Metro麥德龍驗廠
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下面是MGB驗廠所需文件清單供大家參考:
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 Instructions 設備操作指引
09 BuildingEquipment 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 Suggestions for Improvement 有關質量管理體系的業績及改進需求的報告
19 Products Specifications 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 Instructions (IQCIPQCFQC) 檢驗規范(原材料過程成品)
40 Inspection Records (IQCIPQCFQC) 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
48 Non-conforming Products Review Record 不合格品的評審記錄
49 AssessmentReview Records of Product Test Need 測試需求評審記錄
50 Testing Procedure & Record 產品的測試程序記錄
51 Testing Report Provided by Accredited laboratory (In-house or 3rd party) 有資質的實驗室(內部或第3方)提供的測試報告
52 Test OrderRequest 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 過程的監視和測量程序記錄
59 Measuring MachinesEquipments Calibration Plan and Records 測量儀器的校準計劃記錄
60 Shipment Release Instructions 產品放行規定
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