下面是MGB驗廠所需文件清單供大家參考：

01 Business License     營業(yè)執(zhí)照
02 Organization Chart    組織結(jié)構(gòu)圖
03 Key Staff Job Description & Duty Vicegerent      關(guān)鍵崗位的崗位職責(zé)/職務(wù)代理人
04 Production Flow Chart      生產(chǎn)流程圖
05 Equipment List                  設(shè)備清單
06 Machines Maintenance Plan & Records     設(shè)備保養(yǎng)計劃/記錄
07 Machines Repair Records      設(shè)備維修記錄
08 Equipment Operation Instructions      設(shè)備操作指引
09 Building/Equipment/ Products Cleaning Products and Records 廠房（內(nèi)，外部）/設(shè)備/產(chǎn)品的清潔程序/記錄
10 Training Records for Cleaning Staff 清潔人員的培訓(xùn)記錄
11 Quality Policy 質(zhì)量方針
12 Quality Objective 質(zhì)量目標(biāo)
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(dǎo)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(guān)質(zhì)量管理體系的業(yè)績及改進(jìn)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(yīng)商/分包商控制程序
25 Suppliers / Sub-contractor List and Assessment Record 合格供方（供應(yīng)商，分包商）清單及審核記錄
26 CAPA Procedure and Record 糾正預(yù)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(guān)的法律法規(guī)和強(qiáng)制性標(biāo)準(zhǔn)（生產(chǎn)和擬銷售地區(qū)的）
29 Products Risk Assessment Procedure/ Record 產(chǎn)品風(fēng)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(fēng)險評估的評審記錄
32 Training Procedure/ Plan 員工的培訓(xùn)程序/計劃
33 Training Records (including Internal Rule and Work Skill training) 員工的培訓(xùn)記錄（規(guī)章制度，技能）
34 Training Records for Products Risk Assessment Staff 執(zhí)行風(fēng)險評估人員的培訓(xùn)記錄
35 Training Evaluation Record 培訓(xùn)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(jī)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(hù)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(biāo)
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(dāng)?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(dāng)?shù)卣姆闲陨昝鳎?br /> 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(yīng)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(rèn)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(zhǔn)計劃/記錄
60 Shipment Release Instructions 產(chǎn)品放行規(guī)定

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