安规验厂需准备的文件清单.docVIP

多年验厂辅导经验总结之验厂资料提纲概括 质量体系审核文件资料清单Documents List for QMS Audit1.? 营业执照 (Business Licenses);2.? 质量体系认证证书 (QMS certificate);3.? 组织架构图 (Organization Chart);4.? 质量手册 (Quality manual);5.? 程序文件 (Quality procedure);6.? 质量体系内审计划 (QMS internal audit plan);7.? 质量体系内审记录 (QMS internal audit records):1）内审员资格证书 (Internal auditor qualification certificate);2）首末次会议 (Opening meeting and close meeting records);3）检查表 (QMS internal audit checklist);4）不符合项报告 (QMS internal audit NC reports);5）内审报告 (QMS internal audit report)8.? 质量体系管理评审计划 (QMS management review plan)9.? 质量体系管理评审记录 (QMS management review records):1）管理评审会议记录 (QMS management review meeting record);2）管理评审报告 (QMS management review report);3）决议事项的跟进记录 (QMS management review decisions follow-up records)10. 主要生产设备清单 (Major production machinery list);11.设备保养计划 (Machinery maintenance schedule);12. 设备保养记录 (Machinery maintenance records);13. 仪器清单 (Test and measure equipment list);14. 仪器校准计划 (Test and measure equipment calibration schedule);15. 仪器校准记录 (Test and measure equipment calibration records):1）外校报告 (External calibration reports);2）内校人员资格证书 (Internal calibration personnel qualification)3）内校规程 (Internal calibration instruction);4）内校报告 (Internal calibration reports16. 年度培训计划 (Annual training plan)17.? 培训记录 (Training records):1） 签到表 (Training attendee signature);2）测试卷 (Training effectiveness verification records18.? 品管人员岗前资质认定资料（培训及测试记录）-Quality personnel certification records (including training and examination records);19.? 新产品设计开发资料 (New products design and development records):1）产品规格书 (Product specification);2） BOM表 (BOM);3）安规认证证书 (Safety certificate);4）样品检测报告 (Design samples test and inspection reports)5）试产记录 (Pilot runs record);6） 试产评估报告 (Pilot runs review records);7） 作业指导书 (Work instruction);8）检验标准 (Inspection standard);9） FMEA分析资料 (FMEA analysis report);10）产品质量控制计划（QC工程图）-Product quality control plan/chart.20.? 订单评审记录 (Order review records);21.? 新供应商资格评定报告 (New suppliers evalua