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质量体系审核文件资料清单# v' P) Z; P7 ]4 X" w+ I
0 Q7 q# C% J" b2 X) @1 U/ {Documents List for QMS Audit0 x. M: H8 l3 {- z1 {& w! @
1. 营业执照 (Business Licenses);
9 z; i8 Y/ b4 g5 j: O4 `& B2. 质量体系认证证书 (QMS certificate);
* K- H2 f$ d4 |' J3 s8 c3 O l f3. 组织架构图 (Organization Chart);
, r: a! b% C* Q9 B! w1 f0 u4. 质量手册 (Quality manual);# Y0 o/ X" D4 @: B7 q1 F* k
5. 程序文件 (Quality procedure);
: ^7 ?- B. S0 c9 D6. 质量体系内审计划 (QMS internal audit plan);% |5 D; \* `1 y( \
7. 质量体系内审记录 (QMS internal audit records):
$ Y8 T; p6 ^8 G0 D9 H& y$ |9 @: ~1)内审员资格证书 (Internal auditor qualification certificate);
" a# u# v: I. R3 N: l4 R1 K2)首末次会议 (Opening meeting and close meeting records);
& l( D8 Z! C5 J K" z3)检查表 (QMS internal audit checklist);
! H& p) X, A8 _- m9 V4)不符合项报告 (QMS internal audit NC reports);
9 X0 z( A% U5 _! h" s6 v5)内审报告 (QMS internal audit report)! k( _+ A$ } B! ?8 d/ ^0 o9 _
8. 质量体系管理评审计划 (QMS management review plan)
# t1 {3 N7 ]6 A4 @2 J* E6 Y9. 质量体系管理评审记录 (QMS management review records):
1 F- Z$ ]1 D5 A+ R- n! N1)管理评审会议记录 (QMS management review meeting record);
7 x; G( ^% R4 a2)管理评审报告 (QMS management review report);
8 L( [$ B: r+ ]# y! O% o# Q, |3)决议事项的跟进记录 (QMS management review decisions follow-up records)5 P3 ?' G( \' u9 u
10. 主要生产设备清单 (Major production machinery list);
9 l/ R5 q4 { T2 ?7 W11.设备保养计划 (Machinery maintenance schedule);3 j0 X) d% S: z0 l4 c% a* w
12. 设备保养记录 (Machinery maintenance records);
( J& m$ K( p# M7 M8 R1 `8 `13. 仪器清单 (Test and measure equipment list);6 T. {1 z9 y' u/ b
14. 仪器校准计划 (Test and measure equipment calibration schedule);* {! S3 E3 E7 i7 d' s8 x
15. 仪器校准记录 (Test and measure equipment calibration records):
8 G& j$ \+ m. V. @; Q2 i8 [) f7 G1)外校报告 (External calibration reports);
6 Z8 @ N% ~; z T2)内校人员资格证书 (Internal calibration personnel qualification)% G* f, ^! A( a8 K) `- t1 I
3)内校规程 (Internal calibration instruction);, M: _7 E# O }% \% j
4)内校报告 (Internal calibration reports0 Q0 {# \, F _
16. 年度培训计划 (Annual training plan)4 y$ i% z' k( e6 L. C$ U' l
17. 培训记录 (Training records):
: Y9 x- z' Y/ L* ~/ R1) 签到表 (Training attendee signature);
& _6 D3 T9 f1 ?* w) T0 N2)测试卷 (Training effectiveness verification records
p3 \2 ]* X' e# b$ U: h' _# G& F18. 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);
5 H/ `) A6 s, P/ y% R; A19. 新产品设计开发资料 (New products design and development records):+ @( i2 b1 l: p2 h
1)产品规格书 (Product specification);% @, \; `; k4 x; r( R( l
2) BOM表 (BOM);. E/ u9 U" }9 N! i4 b
3)安规认证证书 (Safety certificate);' `) q. M; I7 r0 k' p
4)样品检测报告 (Design samples test and inspection reports)7 n5 Q* f; c+ `: X5 b4 U3 x$ @" A7 t
5)试产记录 (Pilot runs record);8 L( b/ Y4 W0 S0 c% \0 u0 r
6) 试产评估报告 (Pilot runs review records);
: |. R# [( l8 g0 T9 m% [4 U' j7) 作业指导书 (Work instruction);) Y! ~' X* l' [
8)检验标准 (Inspection standard);: K+ o+ b4 u7 ^$ } U( O) ~6 x
9) FMEA分析资料 (FMEA analysis report);
6 C# {3 L1 f \4 |9 X10)产品质量控制计划(QC工程图)-Product quality control plan/chart.
/ V5 H) k4 S8 J20. 订单评审记录 (Order review records);
! l* V# y. M4 A4 c21. 新供应商资格评定报告 (New suppliers evaluation reports)
# {" R" m- z' O# r22. 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);! n. n: g4 V# p' R$ {
23. 原材料采购订单 (Materials purchasing order);
4 C2 \6 N" P* [* z& F24. 原材料规格承认书 (Materials specifications); Y- e6 s! z+ ?* s/ M6 N' I
25. 进料检验作业指导书 (incoming inspection procedure/instructions);
" w1 K+ e6 ~( W" y- Q3 d26. 进料检验标准 (Incoming inspection standards);
& G. m& U; x9 {* {' w+ R% j27. 进料检验样板清单及定期评估记录 (Incoming inspection samples list and its periodic review records);; ?* B2 B8 @& r S2 Y9 B( {
28. 进料检验记录 (Incoming inspection records);
- B- [$ W# V [) R& [8 f0 Q; p" D29. 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);
+ ~1 E: D6 J c30. 原材料保存周期规定 (Materials storage period instruction);
& {1 }8 @' p+ L0 K31. 原材料过期重检记录 (Materials periodic re-inspection records);6 p4 k; I& K& n8 e) z( `
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);
1 G* G5 W0 J% E1 O' e4 M33. CPK应用指引 (CPK usage guideline);
! p6 e9 @' ?. C4 e34. 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);
5 b) l( k4 ?7 @8 O5 o9 {9 u35. 生产作业指导书 (Work instruction);8 E- \& R% ~& M2 \0 V: C7 b' [" E6 O
36. 制程检验作业指导书 (In-process inspection procedure/instruction);
2 O8 J; E6 {/ s, h$ b, f7 G37. 制程检验标准 (In-process inspection standards);
! ^6 w# p& w( E/ B0 b* s38. 制程检验记录 (In-process inspection records):, A1 b. r& A$ p r
1)首件检验记录 (First article inspection reports);
1 ], Q; s9 M6 G3 Q/ X6 U C" F7 C* s1 h2)巡检记录 (Production line tour inspection records); a' A& o$ a, ~7 w+ S* U; J# `
3)抽检记录 (Sampling inspection records)+ \: F" H$ ]' R) _# }( d1 [' { A' e
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);0 ^' \* ~8 v! h1 Y! ^6 o5 V
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
. L9 l, ]5 {% U- Q8 `+ K) ]41. 停线管理规定及记录 (Production stop procedure and records);0 c/ h" C& {5 \6 g1 ?
42. 成品检验作业指导书 (Final inspection procedure/instruction);
- \! c% q; |( J, n* u43. 成品检验标准 (Final inspection standards);4 m9 E$ `2 K$ Q* y# Y
44. 成品检验记录 (Final inspection records);
+ @! h7 {# R: o0 A1 F45. 不合格成品处理记录 (Non-conforming products handling records):. T! F# M6 ]) S& S. ~6 _, A4 R
1)返工、返修记录 (Rework, repair records);
0 ?' q2 Q S4 _+ R |$ y2)重检记录 (Re-inspection records)
3 N6 A8 m; {# z t# B3) 纠正预防措施报告 (Corrective and preventive actions report
( `( V; r0 _6 X' C46. 成品入库单 (Finished products warehouse-in records);6 l9 w1 B. q; }3 T) W& F3 o1 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);
0 D" J2 }2 m3 o4 _8 `7 f48. 数据分析程序 (Data analysis procedure);
9 S) H; |0 o2 W/ k [% v9 b49. 质量目标统计资料 (Data analysis records-mainly focus on quality objectives analysis records
1 m7 V1 A/ S. m7 n/ ~0 m50. 客户沟通资料 (Customer communication records);" n8 @# A0 |( \ i/ V9 j
51. 客户投诉处理程序 (Customer complaints procedure);
/ i* A8 i# V" U3 N# J! s52. 客户投诉处理记录 (Customer complaints handling reports) |
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