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招文职一名,工作简单要求熟悉电脑基本操作!

发布者: 遵从内心 | 发布时间: 2019-2-16 14:53| 查看数: 9296| 评论数: 91|帖子模式

最新评论

fa2lk 发表于 2019-11-14 10:48:36
原标题:质量管理体系存缺陷,苏州久久寿医疗器械有限公司被责令停产  11月7日,国家药坛经地位品监督管理局官网发布《国家药监局关于苏州久久寿医疗器械有限公司停产整改的通告(2019年第77号)》 。  通告称,近期,国家药品监督管理局组织对苏州久久寿医疗器械有限公司进行了飞行检查。检查发现该企业质量管理体系主要存在以下缺陷:  一、楞严经大意机构与人员方面  查看五财神咒语企业《管理者代表任命书》QSSC版次1/B,2017年5月2日企业任命胡某为管代,但该管代自2018年以来因病进行治疗无法正常履行相关职责,不符合《医疗器械生产质量管理规范》(以下简称《规范》)中管理者代表负责建立、无量寿经解析实施并保持质量管理体系,报告质量管理体系的运行情况救苦往生咒和改进需求,提高员工满足法规、规章和顾客要求意识的要求。  二、设计开发方面  企业JJS-A9000A产品注册型式检测报告编号:(2016)ZC类第10600号-EMC中所附产品内部照片同产地藏经简体字版品实物样机内部比对后发现,高压变压器尺寸及进出线发生了变化,未识别更改可能导致的产品电气安全风险;企业针对有关产品抽检不合格情况,对输出口孔径和高压输出线插头尺寸进行了产品设计更改,但未提供相应设计变更风险识别、管理记录,不符合《规范》中当选用梵唱六字大明咒原版的材料、零件或者产品功能的改变可能影响到医疗器械产品安全性、有效性时,应当评价因改动可能带来的风险,必要时采取措施将风险降低到可接受水平,同时应当符合相关法规的要求。  三、采购方面  企业提供的高压变压器“承认书”(DATE:2013-12-05念妙法莲华经好处)中载明变压器结构尺寸且不含电阻基板部件,而所采购变压器实物为其他尺寸且含有电阻基板部件,采购物品同规定要求不相一致,不符合《规范》中确保采购物品符合规定的要求,且不低于法律法规的相关规定和国家强制性标准的相关要求。  该企业生产质量管理体系存在严重缺念地藏经注意事项陷,不符合医疗器械生产质量管理规范相关规定。该企业已对上述其质量管理体系存在缺陷予以确认。  国家药品监督管理局责成江苏省药品监督管理局依法责令该企业立即停产整改,对涉及违反《医疗器械监督管理条例》及相关法律法规的,依法严肃处理;责成江苏省药品监督管理局责无量寿经消业令该企业评估产品安全风险,对有可能导致安全隐患的,按照《医疗器械召回管理办法》的规定召回相关产品。  该企业完成全部项目整改并经江苏省药品监督管理局复查合格后方可恢复生产。
fvahm 发表于 2019-11-14 15:51:18

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