質(zhì)量管理審核所需文件/證件清單
編輯:中國驗廠網(wǎng) 來源:中國驗廠網(wǎng) 日期: 2007-12-06 09:40:28
質(zhì)量管理審核所需文件/證件清單 | |||
Request Document List (QMS Audit) | |||
No. |
項目與內(nèi)容 Items |
提供(Available) |
復(fù)印(Copied) |
YES NO N/A |
YES NO | ||
1.1 |
工廠簡介 Brief introduction of factory |
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1.2 |
營業(yè)執(zhí)照 Business license |
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1.3 |
公司組織架構(gòu)圖 Organization chart |
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1.4 |
(公司)廠區(qū)/廠房平面圖 Factory’s plane figure-factory floor plans |
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1.5 |
生產(chǎn)工序流程圖 Production process chart |
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2.1 |
ISO9000證書及最近一次外審報告ISO 9000 certificate and the last external audit reports |
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2.2 |
質(zhì)量手冊 Quality manual |
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2.3 |
程序文件 Procedure |
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2.4 |
質(zhì)量計劃 Quality program |
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2.5 |
文件更改收發(fā)記錄 Documents control records |
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2.6 |
員工培訓(xùn)計劃 Worker training plan |
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2.7 |
員工質(zhì)量培訓(xùn)記錄 Worker quality training records |
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2.8 |
內(nèi)部審核計劃、記錄 Internal audit plan and records |
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2.9 |
訂單評審和客戶關(guān)注程序及記錄 Order review and customer focus procedure and records |
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2.10 |
客戶投訴處理記錄 Complaint handling procedure and records |
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2.11 |
糾正與預(yù)防措施記錄 Records of corrective actions and preventative actions |
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儀器設(shè)備清單、內(nèi)外校記錄報告Testing/measuring equipments calibration records |
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2.12 |
設(shè)備維護計劃和記錄 Equipment maintainence plan and records |
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2.13 |
CE/EMC/相關(guān)的產(chǎn)品測試化驗報告CE/ EMC/ Relevant product lab test reports |
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2.14 |
其它相應(yīng)有效的安全證書Other corresponding valid safety certificate |
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3.1 |
開發(fā)設(shè)計控制程序Design control procedure |
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3.2 |
設(shè)計計劃或任務(wù)書及審核記錄 Design planning and input review record |
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3.3 |
驗證和確認記錄 verification and validation records |
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3.4 |
設(shè)計產(chǎn)品檢測報告 design testing and record |
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3.5 |
設(shè)計輸出(技術(shù)文件,物料單, 包裝、使用說明) |
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3.6 |
設(shè)計變更記錄 (ECN) |
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4.1 |
供應(yīng)商評審程序及記錄Monitoring procedure and records of suppliers |
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4.2 |
供應(yīng)商清單/合格供應(yīng)商清單Suppliers list and qualified supplier list |
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4.3 |
采購單、采購合同 Purchase orders and purchase contracts |
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5.1 |
來料中免檢產(chǎn)品的質(zhì)量保證書Quality guaranty for exempt from inspection of incoming material/Receiving and distribution records/Purchasing contracts |
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5.2 |
來料驗貨標(biāo)準(zhǔn)及規(guī)格書IQC standard and specifications |
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5.3 |
來料檢查、測試報告 IQC reports |
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5.4 |
來料收發(fā)記錄Incoming material/Receiving and distribution records |
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5.5 |
不良品退貨、讓步接收記錄 Control procedure and concession records for defect goods |
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6.1 |
作業(yè)指導(dǎo)書 Working instructions |
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6.2 |
巡拉記錄 In line inspection records |
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6.3 |
IPQC檢驗測試標(biāo)準(zhǔn)、記錄 IPQC inspection standard and records |
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6.4 |
不良品處理記錄 Rejected goods control records |
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6.5 |
組裝線工具利器(刀片,斷針等)收發(fā)控制記錄Procedure for controlling the use and recovery of hand tools, knives, needles, etc |
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6.6 |
金屬探測記錄 Metal detection records in process |
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7.1 |
終檢檢驗測試標(biāo)準(zhǔn)、記錄 FQC/OQC inspection standard and reports/ Defect goods control records |
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7.2 |
終檢不良品處理記錄 Rejected goods control records |
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7.3 |
包裝工段工具利器(刀片,斷針等)收發(fā)控制記錄 Procedure for controlling the use and recovery of hand tools, knives, needles, etc/Metal detection records at packing stage |
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7.4 |
終檢金屬探測記錄 FQC/OQC Metal detection records |
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7.5 |
發(fā)貨記錄 Release records |
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備注 |
2.2/2.3 應(yīng)復(fù)印目錄 |
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