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质量体系审核文件资料清单5 Q3 W V) s9 ?9 L9 g. B. m5 l
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Documents List for QMS Audit9 r1 r: \- G4 y8 h! A* [
1. 营业执照 (Business Licenses);9 e5 t3 w8 ]' n
2. 质量体系认证证书 (QMS certificate);& }3 c- m7 G8 E/ Y8 X
3. 组织架构图 (Organization Chart);
# ?% V' C( Q9 a3 f) I3 L* ]8 I4. 质量手册 (Quality manual);- q& t, x! X9 C! p
5. 程序文件 (Quality procedure);5 I7 U% ?' I, U g% s9 s9 ?! I: c q
6. 质量体系内审计划 (QMS internal audit plan);
, [3 s4 _( O# v5 {7. 质量体系内审记录 (QMS internal audit records):
, v; I% E8 b2 |: ]: v# L N1)内审员资格证书 (Internal auditor qualification certificate);; ~7 k( W' C$ ]) i
2)首末次会议 (Opening meeting and close meeting records);
8 `6 M0 h0 M, T9 w3)检查表 (QMS internal audit checklist);
, V" k1 C8 {, X& L4)不符合项报告 (QMS internal audit NC reports);8 l2 Z0 f m5 }& l0 }
5)内审报告 (QMS internal audit report)
. W. t" _' P" X% ~2 k8. 质量体系管理评审计划 (QMS management review plan)
3 `3 G2 p- f) h, U! X6 E( w9. 质量体系管理评审记录 (QMS management review records):
+ R4 c- v1 x4 W; z* c y1)管理评审会议记录 (QMS management review meeting record);
: B) g6 H& k' m- e0 D/ G: U8 ~/ `2)管理评审报告 (QMS management review report);
. ` [3 \5 j R. w8 n- F) P. }3)决议事项的跟进记录 (QMS management review decisions follow-up records)
' G& f" H; Y! I9 m8 o2 k0 J10. 主要生产设备清单 (Major production machinery list);
1 ~, x1 O( x w+ j11.设备保养计划 (Machinery maintenance schedule);
7 q7 q( q& w6 u. H12. 设备保养记录 (Machinery maintenance records);
+ A) B/ [ z. p7 P: S0 w" p! K13. 仪器清单 (Test and measure equipment list);
: V0 t$ F) T) [) m! m0 R/ s; Z14. 仪器校准计划 (Test and measure equipment calibration schedule);, O7 ~" g/ a' M& W0 J5 k
15. 仪器校准记录 (Test and measure equipment calibration records):) [" o3 o# n* Q; F; e8 E/ j* |6 Y% K
1)外校报告 (External calibration reports);
2 }6 J5 Z; i. V- N) ?! \2)内校人员资格证书 (Internal calibration personnel qualification)6 q# g* c# q- Z$ v! l0 ]& t
3)内校规程 (Internal calibration instruction);2 f- C! _! c H& c. I
4)内校报告 (Internal calibration reports# x ^( s8 f! k5 h$ ]2 l1 [- F; Z
16. 年度培训计划 (Annual training plan)
, c. C9 k' B: N2 Z17. 培训记录 (Training records):5 M' ?# [$ T$ ?+ u9 W1 [# ?# e I
1) 签到表 (Training attendee signature);
9 b' y! j2 g. ~1 d2)测试卷 (Training effectiveness verification records
8 E9 E3 j6 ]+ a; D18. 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);% e2 D, |0 x0 e1 a+ e0 Z# P
19. 新产品设计开发资料 (New products design and development records):
: |6 x8 h/ H/ \4 C3 G1)产品规格书 (Product specification);
4 _8 T0 u) ~! j1 P2) BOM表 (BOM);
1 w9 E/ c% t2 u. A" q9 W% ~ @3)安规认证证书 (Safety certificate);
) s0 f2 C b' l4)样品检测报告 (Design samples test and inspection reports)" f: b y" L% \& c& k
5)试产记录 (Pilot runs record);
! T f1 d) c+ {1 R9 u' p3 J! \6) 试产评估报告 (Pilot runs review records);" i3 N$ C( W X1 c% L( B
7) 作业指导书 (Work instruction);
( r E" O8 x- _1 w: @; [8)检验标准 (Inspection standard);* e8 I! E# O6 l$ L
9) FMEA分析资料 (FMEA analysis report);% W5 _4 ^" S: W4 ^ ~4 {
10)产品质量控制计划(QC工程图)-Product quality control plan/chart.
+ a5 D6 F+ o$ o' ?, ?9 f20. 订单评审记录 (Order review records);+ j2 L' y7 L# z! h* t. g+ u
21. 新供应商资格评定报告 (New suppliers evaluation reports)& g) \. e1 \! v/ a5 Y# U$ T3 `
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);
) p1 y, V1 |9 b, s' i23. 原材料采购订单 (Materials purchasing order);
" T5 g+ J/ V7 i$ W4 y& `& t" G24. 原材料规格承认书 (Materials specifications)
; c& } J3 e- U3 R( g& N" F25. 进料检验作业指导书 (incoming inspection procedure/instructions);
" t& ]) K- G \26. 进料检验标准 (Incoming inspection standards);
- `: z. g$ @9 o7 C. M# @ M27. 进料检验样板清单及定期评估记录 (Incoming inspection samples list and its periodic review records);
1 B! K% O) n! q" P28. 进料检验记录 (Incoming inspection records);
0 X. u1 M0 k' G3 L( I4 v29. 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);! f& t' l0 [( D
30. 原材料保存周期规定 (Materials storage period instruction);! g p" R! M4 E" d. l! i
31. 原材料过期重检记录 (Materials periodic re-inspection records);
8 b0 h# D% l2 r4 U32. 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 m5 b; {0 F" [' q/ I! K33. CPK应用指引 (CPK usage guideline);
! t7 P4 n4 U) O/ t- B2 x34. 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 W B7 V: o/ H& H) f
35. 生产作业指导书 (Work instruction);) _9 i7 c' H7 ^( i
36. 制程检验作业指导书 (In-process inspection procedure/instruction);
0 A/ P* Z b; c8 l7 [37. 制程检验标准 (In-process inspection standards);
* z* e" h9 Y/ w B38. 制程检验记录 (In-process inspection records):
6 S( ?7 R/ m& t3 d; n( ~1)首件检验记录 (First article inspection reports);3 ?( O2 @' k+ L" @) w
2)巡检记录 (Production line tour inspection records);& k( o+ y- O) v
3)抽检记录 (Sampling inspection records)
: e7 s: V+ a$ ^" }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);
; o4 |9 S; W' ~" G40. 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- g, ~" c/ L- p8 A9 Q
41. 停线管理规定及记录 (Production stop procedure and records);
; e5 q* T7 S1 F- n5 }: e$ j42. 成品检验作业指导书 (Final inspection procedure/instruction);
( V. T, h7 M/ y) E( P9 l) u43. 成品检验标准 (Final inspection standards);
7 I7 x& N9 O: q44. 成品检验记录 (Final inspection records);
" k- F. x/ Y5 m* F. b$ g45. 不合格成品处理记录 (Non-conforming products handling records):
3 a3 L, \3 q% i1 y, u# C/ g+ h1)返工、返修记录 (Rework, repair records);
2 S- u. R+ d c/ v. x- ?# m3 ^2)重检记录 (Re-inspection records)# {. X1 V' }1 \# Y1 n: H' V
3) 纠正预防措施报告 (Corrective and preventive actions report
" T7 \; _: `, ]1 N6 _6 w* { b46. 成品入库单 (Finished products warehouse-in records);
: ?/ E$ B+ |6 s# \1 d t47. 产品可靠性及环境测试计划及记录 (Products reliability and environmental test plan/schedule and records);3 u$ f ?. ]" G. U/ f2 f
48. 数据分析程序 (Data analysis procedure);* o; |% B/ v: w$ `) P* B5 d$ o
49. 质量目标统计资料 (Data analysis records-mainly focus on quality objectives analysis records4 {1 g5 k, f: `- Q9 t( `2 X& W6 h
50. 客户沟通资料 (Customer communication records);0 ]- e3 ]# G2 W0 S5 o8 g) j
51. 客户投诉处理程序 (Customer complaints procedure);6 R1 ^8 q; A7 A% i
52. 客户投诉处理记录 (Customer complaints handling reports) |
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