实用标准文案精彩文档医疗器械质量管理体系文件(2017年版)实用标准文案精彩文档公司名称：***有限公司目录MH-YLQXZZ001质量管理职责...........................................................................1MH-YLQXZD-001质量管理的规定制度.............................................................5MH-YLQXZD-002疗器械供货商资格审核管理制度........................................7MH-YLQXZD-003医疗器械采购管理制度.........................................................9MH-YLQXZD-004医疗器械收货管理制度......................................................11MH-YLQXZD-005医疗器械验收管理制度......................................................13MH-YLQXZD-006医疗器械库房贮存管理制度.............................................15MH-YLQXZD-007医疗器械出库复核管理制度.............................................17MH-YLQXZD-008医疗器械销售管理制度......................................................19MH-YLQXZD-009医疗器械售后服务管理制度.............................................21MH-YLQXZD-010不合格医疗器械管理制度.................................................23MH-YLQXZD-011医疗器械退、换货管理制度.............................................25实用标准文案精彩文档MH-YLQXZD-012医疗器不良事件监测和报告管理制度.............................27MH-YLQXZD-013医疗器械召回规定管理制度.............................................30MH-YLQXZD-014设施设备验证、校准和维护管理制度.............................34MH-YLQXZD-015卫生和人员健康状况管理制度.........................................36MH-YLQXZD-016质量管理培训及考核管理制度.........................................38MH-YLQXZD-017质量投诉、事故调查和处理报告管理制度....................40MH-YLQXZD-018医疗器械追踪溯源管理制度.............................................43MH-YLQXZD-019质量管理制度执行情况考核管理制度.............................46MH-YLQXZD-020质量管理自查管理制度......................................................48MH-YLQXCX-001医疗器械资质审核程序......................................................52MH-YLQXCX-002医疗器械购进控制程序......................................................55MH-YLQXCX-003医疗器械收货控制程序......................................................58MH-YLQXCX-004医疗器械验收控制程序......................................................62MH-YLQXCX-005医疗器械入库储存程序......................................................64MH-YLQXCX-006医疗器械销售程序..............................................................66MH-YLQXCX-007医疗器械出库复核程序......................................................69MH-YLQXCX-008医疗器械运输程序..............................................................71MH-YLQXCX-009医疗器械拆零和拼装发货操作程序.................................75实用标准文案精彩文档MH-YLQXCX-010医疗器械退换货操作程序................................................77MH-YLQXCX-011医疗器械召回操作程序......................................................79MH-YLQXCX-012不合格医疗器械控制处理操作程序.................................84MH-YLQXCX-013有关记录和凭证管理程序..................................................87实用标准文案精彩文档MH-YLQXCX-014售后服务质量控制管理程序..............................................90MH-YLQXCX-015客户质量投诉、事故调查和处理报告程序.....................92MH-YLQXCX-016计算机系统的操作程序......................................................94MH-YLQXCX-017...
