1.1 工廠簡介 Brief introduction of factory
1.2 營業(yè)執(zhí)照 Business license
1.3 公司組織架構(gòu)圖 Organization chart
1.4 (公司)廠區(qū)/廠房平面圖 Factory’s plane figure-
factory floor plans
1.5 生產(chǎn)工序流程圖 Production process chart
2.1 ISO9000證書及最近一次外審報(bào)告ISO 9000 certificate
and the last external audit reports
2.2 質(zhì)量手冊 Quality manual
2.3 程序文件 Procedure
2.4 質(zhì)量計(jì)劃 Quality program
2.5 文件更改收發(fā)記錄 Documents control records
2.6 員工培訓(xùn)計(jì)劃 Worker training plan
2.7 員工質(zhì)量培訓(xùn)記錄 Worker quality training records
2.8 內(nèi)部審核計(jì)劃、記錄 Internal audit plan and records
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
2.10 客戶投訴處理記錄 Complaint handling procedure and
records
2.11 糾正與預(yù)防措施記錄 Records of corrective actions
and preventative actions
儀器設(shè)備清單、內(nèi)外校記錄報(bào)告Testing/measuring
equipments calibration records
2.12 設(shè)備維護(hù)計(jì)劃和記錄 Equipment maintainence plan and records
2.13 CE/EMC/相關(guān)的產(chǎn)品測試化驗(yàn)報(bào)告CE/ EMC/ Relevant
product lab test reports
2.14 其它相應(yīng)有效的安全證書Other corresponding valid
safety certificate
3.1 開發(fā)設(shè)計(jì)控制程序Design control procedure
3.2 設(shè)計(jì)計(jì)劃或任務(wù)書及審核記錄 Design planning and input review record
3.3 驗(yàn)證和確認(rèn)記錄 verification and validation records
3.4 設(shè)計(jì)產(chǎn)品檢測報(bào)告 design testing and record
3.6 設(shè)計(jì)變更記錄 （ECN）
4.1 供應(yīng)商評審程序及記錄Monitoring procedure and records of suppliers
4.2 供應(yīng)商清單/合格供應(yīng)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(chǎn)品的質(zhì)量保證書Quality guaranty for exempt from inspection of incoming material/Receiving and distribution
5.2 來料驗(yàn)貨標(biāo)準(zhǔn)及規(guī)格書IQC standard and specifications
5.3 來料檢查、測試報(bào)告 IQC reports
5.4 來料收發(fā)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(yè)指導(dǎo)書 Working instructions
6.2 巡拉記錄 In line inspection records
6.3 IPQC檢驗(yàn)測試標(biāo)準(zhǔn)、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(fā)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(yàn)測試標(biāo)準(zhǔn)、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(fā)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(fā)貨記錄 Release records
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