Opening meeting and close meeting records);9 D$ t! q& I0 S; [8 c7 T3 b
3)检查表 (QMS internal audit checklist);' `0 R$ n$ N. T, P- p3 u
4)不符合项报告 (QMS internal audit NC reports);
* j' [! G8 K* V, R" x9 u7 K5)内审报告 (QMS internal audit report)
; E* @1 m/ E8 m, H8. 质量体系管理评审计划 (QMS management review plan)
' y/ \, E% b, @/ J" Q7 u5 F9. 质量体系管理评审记录 (QMS management review records):! g: T$ f) Y' B' ^& J5 Z" U0 X
1)管理评审会议记录 (QMS management review meeting record);
5 n2 Y7 P; v( {$ M4 S/ i2)管理评审报告 (QMS management review report);9 K- I5 N1 j# ]* R
3)决议事项的跟进记录 (QMS management review decisions follow-up records)
; K' j4 U0 k! R10. 主要生产设备清单 (Major production machinery list);
9 Z& Q5 `" p4 E" N3 n# [3 r" I6 t11.设备保养计划 (Machinery maintenance schedule);
* ?% Y0 e& U% x& o. p12. 设备保养记录 (Machinery maintenance records);4 \/ k$ k0 u; N6 P/ g, I* F
13. 仪器清单 (Test and measure equipment list);
1 S3 d8 B2 H' h+ Y1 L* M$ a. Q14. 仪器校准计划 (Test and measure equipment calibration schedule); w- T, R. K# e5 D' E& G7 R
15. 仪器校准记录 (Test and measure equipment calibration records):: ?: M# I2 V8 o. H8 \+ S
1)外校报告 (External calibration reports);
, H7 L9 d5 I$ F, R* c2)内校人员资格证书 (Internal calibration personnel qualification)
/ F# {7 g+ B! L1 V+ [' l' a7 T3)内校规程 (Internal calibration instruction);
4 w+ p! W) o! `; _4)内校报告 (Internal calibration reports7 p" }2 E- G+ V% d
16. 年度培训计划 (Annual training plan)$ A3 U% C" ~# k% N# ?& V/ G
17. 培训记录 (Training records):* a) `: r7 T o, w8 w9 @9 Q
1) 签到表 (Training attendee signature);, u( E1 |5 A" E2 }, l4 ]; r
2)测试卷 (Training effectiveness verification records3 N2 S% L# {/ b X/ S9 }4 w
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);. m9 V. @+ p& s+ w
19. 新产品设计开发资料 (New products design and development records):
d z! g# M0 P0 w( h1)产品规格书 (Product specification);5 Z! ~" c" O/ Z O9 u6 g7 N, [- |
2) BOM表 (BOM);6 S @8 k: W _* J) {5 v& a4 q
3)安规认证证书 (Safety certificate);8 E! l9 B4 n8 e5 _9 m, c- z2 s0 s
4)样品检测报告 (Design samples test and inspection reports)" L& n3 m1 k1 D- B7 Y$ e9 d; q! t! N
5)试产记录 (Pilot runs record);
. V: V- u) Q# Y# p i( m( Y/ H$ n! m6) 试产评估报告 (Pilot runs review records);# _8 W4 c0 y% J, B5 G* B
7) 作业指导书 (Work instruction);
" A/ E8 ]* ^# Z5 q! E p+ |8)检验标准 (Inspection standard); f8 t% W7 e7 T# r, i. H- _
9) FMEA分析资料 (FMEA analysis report);) i/ u, L; Z* {7 j, k
10)产品质量控制计划(QC工程图)-Product quality control plan/chart.0 T' k1 _! [6 \; R. Z+ o
20. 订单评审记录 (Order review records);
+ c8 _& m4 S* U" \3 g21. 新供应商资格评定报告 (New suppliers evaluation reports)
) g% n1 [' J4 F* d6 ]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);
0 X0 L+ {+ n2 o' _. Y& {23. 原材料采购订单 (Materials purchasing order);
- K2 Q5 P/ I0 |4 i24. 原材料规格承认书 (Materials specifications)3 u2 c) P( v/ ] u& e5 C
25. 进料检验作业指导书 (incoming inspection procedure/instructions);" ?; h% u$ Q* g" ~9 K: Y) q4 X
26. 进料检验标准 (Incoming inspection standards);) a6 N. q* e6 g+ G- Z. T: {
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);
8 Q6 q3 [; G$ {8 x0 e9 q28. 进料检验记录 (Incoming inspection records);
7 M4 U, C) d6 e- \8 R29. 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 V, s a, ?2 p* F30. 原材料保存周期规定 (Materials storage period instruction);* k7 O: M6 K9 O" N8 M8 J
31. 原材料过期重检记录 (Materials periodic re-inspection records);
" X0 u, x1 q5 k A! X# a6 r( w32. 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) X8 ~4 Y# x6 G
33. CPK应用指引 (CPK usage guideline);
7 W* G# G0 D, N3 J34. 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);1 P! Y3 t( H j1 J
35. 生产作业指导书 (Work instruction);; j4 U8 F `. ^# M& v
36. 制程检验作业指导书 (In-process inspection procedure/instruction);
* w% `3 O3 c! B$ s# `$ ~37. 制程检验标准 (In-process inspection standards);
( m. f" N; r: v& T: c1 l38. 制程检验记录 (In-process inspection records):' {7 J( g1 I0 x \
1)首件检验记录 (First article inspection reports);* D$ k! g- U* ]0 L$ r, @ s
2)巡检记录 (Production line tour inspection records);
7 `: Y2 j! x! @" s3)抽检记录 (Sampling inspection records)3 o2 K0 L( D, k& F4 @+ @5 t1 U
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);3 a! d( k- c5 D" U& w
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* q4 u- l3 T) M6 \
41. 停线管理规定及记录 (Production stop procedure and records); u1 H: P) c% S* w3 ]& s# T3 Z
42. 成品检验作业指导书 (Final inspection procedure/instruction);
& ^" d- {4 r8 E1 [: W; Q* h8 V43. 成品检验标准 (Final inspection standards);) E3 r0 r) a9 @/ O; i
44. 成品检验记录 (Final inspection records);7 z1 ^' _* G2 B( p# ^" p
45. 不合格成品处理记录 (Non-conforming products handling records):) w. ^4 c* @8 D
1)返工、返修记录 (Rework, repair records);
* \: [7 o: F- S/ e4 o2)重检记录 (Re-inspection records)
3 S+ V" c: m% {& j5 p3) 纠正预防措施报告 (Corrective and preventive actions report' a0 s6 s5 {2 F
46. 成品入库单 (Finished products warehouse-in records);
* g" G- P1 L, g9 |! {' Z5 }$ ^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);8 a" m2 K5 [" C
48. 数据分析程序 (Data analysis procedure);, c2 k' M+ y; d: r1 |$ w1 ~: h
49. 质量目标统计资料 (Data analysis records-mainly focus on quality objectives analysis records
3 o4 ~+ ]+ O2 H. v50. 客户沟通资料 (Customer communication records);
" ^2 t. `% O. S% s- [7 z# z; C51. 客户投诉处理程序 (Customer complaints procedure);. G5 j4 e" R v$ D" ^. L* o
52. 客户投诉处理记录 (Customer complaints handling reports) |
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