2018医院医疗器械高质量管理系统规章制度总汇编.pdf

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1、word 0/37 医疗器械质量管理制度word 1/37*医院XX医院关于成立医疗器械质量管理小组的通知各科室：为加强本医疗机构医疗器械管理，保证广阔患者使用医疗器械安全有效，依据医疗器械监视管理条例、医疗器械使用质量监视管理方法等有关法规、规章制定本规定。一、成立医院医疗器械质量管理小组组长：XXX 副组长：XXX 成员：医务科负责人、药剂科负责人、采购员、验收员、库管员、护理部负责人、质控办、各临床科室等医疗器械使用相关科室负责人文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3

2、文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5

3、H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3

4、文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5

5、H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3

6、文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5

7、H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3

8、文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3word 2/37 二、办事机构医疗器械质量管理小组办公室设在药剂科，归属于药物治疗学与药事管理委员会下管理。由药剂科负责医疗器械采购工作、处理日常工作，每季度对医疗器械工作开展情况汇总后在季度药事管理委员会上进展通报，每年度对医疗器械质量管理情况进展全面自查，并自查报告上报药事管理委员会审核，通过后上报旗市场监视管理局。医务科、总务科、质控办、护理部等科室负责医疗器械相关的管理工作。三、医疗器械质量管理小组职责一负责起草和制定本医院的医疗器械质量管理制度，指导、督促医疗器械管理工作，定期组织考核。二负责制定相关人

9、员的继续教育和培训计划，具体落实采购、验收、养护、使用人员的培训工作。三负责组织医疗器械监视管理法律、法规的学习培训和收集药品监视管理部门发布的医疗器械监管信息，研究医疗器械的质量管理工作。四对本医院使用医疗器械的质量负责，对首次采购的企业和产品进展资格合法性和产品合法性、安全性审查。五负责医疗器械质量投诉、不良事件等信息的收集和处理，作好记录，查明原因，与时报告有关部门。文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1

10、N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2

11、U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1

12、N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2

13、U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1

14、N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2

15、U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1

16、N6X4O6O3word 3/37 附件：1、医疗器械各项管理制度2、各项管理表格XX医院年月日目录1、医疗器械临床准入与评价管理制度2、医疗器械采购制度3、首次购进企业品种质量审核制度4、医疗器械进货检查验收制度5、医疗器械储存、保管、养护制度6、医疗器械出库复核制度文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:

17、CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E

18、3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:

19、CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E

20、3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:

21、CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E

22、3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3word 4/37 7、效期医疗器械管理制度8、不合格医疗器械管理制度9、医疗器械不良事件

23、报告制度10、医疗器械维修保养工作制度11、医疗器械使用管理规定12、植入(介入)性卫生材料管理制度13、医疗器械正常破损报废制度14、一次性使用无菌医疗器械管理制度15、卫生和人员健康状况管理制度16、质管人员培训制度文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 Z

24、T1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8

25、H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 Z

26、T1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8

27、H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 Z

28、T1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8

29、H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3word 5/37 医疗器械临床准入与评价管理制度一、各业务科室根据临床工作需要按年度编报设备计划，10 万元以上设备应填写计划论证表，由总

30、务科汇总后，交医疗器械临床使用安全管理委员会讨论，形成年度计划，并由院领导批准后执行。二、购置大型医疗设备，必须先编写可行性报告与大型医疗设备配置申请表，报省卫生部门批准后执行。三、对紧急情况或临床急需的医设备，应由使用科室提出申请，按审批规定，经院领导批准后，优先办理。四、各业务科室不得对外签定订购合同或向厂商承诺购置意向。五、各类设备所需的耗材、配件应做好计划，由总务科审核，报分管领导批准执行。六、对于赠送的医疗设备，必须按程序办理相关手续，并经设备和医疗管理部门审核，经院领导批准后执行。如违反规定，造成的医疗事故或医患纠纷，由当事人承当有关的责任。文档编码:CQ5L8H2U3E3 HG5

31、H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3

32、文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5

33、H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3

34、文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5

35、H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3

36、文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5

37、H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3word 6/37 医疗器械采购制度为认真贯彻执行医疗器械监视管理条例、合同法、医疗器械使用质量监视管理方法等法律、法规和医院的各项质量管理制度，严格把好医疗器械购进质量关，确保依法购进并保证医疗器械产品质量，特制定本制度。一、医疗器械应当由药剂科实行统一采购，临床科室不得自行采购。二、严格坚持“按需进货，择优采购，质量第一的原如此。在采购时应选择合格供货方，对供货方的法定资格，履约能力，质量信誉

38、等应进展调查和评价，并建立合格供货方档案。三、采购应制定计划，并有质量管理机构人员参加，应签订书面采购合同。明确质量条款。采购合同如果不是以书面形式确立的，购销双方应提前签订注明各自质量现任的质量保证协议书。协议书应明确有效期。医疗设备的购进应当有检测、维修和保养条款。四、购进的医疗器械必须有产品注册号、产品包装和标志应符合有关规定。工商、购销合同与进口医疗器械合同上注明质量条款与标准。五、质量管理员应做好首营企业和首营品种的审核工作，审核时应查明以下加盖供方公章的证件、材料，并建立档案：1、医疗器械生产企业许可证或医疗器械经营企业许可证；文档编码:CQ5L8H2U3E3 HG5H3O4E3K

39、1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ

40、5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K

41、1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ

42、5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K

43、1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ

44、5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K

45、1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3word 7/37 2、医疗器械产品注册证书与附件；3、营业执照；4、企业法定代表人的委托授权书原件，委托授权书应明确授权X围；5、销售人员某某明；六、购进医疗器械产品应开据合法票据，并按规定建立购进记录，做到票、帐、货相符。票据和记录应按规定妥善保管。七、采购医疗器械时不得有如下行为：1、从无医疗器械生产企业许可证或医疗器械经营企业许可证、第二类医疗器械经营备案凭证的企业购进医疗器械；2、购进小包装已破损、标

46、识不清的无菌器械；3、购进未经注册、无合格证明、过期、失效或者淘汰的医疗器械；八、应与时了解医疗器械的库存结构情况，合理制定业务购进计划，在保证满足需求的前提下，防止医疗器械因积压过期失效或滞销造成的损失。文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O

47、6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3

48、HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O

49、6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3

50、HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O6O3文档编码:CQ5L8H2U3E3 HG5H3O4E3K1 ZT1N6X4O