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2022年医疗器械经营企业管理制度 .pdf

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1、医疗器械质量管理制度目录文件名称文件编号医疗器械首营企业和首营品种质量审核制度 HZqx.QM.001.01 医疗器械购进管理制度 HZqx.QM.002.01 医疗器械质量验收制度 HZqx.QM.003.01 医疗器械在库保管、养护管理制度 HZqx.QM.004.01 医疗器械出库复核管理制度 HZqx.QM.005.01 医疗器械销售管理制度 HZqx.QM.006.01 效期医疗器械管理制度 HZqx.QM.007.01 不合格医疗器械管理制度 HZqx.QM.008.01 医疗器械质量跟踪制度 HZqx.QM.009.01 医疗器械不良事件报告制度 HZqx.QM.010.01 医

2、疗器械质量管理文件管理规定 HZqx.QM.011.01 有关记录和凭证管理制度 HZqx.QM.012.01 医疗器械质量查询和质量投诉管理制度 HZqx.QM.013.01 用户访问规定 HZqx.QM.014.01 质量信息管理制度 HZqx.QM.015.01 卫生和人员健康状况管理制度 HZqx.QM.016.01 一次性使用无菌医疗器械质量管理制度 HZqx.QM.017.01 质量教育培训及考核管理制度 HZqx.QM.018.01 仓库安全防火管理规定 HZqx.QM.019.01 岗位质量职责考核奖惩管理规定 HZqx.QM.020.01 质量事故报告制度 HZqx.QM.0

3、21.01.医疗器械退货质量管理制度 HZqx.QM.022.01 医疗器械运输管理制度 HZqx.QM.023.01 文件名称医疗器械首营企业和首营品种质量审核制度起草部门质管部文件编码 HZqx.QM.001.01起草：年月日审核：年月日批准：年月日执行日期：年月日变更记录：变更原因及目的：医疗器械首营企业和首营品种质量审核制度一、首营企业：指购进时，与本企业首次发生供需关系的医疗器械生产企业或经营企业。首营品种：指本企业向某医疗器械生产企业首次购进的医疗器械。包括新型号、新规格、新包装。二、首营企业审核内容：（一）审核供货企业是否持有医疗器械生产许可证、卫生许可证或医疗器械经营许可

4、证、营业执照等。（二）审核证照中生产或经营范围是否与供应的品种范围相符。（三）对企业的销售人员的身份进行审核。看是否具有法人授权委托书并提供身份证复印件等（四）审核是否具备质量保证能力，签订质量保证协议。三、首营企业质量保证能力有疑问时，采购部应会同质管部进行实地考察。四、首营品种审核内容为：医疗器械产品注册证、医疗器械产品生产制造认可表、注册产品质量标准、当批号的医疗器械检验报告单等。五、对首次经营企业和品种，采购员应填报首次经营企业审批表首次经营品种审批表，并将所附规定资料报采购部初审，报质管部对资质审核及财务部对价格审核报总经理审批。六、首次经营品种，质管部门要求建立产品档案。文档编码:

5、CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M

6、9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:

7、CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M

8、9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:

9、CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M

10、9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:

11、CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文档编码:CY6J4P2M2J8 HS4X6Y2M9H1 ZV2D2B9F5S9文件名称医疗器械购进管理制度起草部门质管部文件编码 HZqx.QM.002.01起草：年月日审核：年月日批准：年月日执行日期：年月日变更记录：变更原因及目的：医疗器械购进管理制度一、医疗器械的采购必须严格贯彻执行医疗器械监督管理条例、经济合同法、产品质量法等有关法律法规和政策，合法经营。二、采购人员须经培训合格上岗。三、采购业务：（一）采购医疗器械应选择具有法定资

12、格的供货单位。（二）进口医疗器械必须由国家药品监督管理局出具的医疗器械注册证、医疗器械产品注册登记表等复印件。以上批准文件应加盖有供方单位的原印章。（三）坚持“按需进货、择优采购”的原则，注重医疗器械采购的时效性和合理性，做到质量优、费用省、供应及时，结构合理。（四）签定医疗器械购销合同应明确以下质量条款：1、医疗器械的质量符合规定的质量标准和有关质量要求；2、附产品合格证；3、包装符合有关规定和货物运输要求；4、购入进口产品时，供应方应提供符合规定的证书和文件。（五）、首营企业和首营品种按本公司医疗器械首营企业和首营品种质量审核制度执行。（六）、购进医疗器械要有合法票据，购进医疗器械必须建立

13、完整的医疗器械购进记录。购进记录必须记载：购货日期、供货单位、购进数量、单价、品名、规格（型号）、生产厂商、质量情况、经办人等。医疗器械购进记录必须保存至超过有效期或保质期满后2 年。四、每年年底对供货单位的质量进行评估，并保留评估记录。文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3

14、HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8

15、ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档

16、编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R

17、3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L

18、8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3

19、文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文件名称医疗器械质量验收

20、制度起草部门质管部文件编码 HZqx.QM.003.01起草：年月日审核：年月日批准：年月日执行日期：年月日变更记录：变更原因及目的：医疗器械质量验收制度一、根据医疗器械监督管理条例等有关规定，为保证入库医疗器械质量完好，数量准确，特制定本制度。二、验收人员应经过培训，熟悉医疗器械法律及专业知识，考试合格上岗。三、医疗器械验收应根据医疗器械监督管理条例等有关法规的规定办理。对照商品和送货凭证，进行品名、规格、型号、生产厂家、批号（生产批号、灭菌批号）、有效期、产品注册证号、数量等的核对，对货单不符、质量异常、包装不牢固、标示模糊等问题，不得入库，并上报质管部门。四、进口医疗

21、器械验收应符合以下规定：（一）进口医疗器械验收，供货单位必须提供加盖供货单位的原印章医疗器械注册证、医疗器械产品注册登记表等的复印件。（二）1.核对进口医疗器械包装、标签、说明书，是否用使用中文,2.标明的产品名称、规格、型号是否与产品注册证书规定一致,3.说明书的适用范围是否符合注册证中规定的适用范围,4.产品商品名的标注是否符合医疗器械说明书、标签、包装标示管理规定,5.标签和包装标示是否符合国家、行业标准或注册产品标准的规定。五、验收首营品种应有首批到货同批号的医疗器械出厂质量检验合格报告单。六、外包装上应标明生产许可证号及产品注册证号；包装箱内没有合格证的医疗器械一律不得收货。七、对与

22、验收内容不相符的，验收员有权拒收，填写拒收通知单，对质量有疑问的填写质量复检通知单，报告质管部处理，质管部进行确认，必要的时候送相关的检测部门进行检测；确认为内在质量不合格的按照不合格医疗器械管理制度进行处理，为外在质量不合格的由质管部通知采购部门与供货单位联系退换货事宜。八、对销货退回的医疗器械，要逐批验收，合格后放入合格品区，并做好退回文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:C

23、X5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL

24、7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL

25、6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码

26、:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3

27、HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8

28、ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档

29、编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3验收记录。质量有疑问的应抽样送检。九、入库商品应先入待验区，待验品未经验收不得取消待验入库，更不得销售。十、入库时注意有效期，一般情况下有效期不足六个月的不得入库。十一、经检查不符合质量标准及有疑问的医疗器械，应单独存放，作好标记。并立即书面通知业务和质管部进行处理。未作出决定性处理意见之前，不得取消标记，更不得销售。十二、验收完毕，做好医疗器械入库验收记录。入库验收记录必须记载：验收日期、供货单位、验收数量、品名、规格（型号）、生产厂商、批号（生产批号、灭菌批号、有效期、注册号、质量情况、经办人等。医疗器械入库验收

30、记录必须保存至超过有效期或保质期满后2 年。文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL

31、6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码

32、:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3

33、HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8

34、ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档

35、编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R

36、3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文件名称医疗器械在库保管、养护制度起草部门质管部文件编码 HZqx.QM.004.01起草：年月日审核：年月日批准：年月日执行日期：年月日变更记录：变更原因及目的：医疗器械在库保管、养护制度一、要根据不同季节、气候变

37、化，做好库房的温湿度管理工作，坚持每日两次（上午 9:00-10:00，下午 2:00-3:00）按时观察库内温、湿度的变化，认真填写“温湿度记录表”，并根据具体情况和医疗器械的性质及时调节温湿度，保证医疗器械贮存质量。温度控制：常温库为1030，阴凉库为温度 20，冷库温度为210；湿度控制在 45-75%之间。二、养护人员应对在库医疗器械每季度至少养护检查一次，可以按照“三三四”循环养护检查，（所谓三三四指一个季度为库存循环的一个周期，第一个月循环库存的30%，第二个月循环库存的30%，第三个月循环库存的 40%）并做好养护记录，发现问题，应挂黄牌停止发货并及时填写“质量复检通知单”交质管

38、部门处理。四、养护员对近效期商品挂牌标示、按月填报医疗器械近效期催销报表表，督促业务部门及时催销，以防过期失效。六、做好货贺的清洁卫生，做好防火、防尘、防潮、防热、防霉、防虫、防鼠、防鸟、防污染等工作。七、医疗器械实行分类管理：（一）一次性使用无菌医疗器械单独存放；（二）一、二、三类医疗器械分开存放；（三）整零分开存放；（四）有效期器械分开存放；（五）精密器械分开存放。八、在库医疗器械均应实行色标管理。其统一标准是：待验区、退货区为黄色；合格品区、发货区为绿色；不合格品区为红色。文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3

39、HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8

40、ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档

41、编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R

42、3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L

43、8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3

44、文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R

45、8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文件名称医疗器械出库复核制度起草部门质管部文件编码 HZqx.QM.005.01起草：年月日审核：年月日批准：年月日执行日期：年月日变更记录：变更原因及目的：医疗器械出库复核制度一、医疗器械出库，必须有销售出库复核清单。仓库要认真审查销售出库复核清单，如有问题必须由销售人员重开方为有效。二、医疗器械出库，仓库要把好复核关，必须按出库凭证所列项目，逐项复核购

46、货单位品名、规格、型号、批号（生产批号、灭菌批号）、有效期、生产厂商、数量、销售日期、质量状况和复核人员等项目。做到数量准确，质量完好，包装牢固。三、医疗器械出库必须遵循先产先出、近期先出和按批号发货的原则。出库按发货凭证对实物进行外观质量检查和数量、项目的核对。如发现以下问题要停止发货，填写出库拒发单，报有关部门处理：（一）外包装出现破损、封口不牢、衬垫不实、封条严重损坏等现象。（二）包装标识模糊不清或脱落；（三）已超出有效期。四、出库后，如对帐时发现错发，应立即追回或补换、如无法立即解决的，应填写查询单联系，并留底立案，及时与有关部门联系，配合协作，认真处理。五、发货复核完毕，要做好医疗器

47、械出库复核记录。出库复核记录包括：销售日期、销往单位、品名、规格（型号）、数量、批号（生产批号、灭菌批号）、有效期至、生产厂商、质量情况、经手人等，记录要按照规定保存至超过有效期或保质期满后2 年。文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7

48、U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K

49、8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6

50、P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6P7U8U3文档编码:CX5K8C9R8R3 HL7T6P6M10L8 ZL6Q6

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