质量管理审核所需文件/证件清单

质量管理审核所需文件/证件清单

Request Document List (QMS Audit)

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

2.1 ISO9000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

仪器设备清单、内外校记录报告Testing/measuring

equipments calibration records

2.12 设备维护计划和记录 Equipment maintainence plan and records

2.13 CE/EMC/相关的产品测试化验报告CE/ EMC/ Relevant

product lab test reports

2.14 其它相应有效的安全证书Other corresponding valid

safety certificate

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