医疗器械质量管理记录备案样册编制：审核：批准：目录年度培训计划..............................................................4员工培训记录表..................................................................5员工培训考核表..................................................................6员工个人培训教育档案............................................................7年度员工健康检查汇总表..........................................................8员工健康档案....................................................................9文件发放、回收记录.............................................................10文件修订申请表.................................................................11文件销毁审批记录...............................................................12合格供货方档案表...............................................................13医疗器械质量档案表.............................................................14首营企业审批表.................................................错误！未定义书签。首营品种审批表.................................................................16医疗器械采购订单........................................................17医疗器械验收记录........................................................18医疗器械停售通知单.............................................................19解除停售通知单.................................................................20医疗器械质量复查报告单.........................................................21不合格医疗器械台账.............................................................22不合格医疗器械报损审批表.......................................................23报损医疗器械清单...............................................................24医疗器械销毁记录...............................................................25设备管理台账.........................................................26养护设备使用记录...............................................................27养护设备检修维护记录...........................................................28强制检定计量器具检定记录卡.....................................................29近效期医疗器械催销表...........................................................30销后退回单.............................................................31医疗器械陈列/储存环境温湿度记录表..............................................32陈列医疗器械养护记录..................................................33医疗器械养护档案...............................................................34医疗器械销售记录........................................................35医疗器械质量查询记录表.........................................................36顾客投诉受理记录...............................................................37售后质量问题追踪表.............................................................38医疗器械不良反应/事件报告表...........................................39质量管理制度执行情况检查表.....................................................40员工培训签到表.................................................................41养护质量信息汇总表.............................................................42质量信息收集..............................................................43质管员对医疗器械采购、收货、验收、保管、养护、工作监督管理指导记录.............44质量事故报告分析..............
