1.1 工廠簡介 Brief introduction of factory
1.2 營業執照 Business license
1.3 公司組織架構圖 Organization chart
1.4 (公司)廠區/廠房平面圖 Factory’s plane figure-
factory floor plans
1.5 生產工序流程圖 Production process chart
2.1 ISO9000證書及最近一次外審報告ISO 9000 certificate
and the last external audit reports
2.2 質量手冊 Quality manual
2.3 程序文件 Procedure
2.4 質量計劃 Quality program
2.5 文件更改收發記錄 Documents control records
2.6 員工培訓計劃 Worker training plan
2.7 員工質量培訓記錄 Worker quality training records
2.8 內部審核計劃、記錄 Internal audit plan and records
2.9 訂單評審和客戶關注程序及記錄 Order review and
customer focus procedure and records
2.10 客戶投訴處理記錄 Complaint handling procedure and
records
2.11 糾正與預防措施記錄 Records of corrective actions
and preventative actions
儀器設備清單、內外校記錄報告Testing/measuring
equipments calibration records
2.12 設備維護計劃和記錄 Equipment maintainence plan and records
2.13 CE/EMC/相關的產品測試化驗報告CE/ EMC/ Relevant
product lab test reports
2.14 其它相應有效的安全證書Other corresponding valid
safety certificate
3.1 開發設計控制程序Design control procedure
3.2 設計計劃或任務書及審核記錄 Design planning and input review record
3.3 驗證和確認記錄 verification and validation records
3.4 設計產品檢測報告 design testing and record
3.6 設計變更記錄 （ECN）
4.1 供應商評審程序及記錄Monitoring procedure and records of suppliers
4.2 供應商清單/合格供應商清單Suppliers list andqualified supplier list
4.3 采購單、采購合同 Purchase orders and purchase contracts
5.1 來料中免檢產品的質量保證書Quality guaranty for exempt from inspection of incoming material/Receiving and distribution
5.2 來料驗貨標準及規格書IQC standard and specifications
5.3 來料檢查、測試報告 IQC reports
5.4 來料收發記錄Incoming material/Receiving and distribution records
5.5 不良品退貨、讓步接收記錄 Control procedure and concession records for defect goods
6.1 作業指導書 Working instructions
6.2 巡拉記錄 In line inspection records
6.3 IPQC檢驗測試標準、記錄 IPQC inspection standard and records
6.4 不良品處理記錄 Rejected goods control records
6.5 組裝線工具利器(刀片，斷針等)收發控制記錄Procedure for controlling the use and recovery of hand tools,
6.6 金屬探測記錄 Metal detection records in process
7.1 終檢檢驗測試標準、記錄 FQC/OQC inspection
standard and reports/ Defect goods control records
7.2 終檢不良品處理記錄 Rejected goods control records
7.3 包裝工段工具利器(刀片，斷針等)收發控制記錄Procedure for controlling the use and recovery of
7.4 終檢金屬探測記錄 FQC/OQC Metal detection records
7.5 發貨記錄 Release records
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