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序號 DOCUMENT 文件
01 Business License
營業執照
02 Organization Chart
組織結構圖
03 Key Staff Job Description & Duty Vicegerent
關鍵崗位的崗位職責/職務代理人
04 Production Flow Chart
生產流程圖
05 Equipment List
設備清單
06 Machines Maintenance Plan & Records
設備保養計劃/記錄
07 Machines Repair Records
設備維修記錄
08 Equipment Operation Instructi*****
設備操作指引
09 Building/Equipment/ Products Cleaning Products and Records
廠房(內,外部)/設備/產品的清潔程序/記錄
10 Training Records for Cleaning Staff
清潔人員的培訓記錄
11 Quality Policy
質量方針
12 Quality Objective
質量目標
13 Quality Manual
質量手冊
14 Products Safety Procedure
產品安全程序
15 Work Instruction
作業指導書
16 Internal Audit Procedure & Records
內審程序/記錄
17 Management Review Procedure and Record
管理評審程序/記錄
18 Reports of the Functioning of QMS Including Suggesti***** for Improvement
有關質量管理體系的業績及改進需求的報告
19 Products Specificati*****
產品規范
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
產品,物料相關的法律法規和強制性標準(生產和擬銷售地區的)
29 Products Risk Assessment Procedure/ Record
產品風險評估程序/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(規章制度,技能)
34 Training Records for Products Risk Assessment Staff
執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
內部/外部溝通機制
39 Inspection Instructi***** (IQC/IPQC/FQC)
檢驗規范(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)
產品防護程序,溫濕度規定及記錄 (若適用)
42 Environment Policy
環境方針
43 Environment Objective
環境目標
44 Environment Impact Identified Procedure
環境影響因素的識別程序
45 Documents Compliance With the Local Environment Law and Regulation
符合當地環保要求的文件(例如:環評報告/排污許可證/委托處理液廢/固廢處理方的營業執照,雙方協議,資質證明,發票/ 來自當地政府的符合性申明)
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 |
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