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质量体系审核文件资料清单
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, B9 l; a' C4 G: |Documents List for QMS Audit: L! j2 c+ |+ Q1 o: L& X/ L
1. 营业执照 (Business Licenses);
: Y6 j5 z, H4 G, I2 ?- J3 L7 Q2. 质量体系认证证书 (QMS certificate);: |( e+ S% w2 [: B* y+ g
3. 组织架构图 (Organization Chart);
; S; D$ m2 b: i2 \, V! K4. 质量手册 (Quality manual);
+ ?' j+ w( G* A/ J+ z/ _5. 程序文件 (Quality procedure);
( C7 j2 `1 B: O# R1 U1 a6. 质量体系内审计划 (QMS internal audit plan);, C# o. t7 Q% ~7 _
7. 质量体系内审记录 (QMS internal audit records):! o1 K+ v" H9 ~. w
1)内审员资格证书 (Internal auditor qualification certificate);
- H) X. J) X6 W* ?+ _& M! v2)首末次会议 (Opening meeting and close meeting records);4 @& K( f, R/ F4 M' r! ?
3)检查表 (QMS internal audit checklist);7 Q' p' [2 @$ L, Z- F: Y. H$ p
4)不符合项报告 (QMS internal audit NC reports);! s/ C x+ A( I; u/ A9 z/ d- |
5)内审报告 (QMS internal audit report)
% Z/ V4 a7 O! g8. 质量体系管理评审计划 (QMS management review plan)! d0 o( f- A! B' J
9. 质量体系管理评审记录 (QMS management review records):* c, }! j2 \2 d3 m* W p
1)管理评审会议记录 (QMS management review meeting record);+ ]! @! }" _1 H% R
2)管理评审报告 (QMS management review report);- w4 {$ k" p- @" F" c- S& j
3)决议事项的跟进记录 (QMS management review decisions follow-up records)4 t/ ?! ^4 l7 S
10. 主要生产设备清单 (Major production machinery list);
0 C5 S% z3 T4 W3 d$ ~11.设备保养计划 (Machinery maintenance schedule);; a3 U9 E) J- ?
12. 设备保养记录 (Machinery maintenance records);" H9 T, G6 ]) n0 c% M# I' i
13. 仪器清单 (Test and measure equipment list);$ h: D/ @! Q0 n2 ?% g6 _- t8 Z
14. 仪器校准计划 (Test and measure equipment calibration schedule);
( `) W8 T' B, d$ f) U9 T6 c& w8 m7 j15. 仪器校准记录 (Test and measure equipment calibration records):
: {7 N( p( R2 ^& o( X. c" w) a1)外校报告 (External calibration reports);
" r7 M% O0 k' r' Q2)内校人员资格证书 (Internal calibration personnel qualification)
9 W( `/ u; [( r3 a! I0 C3)内校规程 (Internal calibration instruction);9 ?6 C7 Y" T! V( A4 i9 u
4)内校报告 (Internal calibration reports
& @0 { D7 }, O1 s- M' ]16. 年度培训计划 (Annual training plan)" s' H# z6 }( ~0 b, l) W) {( ~0 m3 O
17. 培训记录 (Training records):
" a$ ^6 U) V# K1 V8 n w; T7 C( z1) 签到表 (Training attendee signature);) R2 J! ^6 O; p6 V- U
2)测试卷 (Training effectiveness verification records0 t! i* ]5 J& g0 e, x/ h9 t9 T
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 [+ o. C/ x2 j3 Q' K' D, _; _
19. 新产品设计开发资料 (New products design and development records):
9 x; E+ R1 z& n. K2 H2 W1)产品规格书 (Product specification);
+ p6 p, \/ b7 u N3 F7 T# p: S2) BOM表 (BOM);& m3 g% C% E% m# C2 [" C8 g
3)安规认证证书 (Safety certificate);
, e! | n$ I/ G3 D1 { A4)样品检测报告 (Design samples test and inspection reports)
& z* C8 ]6 q& ?" J( {* S0 z& G5 {, l5)试产记录 (Pilot runs record);
/ p V) O8 J( A- H; U3 O8 F9 s6) 试产评估报告 (Pilot runs review records);
4 @+ ^8 O0 E6 c( O) A6 Q- _7) 作业指导书 (Work instruction);
8 [$ p' ^$ n6 r2 G4 z7 L0 U3 e8)检验标准 (Inspection standard);
/ R5 {: u4 T: O9) FMEA分析资料 (FMEA analysis report);
, `: }+ @$ K# P! [- R7 m10)产品质量控制计划(QC工程图)-Product quality control plan/chart.: `# a/ F5 L v) B1 I5 c
20. 订单评审记录 (Order review records);
; n7 M9 t7 \8 L; t21. 新供应商资格评定报告 (New suppliers evaluation reports)
# W4 q4 q$ g* J3 }; J+ r% 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);& u/ {& l. b0 H% ?( H, i1 @+ I0 _
23. 原材料采购订单 (Materials purchasing order);
+ T1 T9 k6 l* V24. 原材料规格承认书 (Materials specifications)
& _4 i+ l% y) v% D9 g& g) X25. 进料检验作业指导书 (incoming inspection procedure/instructions);
9 b4 O1 P$ ], z& _26. 进料检验标准 (Incoming inspection standards);
A C+ G* R/ e/ ]/ r' K- d9 H7 K27. 进料检验样板清单及定期评估记录 (Incoming inspection samples list and its periodic review records);) `* T* T( U/ `
28. 进料检验记录 (Incoming inspection records);# j3 H! g7 W- z* t1 m% K! A
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);
0 ]. J' {' R/ `; M$ F30. 原材料保存周期规定 (Materials storage period instruction);
! R0 @% L# s; ]$ I31. 原材料过期重检记录 (Materials periodic re-inspection records);
# j2 n6 @0 W2 w# G, M32. 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% z, V9 f# J, k, F8 `3 j
33. CPK应用指引 (CPK usage guideline);
! F8 P0 b/ C! Z) a: y B34. 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);
$ c$ l/ _$ M, n$ V9 }& [35. 生产作业指导书 (Work instruction);
, z% ]2 e. P1 C; e+ |1 v% V0 T! r36. 制程检验作业指导书 (In-process inspection procedure/instruction);$ R" Y5 D- A0 k! ?8 C
37. 制程检验标准 (In-process inspection standards);
2 n" Q, K( \, C2 d e; x38. 制程检验记录 (In-process inspection records): T5 L; c2 S( O9 _/ d5 N! p
1)首件检验记录 (First article inspection reports);
" G, l6 a+ Y0 I% Z% g+ B2)巡检记录 (Production line tour inspection records);7 S5 c3 b. P% y, L5 A+ F% {& S0 y- Y
3)抽检记录 (Sampling inspection records)6 g* X! t5 Q# W0 P0 X& b5 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);
* L9 _0 X' L! _8 E40. 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 g7 r; A2 J6 o
41. 停线管理规定及记录 (Production stop procedure and records);
: e5 s/ A2 q9 }' j( L42. 成品检验作业指导书 (Final inspection procedure/instruction);
. c" W% }( g+ _& Y' E# `43. 成品检验标准 (Final inspection standards);
) v3 ^2 m3 E, N V6 o$ {) O' T @44. 成品检验记录 (Final inspection records);
* F3 s& T8 n' Y45. 不合格成品处理记录 (Non-conforming products handling records):% A' _" ]( T1 D& m2 W
1)返工、返修记录 (Rework, repair records);
, Z; _6 [1 D# D$ O( _2)重检记录 (Re-inspection records)% C" T; u7 E2 G3 ~9 I+ u9 {$ ?. k
3) 纠正预防措施报告 (Corrective and preventive actions report2 g: y; s9 q. Z X
46. 成品入库单 (Finished products warehouse-in records);
) ^9 I" H5 A; W: Q# V8 j; w* _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);
# c+ n+ p6 K( P7 c* R& ^ s' G48. 数据分析程序 (Data analysis procedure);3 m9 p5 v4 E5 s
49. 质量目标统计资料 (Data analysis records-mainly focus on quality objectives analysis records- v3 J3 m) i6 `" t3 ^6 Y$ [
50. 客户沟通资料 (Customer communication records);
: Q1 o& L7 z2 s51. 客户投诉处理程序 (Customer complaints procedure);
: n/ c ?) v* H3 X0 @2 F! w8 {52. 客户投诉处理记录 (Customer complaints handling reports) |
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