ADEO验厂咨询-全流程质量管控文件篇:从体系搭建到结果验证的质量文件链
General
1. Company brief introduction 公司概括简介—人员/产量/产值/(品牌)市场分布
2. Business license 营业执照
3. Organization chart 公司组织架构图-(相关人员名片)
4. Factory Map(公司)厂区/厂房平面图
Quality Compliance
1. ISO9001 certificate and other certificate if any, ISO9001 证书或其它体系证书,若有
2. Quality manual / management procedures 质量手册,管理程序
3. Quality plan and objective 质量计划和质量目标
4. Incoming Quality Control Procedure/standard and records 进料质量控制程序/标准及其记录
5. Process Quality Control Procedure/standard and records 过程质量控制程序/标准及其记录
6. Final Quality Control Procedure/standard and records 最终质量控制程序/标准及其记录
7. Customer complaints procedure and records 客户投诉处理程序及其记录
8. Non-conformity products control procedure and records 不合格品控制程序及其记录
9. Internal audit control procedure and records 内部审核控制程序及其记录
10. Management review procedure and records 管理评审程序及记录
11. Document management procedure and records 文件管理程序及相关记录
12. Controlled document list 受控文件清单

13. Corrective and preventive actions control procedure and records 纠正和预防措施控制程序及其记录
14. REACH pre-registration record, 预注册记录 if any REACH,若有
15. Supplier management procedure and records 供应商管理程序及其记录
16. Supplier list( back up supplier if any) 供应商清单(是否有备用供应商)
17. Supplier evaluation process and relevant evaluation records 供应商评估流程及记录
18. Material purchasing order 物料采购合同
19. List of raw materials 原材料清单
20. Concession release process and records 让步放行流程及记录
21. Technical files for raw materials (specification, test reports, MSDS …) 原料的技术文件(规格书、测试报告、 MSDS 等)
22. Production flow chart 生产流程图
23. Production specification 产品的规格书
24. Operation/work instructions 作业指导书
25. Equipment list 设备清单
26. Repairing & maintaining records of machines 机器维修保养记录
27. Measuring & testing tools list 测量设备清单
28. Maintenance and calibration policy and records 维护校准的原则及其记录
29. Training plan 培训计划

30. Training records 培训记录
31. Assessment records for QCs and testing staffs 检验员和测试员的考核记录
32. Cleaning and disinfecting procedure 清洁及消毒程序
33. Customer satisfaction survey record 客户满意度调查记录。
34. Product risk assessment record 产品风险评估表
35. Product quality control plan 产品质量控制计划
36. Traceability test report 产品追溯性测试报告
37. Product EN standard or regulation if any 产品 EN 标准或法规,若有
38. Product 3rd test contract, test report and certificate 产品第三方测试协议、报告和证书
39. Product internal lab test report 产品内部实验室测试报告
40. Sales order from current customer 现有客户的销售合同
41. Product special requirement from customer if any,客户对产品的特殊要求,若有
42. Production order for current customer 现有客户的生产订单表
43. Change management procedure & records 变更管理程序文件和记录
44. Criss management procedure(Quality) 危机管理(质量相关)
45. Project document package 项目整套文件
























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