2022年XX公司质量管理制度执行情况检查考核表 .pdf

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1、XX 公司质量管理制度执行情况检查考核表检查人：检查日期：年月日制度名称考核内容得分存在问题改进措施实施人签名有 关 部门、组织和人员的质量责任1.明确本部门、岗位的质量责任2.对本部门、岗位的质量责任了解、熟悉，并认真执行。质量否决规定1.质量管理部在进货和销售等经营活动中行使质量否决权2.质量否决权是以医疗器械质量标准与质量责任为依据，实行医疗器械质量问题确认与处理的决定权质量管理考核与评估的规定1.各部门对质量管理制度的实施情况，每半年全面检查一次2.考核中发现的问题，应拟定改进措施，落实整改时限及责任人首营企业和首营品种审核规定1.质量管理部负责首营企业和首营品种的审核2.不得从未经首

2、营审核的企业购进医疗器械，不得购进未经首营审批的品种。3.采购部按规定填报首营企业、首营品种审批表，并提交合格的资料。4.审核首营企业时，应审核企业的资格和质量保证能力5.审核首营品种时，应审核该品种的合法性及质量情况6.首营企业、首营品种进公司主管领导的签字批准7.首营企业、首营品种资料由质量管理部存档、方便查找采购管理1.采购部应购进合法企业合法生产或经营的质量可靠的医疗器械，不得从个人购进医疗器械。2.对购进医疗器械，须审核其合法性和质量可靠性。3.采购部负责对与本公司进行业务联系的供货单位销售人员进行合法资格的验证，相关的证明文件交质量管理部存档。4.签订书面采购合同，质量条款明确。5

3、.购进医疗器械具有合法票据，按规定建立购进记录，做到票、帐、物相符。6.质量管理部通过验收组对进货质量进行监控，对不合格医疗器械、不符合购货合同规定质量条款的医疗器械应予拒收。质量验收管理1.验收人员应熟悉验收工作流程及标准。2.医疗器械验收在仓库的专用区内进行验货。3、包装外观有异常、破损现象，则对异常、破损的均应开箱检查。零装医疗器械逐一验收。4、验收时对医疗器械外观质量、医疗器械内外包装及规定的包装标识进行检查，符合相关规定方可验收入库。5、整件包装中，应有产品合格证。6、医疗器械验收后，应做完整、规范的验收记录。7、验收记录内容完整，不缺项，字迹清楚，结论明确，每笔验收均应有验收员签字

4、盖章，按照规定保存。8、不符合规定或质量有问题的医疗器械应拒收不得入库。仓储保管、养护和出库复核的管理1.医疗器械根据其贮藏温度要求，分别陈列于阴凉库、冷库、常温库。2.医疗器械的储存应实行色标管理。其统一标准是：合格区和发货区为绿色、不合格区为红色、待验区和退货区为黄色。3.医疗器械按生产批号的顺序分层堆垛，不得混批。4.医疗器械堆垛之间、医疗器械与墙、屋顶（房梁）、空调、地面间距符合规定。5.医疗器械堆垛应严格遵守医疗器械外包装图式标志的要求。6、医疗器械与非医疗器械分库存放。7.易串味的医疗器械分库存放，危险品放在专用危险品库内。8.每天 2 次记录温湿度，若有超标采取相应的处理措施。9

5、 养护员对库房医疗器械定期进行循环质量检查，并记录于在库养护、检查记录。10建立养护品种养护档案。11养护员发现医疗器械质量问题时，挂暂停发货牌，同时填写质量复检通知单，报质量管理部。12医疗器械出库必须经发货、复核二道手续方可发出，13按先产先出、先进先出、易变先出、近期先出和按批号发货的原则发货。14 出库复核记录内容完整、有复核员签名。销售和售后服务管1.医疗器械销售时认真审核购货单位的法定资格、经营范围和商业信誉，防止医疗器械流向非法企业和机构，以保证经营文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7

6、H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G

7、9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5

8、X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8

9、V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G

10、5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2

11、X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3

12、B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6理的合法性、安全性。2.严禁销售假医疗器械、劣医疗器械3.正确介绍医疗器械，并以国家医疗器械监督管理局所批准的医疗器械使用说明书上的内容为准，4.按规定做好销售记录，做到票、帐、货相符。5.对质量查询、投诉、抽查、销售过程中发现的质量问题查明原因后，分清责任，采取有效措施，并做好记录对顾客意见或问题跟踪了解，件件有交待，桩桩有答复。有 关 记录、凭证和档案的管理1.记录与凭证内容应真实，填写及

13、时2各种记录和凭证不得任意涂改，如确实需要更改时，采用划线修改，保持原字迹清晰可辨，并签名确认。3.各记录做到一致性，连贯性医疗器械追溯性规定1.购进的医疗器械应有合法票据，并按规定建立购进记录，做到票、账、货相符。购进记录按规定保存。2.验收结果按合格品库（区）、不合格品库（区）、发货库（区）、等待库（区）、等专用场所区域进行管理。3.做好质量跟踪记录，以保证能快速、准确地进行质量跟踪。质量信息管理1.质量管理部为质量信息管理部门2.质量信息管理内容明确，符合企业实际3.质量部门日常要做好质量查询情况记录、质量投诉情况记录、质量抽查情况记录。4.质量信息根据分级分类及时传递，反馈和使用5.重

14、要的质量信息及时上报总经理不合格品管理规定1.质量管理部负责对不合格商品进行最终确认。并查明原因，分清质量责任2.经质量管理部确认为不合格品的，必须查明原因，分清质量责任，及时处理并制订预防措施。3.不合格品处理、报损和销毁等记录真实、完整，妥善保管。4.质量部门对不合格品的处理过程实施监督。医疗器械不良事件监测和报1.不良反应报告实行零报告制度，可疑即报。2.质量管理部为企业医疗器械不良反应监测管理小组，负责收集、分析、整理、上报企业不良反应信息。文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT

15、9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码

16、:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10

17、 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4

18、ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档

19、编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R

20、10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N

21、4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6告规定3.对发现的医疗器械不良反应，填写可疑医疗器械不良事件报告及时上报至医疗器械不良反应检测中心。4.质量管理部根据确认的不良反应对经营品种做出调整医疗器械召回规定1.由质量管理部门负责协助生产企业履行召回义务。2.在完成召回后10 日内向药品监督管理部门提交总结报告。3.监管部门在责令医疗器械生产企业召回某医疗器械过程中，要求经营公司立即停止销售该医疗器械的，立即停止销售该医疗器械，协助医疗器械生产企业

22、履行召回义务。卫生和人员健康状况的管理1.库房货垛整齐无杂物、摆放整齐有序无污染源，空气流通、环境美观，明亮整洁，无乱堆乱放2.库房周围地面平坦整洁、无积水、无垃圾，有防鼠等设施；3库房内外、检测场地和办公地点均应定期打扫卫生，保持环境整洁。4.质量管理、验收、养护、保管等直接接触医疗器械岗位的工作人员进行一次健康检查，并建立健康档案。计量器具和重要仪器设备管理制度1.养护员负责各种仪器的使用和保管，建立各种仪器的使用台帐、使用、检定记录2.所有计量器具和重要仪器设备应经过检定取得合格证后方可使用。3.养护员掌握各种计量器具和重要仪器设备的操作规程质量方面的教育、培训及考核的规定等1每年对全体

23、员工进行质量方面的教育、培训及考核，内容包括医疗器械法律、法规、规章和专业技术知识、职业道德、管理制度、质量责任、工作程序等内容。2.新上岗的员工须进行上岗质量教育和培训，考核合格后方可上岗。3建立培训记录、培训档案1、评分：5 分（非常满意）、4分（基本满意）、3 分（合格）、2 分（不满意）、1 分（极差）2、考核时逐项检核，存在问题填写清楚。3、整改措施：具体注明如何进行整改4、实施负责人签名齐全。文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1

24、R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3

25、N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K

26、6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3

27、I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7

28、H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G

29、9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5

30、X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6XX公司 首营企业审核记录编号：企业名称单位地址法人邮政编码电话许可证号营业执照号质量管理体系认证证书付款方式税务登记号经营或生产范围销售员姓名销售员身份证法人委托书起、止日期销售员姓名销售员身份证法人委托书起、止日期销售员姓名销售员身份证法人委托书起、止日期业务部门意见签字：年月日质量管理负责人审核意见签字：年月日企业负责人签字：年月日文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10

31、 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4

32、ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档

33、编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R

34、10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N

35、4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6

36、文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I

37、1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6XX 公司质量保证协议书供货方（以下简称甲方）：购货方（以下简称乙方）：为了加强医疗器械质量管理，确保器械质量，保障双方的共同利益，维护消费者权益，甲、乙双方本着平等、合作的原则，签订以下质量保证协议：一、甲、乙双方必须是证照齐全的合法经营企业，即具有医疗器械经营企业许可证（如供货方是生产企业的应具有医疗器械生产企业许可证）、营业执照、医疗器械注册证等必须的证照。甲方必须提供器

38、械购销人员的法人委托书及委托时限、身份证复印件，以便乙方备案。二、供货方保证经营的器械产品质量符合注册产品标准。货品内、外包装及说明书必须符合国家有关规定。三、甲方向乙方所供货品在包装上必须符合医疗器械的质量要求，包装牢固，符合储运运输要求，而乙方的储运条件应符合医疗器械所要求的条件，货品交付后如因储运不当造成经济损失由乙方负责。四、乙方收到甲方发运的货品，应及时验收，如发现货品缺少、破损等情况应及时通知甲方处理。五、乙方在经营或使用甲方提供的医疗器械中若发生质量问题，应提供详细、确定的质量信息，并积极配合甲方做好调查取证工作和善后处理工作。六、上述各条款未尽事宜，由双方协商一致约定。七、本协

39、议经甲、乙双方确认盖章后生效。八、本协议一式两份，甲、乙双方各执一份。九、本协议有效期：年月日至年月日止。甲方（盖章）：乙方（盖章）：日期：XX公司 首营品种审核记录编号：产品名称规格型号生产企业商品性能、质量用途、使用效果文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V

40、7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5

41、G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X

42、5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B

43、8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4

44、G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF

45、2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6等情况产品注册证号质量标准出厂检验报告书

46、储存条件包装、标签、说明书物价批件申请原因签字：年月日业务部门意见签字：年月日质量管理负责人审核意见签字：年月日企业负责人审批意见签字：年月日XX 公司拒收通知单编号：产品名称数量规格型号生产企业产品注册证号文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT

47、9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码

48、:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10

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50、ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档编码:CF2X5X3I1R10 HW3B8V7H3N4 ZT9A4G5G9K6文档