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1、文件名称医疗器械产品退货管理制度文件编号LDMD-ZD-015 起草部门质量管理部起草时间审核人审核日期批准人批准日期版本第 1 版执行日期医疗器械产品退货管理制度一、目的:为加强医疗器械产品退货的管理,对医疗器械产品退货的有效控制。二、范围:适用于本公司购进退出和销后退回医疗器械产品的管理。三、职责:质管部、采购、仓储部、财务部、销售部对本制度的实施负责。四、内容:1.定义:1.1 医疗器械退货产品系指销后退回和购进退出的产品。1.2 销后退回的医疗器械产品是指上级食品产品监督管理部门发文通知回收的产品和客户要求退货的产品。1.3 购进退出的产品是指非质量原因的在库产品退货和拒收产品退货。2
2、.销后退回产品的管理:2.1 销后退回的产品必须是本公司所售出的产品,并与原销售出库产品批号相符。2.2 销后退回的产品,由仓储部收货后,存放于有黄色标志的退货区,专人负责保管,并做好记录。2.3 产品质量验收人员应对销后退回的产品按购进产品质量验收的要求进行逐批验收,并做好验收记录,记录保存至超过产品有效期一年,但不得少于三年。2.4 销后退回的产品经验收合格的,由保管人员移入合格品区;不合格的,经质管部确认后移入不合格品区,并做好记录。2.5 销后退回的产品验收时质量状况判断不明的,应通知质管部进行复查,必要时,送法定产品检验机构进行检验。2.6 已办理销后退回手续的不合格产品,按不合格医
3、疗器械产品管理制度处理。3.购进退出产品的管理:3.1 非质量问题的购进拒收产品(超合同、无合同或不符合公司有关规定的),分别按以下程序办理:3.1.1 不符合公司有关规定的,由质管部通知采购员办理退货手续。3.1.2 属超合同、无合同的,由采购员与产品供货方联系后,办理相关手续。3.2 非质量问题的在库产品购进退出(批号调剂、产品滞销等),由购进部与产品供货方联系协商后,办理退货手续。4.相关记录、凭证齐全,妥善保存至超过产品有效期后一年,但不得少于3年。五、相关记录编号 1 医疗器械不合格产品退货记录LDMD-FM-16 文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5
4、W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY
5、5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 Z
6、Y5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10
7、ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10
8、 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U1
9、0 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U
10、10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10文档编码:CB7R4Q5W10P2 HE1V8N5T6U10 ZY5W5U2V5T10医疗器械不合格产品退货记录LDMD-FM-16退货日期退货单位产品名称规格型号产品批号数量不合格原因处理情况验收员质量管理人员文档编码:CM
11、7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:C
12、M7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:
13、CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码
14、:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编
15、码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档
16、编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文
17、档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5
18、文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y
19、5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10
20、Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y1
21、0Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y
22、10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9
23、Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5文档编码:CM7Q8C10H7V9 HS7L10P8M7W5 ZC7G6K9Y10Y5
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