|
|
No.
序號
|
DOCUMENT
|
文件
|
01
|
Business License | 營業(yè)執(zhí)照 |
02
|
Organization Chart | 組織結構圖 |
03
|
Key Staff Job Descrtption & Duty Vicegerent | 關鍵崗位的崗位職責/職務代理人 |
04
|
Production Flow Chart | 生產(chǎn)流程圖 |
05
|
Equipment List | 設備清單 |
06
|
Machines Maintenance Plan & Records | 設備保養(yǎng)計劃/記錄 |
07
|
Machines Repair Records | 設備維修記錄 |
08
|
Equipment Operation Instructions | 設備操作指引 |
09
|
Building/Equipment/ Products Cleaning Products and Records | 廠房(內(nèi),外部)/設備/產(chǎn)品的清潔程序/記錄 |
10
|
Training Records for Cleaning Staff | 清潔人員的培訓記錄 |
11
|
Quality Policy | 質(zhì)量方針 |
12
|
Quality Objective | 質(zhì)量目標 |
13
|
Quality Manual | 質(zhì)量手冊 |
14
|
Products Safety Procedure | 產(chǎn)品安全程序 |
15
|
Work Instruction | 作業(yè)指導書 |
16
|
Internal Audit Procedure & Records | 內(nèi)審程序/記錄 |
17
|
Management Review Procedure and Record | 管理評審程序/記錄 |
18
|
Reports of the Functioning of QMS Including Suggestions for Improvement | 有關質(zhì)量管理體系的業(yè)績及改進需求的報告 |
19
|
Products Specifications | 產(chǎn)品規(guī)范 |
20
|
Record of Customers Requirement Review | 顧客要求評審記錄 |
21
|
Document Control Procedure | 文件控制程序 |
22
|
Record Control Procedure | 記錄控制程序 |
23
|
Products Change Records | 產(chǎn)品變更記錄 |
24
|
Suppliers / Sub-contractor Control Procedure | 供應商/分包商控制程序 |
25
|
Suppliers / Sub-contractor List and Assessment Record | 合格供方(供應商,分包商)清單及審核記錄 |
26
|
CAPA Procedure and Record | 糾正預防措施程序/記錄 |
27
|
Testing Record for the Traceability System | 可追溯性體系測試記錄 |
28
|
Legal Statutes and Mandatory Standards Applicable to Products/ Materials | 產(chǎn)品,物料相關的法律法規(guī)和強制性標準(生產(chǎn)和擬銷售地區(qū)的) |
29
|
Products Risk Assessment Procedure/ Record | 產(chǎn)品風險評估程序/記錄 |
30
|
Process Control Procedure | 過程控制程序 |
31
|
Products Risk Assessment Review Record | 產(chǎn)品風險評估的評審記錄 |
32
|
Training Procedure/ Plan | 員工的培訓程序/計劃 |
33
|
Training Records (including Internal Rule and Work Skill training) | 員工的培訓記錄(規(guī)章制度,技能) |
34
|
Training Records for Products Risk Assessment Staff | 執(zhí)行風險評估人員的培訓記錄 |
35
|
Training Evaluation Record | 培訓有效性評估記錄 |
36
|
Customer Complain & feedback Procedure/ Records | 顧客抱怨反饋程序/記錄 |
37
|
Incident Handle Procedure & Record | 事故處理程序/記錄 |
38
|
Inside & Outside Communication System | 內(nèi)部/外部溝通機制 |
39
|
Inspection Instructions (IQC/IPQC/FQC) | 檢驗規(guī)范(原材料/過程/成品) |
40
|
Inspection Records (IQC/IPQC/FQC) | 檢驗記錄(原材料/過程/成品) |
41
|
Products Preservation Procedure, Temperature and Humidity Definition & Records (if applicable) | 產(chǎn)品防護程序,溫濕度規(guī)定及記錄 (若適用) |
42
|
Environment Policy | 環(huán)境方針 |
43
|
Environment Objective | 環(huán)境目標 |
44
|
Environment Impact Identified Procedure | 環(huán)境影響因素的識別程序 |
45
|
Documents Compliance With the Local Environment Law and Regulation | 符合當?shù)丨h(huán)保要求的文件(例如:環(huán)評報告/排污許可證/委托處理液廢/固廢處理方的營業(yè)執(zhí)照,雙方協(xié)議,資質(zhì)證明,發(fā)票/ 來自當?shù)卣姆闲陨昝鳎? |
46
|
Hazardous Waste Disposal Record | 有害廢棄物處理記錄 |
47
|
Non-conforming Products Control Procedure | 不合格品的控制程序 |
48
|
Non-conforming Products Review Record | 不合格品的評審記錄 |
49
|
Assessment/Review Records of Product Test Need | 測試需求評審記錄 |
50
|
Testing Procedure & Record | 產(chǎn)品的測試程序/記錄 |
51
|
Testing Report Provided by Accredited laboratory (In-house or 3rd party) | 有資質(zhì)的實驗室(內(nèi)部或第3方)提供的測試報告 |
52
|
Test Order/Request | 測試訂單/申請 |
53
|
Review & CAPA Record of Failed Test Result | 測試失敗的評審記錄及相應的糾正措施記錄 |
54
|
Re-inspection Records for the Re-worked Products | 返工重驗記錄 |
55
|
Recall Procedure/ Record | 召回程序/記錄 |
56
|
Pre-Production Meeting Records | 產(chǎn)前會議記錄 |
57
|
First Article Inspection Records | 首件確認記錄 |
58
|
Process Monitoring Procedure and record | 過程的監(jiān)視和測量程序/記錄 |
59
|
Measuring Machines/Equipments Calibration Plan and Records | 測量儀器的校準計劃/記錄 |
60
|
Shipment Release Instructions | 產(chǎn)品放行規(guī)定 |