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2022年医疗器械质量管理制度大全 .pdf

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1、质量管理制度目录一、各级人员岗位职责1、分管经理岗位职责 2 2、质量管理部工作职责 3 3、质量管理部经理岗位职责4 4、质量管理员岗位职责 5 5、采购员岗位职责6 6、质量验收员岗位职责 7 7、养护保管人员岗位职责 8 8、出库复核人员岗位职责 9 9、营业员岗位职责 10 二、医疗器械质量管理制度文件1、产品购进管理制度 11 2、产品销售管理制度 13 3、产品进货验收制度 14 4、产品仓库保管制度 15 5、产品在库养护制度 16 6、产品出库复核制度 17 7、效期产品管理制度 18 8、不合格产品管理制度 19 9、医疗器械质量跟踪和不良反应报告制度20 10、售后服务管理

2、制度21 11、人员学习培训制度22 12、质量投诉、查询管理制度23 13、文件、资料、记录管理制度24 14、卫生及人员健康管理制度25 15、质量验收程序26 16、仓库管理及在库养护操作程序27 分管经理岗位职责一、负责医疗器械经营的全面工作，认真贯彻执行国家有关医疗器械的法律、法规及行政规章。遵纪守法，依法经营，照章纳税。二、对所经营的医疗器械的质量负领导责任、民事责任和经济法律责任。负责组织实施本企业制定的各项质量管理制度。监督、检查、考核完成情况。确保医疗器械的安全、有效。三、认真做好企业员工的业务学习和培训，提高员工的职业道德及专业技术水平，做好各项服务工作，树立企业良好信誉形

3、象。四、抓好综合治理，搞好店容店貌、环境卫生、安全保卫、防火防盗等项工作，确保企业正常运行。文件名称：分管经理岗位职责编号：BZYY QD0012010-00 版本号：00 起草人张宏伟起草日期2010.09.01 审核人张晨阳审核日期2010.09.20 批准人张广菊批准日期2010.09.30 生效日期2010.10.20 变更记录：变更原因：文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编

4、码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E

5、1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编

6、码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E

7、1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编

8、码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E

9、1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1质量管

10、理部工作职责一、认真贯彻执行医疗器械监督管理条例及相关法律、法规及行政规章。协助经理做好本企业医疗器械的质量管理工作。二、负责本企业医疗器械质量管理规章制度的制定和实施；定期检查采购、仓储、销售人员等部门执行质量管理制度的情况；协助企业领导建立各部门质量负责人及有关人员参加的质量管理网络，沟通质量信息；分析研究质量管理工作中存在的问题，提出改进措施。三、熟悉所经营医疗器械质量标准，负责对医疗器械经营活动中的质量审核，有选择性地对一次性使用无菌医疗器械供应商进行质量保证体系的调查、审核，以保证购入产品质量。四、负责处理来自客户和患者对医疗器械的质量查询，根据用户对医疗器械质量的信息反馈，分析存在

11、的问题，需要多部门处理的，由主管经理协调解决。发现假劣产品或质量可疑产品，必须及时报告当地药品监督管理部门，不得自行做销售或退换货处理。五、建立三类医疗器械质量档案，做到对每个产品从采购、储存、销售到售后追踪管理。六、负责管理各类医疗器械质量信息；定期收集和分析来自药品监督管理部门、检验部门有关质量方面的文件、检验报告以及报纸期刊提供的质量信息，并加以编辑整理供领导决策和为采购提供信息，并按规定向有关部门上报反馈信息，及时向药品监督管理部门报告不良反应及重大质量事故，并在药品监督管理部门指导下妥善处理各种质量事故。七、指导医疗器械养护、保管、运输人员按产品性能合理储存和运输。八、负责质量不合格

12、医疗器械销毁前的审核及销毁产品处理的监督工作并做好销毁记录。文件名称：质量管理部工作职责编号：BZYY QD0022010-00 版本号：00 起草人张宏伟起草日期2010.09.01 审核人张晨阳审核日期2010.09.20 批准人张广菊批准日期2010.09.30 生效日期2010.10.20 变更记录：变更原因：文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 H

13、N4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7

14、Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 H

15、N4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7

16、Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 H

17、N4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7

18、Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1九、配合教育部门开展医疗器械的业务技

19、术培训并负责医疗器械质量的技术咨询。质量管理部经理岗位职责一、在分管经理的领导下，主持质量管理科的全面工作，对公司所经营医疗器械的质量负责。二、负责起草质量管理制度并组织实施，监督检查制度执行情况。三、协助分管经理做好人员培训与考核工作，不断提高员工的质量意识及工作效率。四、定期主持召开质量分析会，及时传达有关质量信息，收集、整理所经营产品的质量信息，及时提出改进意见。五、有权制止未经验收不合格的产品入库，并提出处理意见。六、有权制止在销售过程中发现的不合格品及失效产品出库，并提出处理意见。七、对本企业发生的质量事故，因违反质量法规而造成事故的责任者，有权追查原因，并提出处理意见。八、完成经理

20、交办的其他工作。文件名称：质量管理部经理岗位职责编号：BZYY QD0032010-00 版本号：00 起草人张宏伟起草日期2010.09.01 审核人张晨阳审核日期2010.09.20 批准人张广菊批准日期2010.09.30 生效日期2010.10.20 变更记录：变更原因：文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7

21、Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 H

22、N4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7

23、Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 H

24、N4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7

25、Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 H

26、N4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1质量管理员岗位职责一、树立“质量第一”的思想，协助质管部长做好质量管理及质量

27、教育工作。二、认真学习医疗器械质量相关的法律、法规、行政规章及专业知识，对医疗器械质量进行严格的监督管理。三、履行质量领导小组职责，配合有关部门做好每季度质量制度的检查考核工作。四、负责本部门的质量资料归档工作。五、负责质量信息的管理工作，经常收集各种医疗器械质量信息及质量意见和建议，组织传递反遗，并做好分析、上报工作。六、负责计量管理工作，对使用的计最器具建立帐卡文件名称：质量管理员岗位职责编号：BZYY QD0042010-00 版本号：00 起草人张宏伟起草日期2010.09.01 审核人张晨阳审核日期2010.09.20 批准人张广菊批准日期2010.09.30 生效日期2010.

28、10.20 变更记录：变更原因：文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码

29、:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1

30、W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码

31、:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1

32、W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码

33、:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1

34、W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1采购员岗位职责五、必须购进经过注册、有合格证明的医疗器械产品，收集并保存所经营产品的注册证、备案表的复印件及相关国家标准、行业标准的有效版本。同时做好购进记录，记录保存至产品有效期满后二年备查。六、对购进进口产品，应有中文标识及产品说明书，并经国家食品药品监督管理局批准的合法证明文件(注册证)。购进首次进口的医疗器械，应该向国

35、家食品药品监督管理局提供该产品的说明书、质量标准、检验方法等有关资料和样品以及出口国(地区)批准生产销售及证明文件，经审批注册，领取进口注册证书后向海关申请办理进口手续。七、不得从无医疗器械生产许可证或者无医疗器械经营许可证的企业购进医疗器械。八、不得购进未经注册、无合格证明、过期、失效或者淘汰的医疗器械及国家食品药品监督管理部门禁止使用的医疗器械。九、购进医疗器械必须有合法的原始票据、凭证和购进记录，认真填写购进医疗器械记录，做到票、帐、物相符。业务、财物、储运三帐相符。十、购进医疗器械各种原始票据、凭证、合同、协议书、记录等必须建立档案，妥善保存三年以上。十一、采购部负责医疗器械的购进工作

36、。文件名称：采购员岗位职责编号：BZYY QD0052010-00 版本号：00 起草人张宏伟起草日期2010.09.01 审核人张晨阳审核日期2010.09.20 批准人张广菊批准日期2010.09.30 生效日期2010.10.20 变更记录：变更原因：文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R

37、3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7

38、ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R

39、3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7

40、ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R

41、3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7

42、ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1质量验收员岗位职责一、严格按照法定现行质量标准和合同规定的质量条款对企业购入的医疗器械进行逐批验收

43、，验收合格的准许入库，不合格的不得入库。二、验收医疗器械质量应检查以下内容：1、由生产企业质量检验机构签发的加盖本企业印章的医疗器械检验合格证；对于一次性使用无菌医疗器械，应向原生产企业索取按批次的检验报告书，加盖本企业红色印章，必要时，也可以抽样送检验部门检验。文件名称：质量验收员岗位职责编号：BZYY QD0052010-00 版本号：00 起草人张宏伟起草日期2010.09.01 审核人张晨阳审核日期2010.09.20 批准人张广菊批准日期2010.09.30 生效日期2010.10.20 变更记录：变更原因：文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5

44、Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7

45、 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5

46、Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7

47、 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5

48、Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7

49、 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5

50、Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y1文档编码:CV6R3G6A1V7 HN4S3E1W2L7 ZZ2M7M5Z7Y12、重点验收产品的标识，外观质量和包装质量是否符合相关标准的规定。对验收合格品填写入库验收记录，与保管员办理接交手续；对于不合格品填写拒收通知单，经质量管理部审核后，放入不合格区。规范填写验收记录，内容真实可靠，项目齐全，签字负责，按规定保存、备查。3、加盖供货企业红色公章的医疗器械经营企业许可证的复印件及营业执照复印件，加盖企业公章和企业法定代表人印章或签字的销售人员的委托授权书原件。三、对顾客退回的医疗器械产品，进行核实性验

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