以下是FCCA質(zhì)量管理審核所需文件/證件清單，供參考

1、工廠簡(jiǎn)介 Brief introduction of factory

2、營(yíng)業(yè)執(zhí)照 Business license

3、公司組織架構(gòu)圖 Organization chart

4、(公司)廠區(qū)/廠房平面圖 Factory’s plane figure-factory floor plans

5、生產(chǎn)工序流程圖 Production process chart

6、ISO9000證書及最近一次外審報(bào)告ISO 9000 certificate and the last external audit reports

7、質(zhì)量手冊(cè) Quality manual

8、程序文件 Procedure

9、質(zhì)量計(jì)劃 Quality program

10、文件更改收發(fā)記錄 Documents control records

11、員工培訓(xùn)計(jì)劃 Worker training plan

12、員工質(zhì)量培訓(xùn)記錄 Worker quality training records

13、內(nèi)部審核計(jì)劃、記錄 Internal audit plan and records

14、訂單評(píng)審和客戶關(guān)注程序及記錄 Order review and customer focus procedure and records

15、客戶投訴處理記錄 Complaint handling procedure and records

16、糾正與預(yù)防措施記錄 Records of corrective actions and preventative actions

17、儀器設(shè)備清單、內(nèi)外校記錄報(bào)告Testing/measuring equipments calibration records

18、設(shè)備維護(hù)計(jì)劃和記錄 Equipment maintainence plan and records

19、CE/EMC/相關(guān)的產(chǎn)品測(cè)試化驗(yàn)報(bào)告CE/ EMC/ Relevant product lab test reports

20、其它相應(yīng)有效的安全證書Other corresponding valid safety certificate

21、開發(fā)設(shè)計(jì)控制程序Design control procedure

22、設(shè)計(jì)計(jì)劃或任務(wù)書及審核記錄 Design planning and input review record

23、驗(yàn)證和確認(rèn)記錄 verification and validation records

24、設(shè)計(jì)產(chǎn)品檢測(cè)報(bào)告 design testing and record

25、設(shè)計(jì)輸出（技術(shù)文件，物料單， 包裝、使用說(shuō)明）Design output (technical file, BOM, Packing and using description)

26、設(shè)計(jì)變更記錄 （ECN）

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