2024年3月28日发(作者：)
质量管理审核所需文件/
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
提供(Available)
YES NO N/A
复印(Copied)
YES NO
1.1工厂简介 Brief introduction of factory
1.2营业执照 Business license
1.3公司组织架构图 Organization chart
1.4(公司)厂区/厂房平面图 Factory’s plane figure-
factory floor plans
1.5生产工序流程图 Production process chart
2.1ISO9000证书及最近一次外审报告ISO 9000 certificate
and the last external audit reports
2.2质量手册 Quality manual
2.3程序文件 Procedure
2.4质量计划 Quality program
2.5文件更改收发记录 Documents control records
2.6员工培训计划 Worker training plan
2.7员工质量培训记录 Worker quality training records
2.8内部审核计划、记录 Internal audit plan and records
2.9订单评审和客户关注程序及记录 Order review and
customer focus procedure and records
2.10客户投诉处理记录 Complaint handling procedure and
records
2.11纠正与预防措施记录 Records of corrective actions
and preventative actions
2.12仪器设备清单、内外校记录报告Testing/measuring
equipments calibration records
2.13设备维护计划和记录 Equipment maintainence plan and
records
2.14产品测试化验报告/ Relevant product lab test reports
2.15其它相应有效的安全证书Other corresponding valid
safety certificate
2.16REACH相关培训资料、SVHC清单、符合性记录 REACH
related training materials, SVHC list，
2.17风险管理程序、记录, Risk management procedure，
record
2.18设备、人员、环境卫生管理程序和记录 Equipments,
personal, Hygiene procedure and records.
3.1开发设计控制程序Design control procedure
3.2设计计划或任务书及审核记录 Design planning and
input review record
3.3验证和确认记录 verification and validation records
3.4设计产品检测报告 design testing and record
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质量管理审核所需文件/
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
提供(Available)
YES NO N/A
复印(Copied)
YES NO
3.5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)
3.6设计变更记录 （ECN）
4.1供应商评审程序及记录Monitoring procedure and
records of suppliers
4.2供应商清单/合格供应商清单Suppliers list and
qualified supplier list
4.3采购单、采购合同 Purchase orders and purchase
contracts
5.1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
5.2来料验货标准及规格书IQC standard and specifications
5.3来料检查、测试报告 IQC reports
5.4来料收发记录Incoming material/Receiving and
distribution records
5.5不良品退货、让步接收记录 Control procedure and
concession records for defect goods
6.1作业指导书 Working instructions
6.2巡拉记录 In line inspection records
6.3IPQC检验测试标准、记录 IPQC inspection standard and
records
6.4不良品处理记录 Rejected goods control records
6.5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,
7.1终检检验测试标准、记录 FQC/OQC inspection
standard and reports/ Defect goods control records
7.3终检不良品处理记录 Rejected goods control records
7.4发货记录 Release records
2.2/2.3 应复印目录
备注
◇ 表示必须复印， 如未复印应备注
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