质量管理审核所需文件/证件清单

附件是质量管理审核所需文件/证件清单,即一般品质验厂需要提供审核的文件和证件清单,摘录内容如下:

(SGS)质量管理审核所需文件/证件清单
Request Document List(QMS Audit)

No. 项目与内容 Items
1、工厂简介 Brief introduction of factory
2、营业执照 Business license
3、公司组织架构图 Organization chart
4、(公司)厂区/厂房平面图 Factory’s plane figure-factory floor plans
5、生产工序流程图 Production process chart
6、ISO9000证书及最近一次外审报告ISO 9000 certificate and the last external audit reports
7、质量手册 Quality manual
8、程序文件 Procedure
9、质量计划 Quality program
10、文件更改收发记录 Documents control records
11、员工培训计划 Worker training plan
12、员工质量培训记录 Worker quality training records
13、内部审核计划、记录 Internal audit plan and records
14、订单评审和客户关注程序及记录 Order review and customer focus procedure and records
15、客户投诉处理记录 Complaint handling procedure and records
16、纠正与预防措施记录 Records of corrective actions and preventative actions
17、仪器设备清单、内外校记录报告Testing/measuring equipments calibration records
18、设备维护计划和记录 Equipment maintainence plan and records
19、CE/EMC/相关的产品测试化验报告CE/ EMC/ Relevant product lab test reports
20、其它相应有效的安全证书Other corresponding valid safety certificate
21、开发设计控制程序Design control procedure
22、设计计划或任务书及审核记录 Design planning and input review record
23、验证和确认记录 verification and validation records
24、设计产品检测报告 design testing and record
25、设计输出(技术文件,物料单, 包装、使用说明)Design output (technical file, BOM, Packing and using description)
26、设计变更记录 (ECN)
27、供应商评审程序及记录Monitoring procedure and records of suppliers
28、供应商清单/合格供应商清单Suppliers list and qualified supplier list
29、采购单、采购合同 Purchase orders and purchase contracts
30、来料中免检产品的质量保证书Quality guaranty for exempt from inspection of incoming material/Receiving and distribution records/Purchasing contracts
31、来料验货标准及规格书IQC standard and specifications
32、来料检查、测试报告 IQC reports
33、来料收发记录Incoming material/Receiving and distribution records
34、不良品退货、让步接收记录 Control procedure and concession records for defect goods
35、作业指导书 Working instructions
36、巡拉记录 In line inspection records
37、IPQC检验测试标准、记录 IPQC inspection standard and records
38、不良品处理记录 Rejected goods control records
39、组装线工具利器(刀片,断针等)收发控制记录Procedure for controlling the use and recovery of hand tools, knives, needles, etc
40、金属探测记录 Metal detection records in process
41、终检检验测试标准、记录
、Defect goods control records
42、终检不良品处理记录 Rejected goods control records
43、包装工段工具利器(刀片,断针等)收发控制记录 Procedure for controlling the use and recovery of hand tools, knives, needles, etc/Metal
44、终检金属探测记录 FQC/OQC Metal detection records
45、发货记录 Release records
备注、以上清单仅供参考,审核员会根据审核现场的实际情况决定是否需要工厂提供其他与审核相关的文件或免除部分文件。

附件:质量管理审核所需文件/证件清单

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