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浙江食药监局:药品化妆品审评中心完成ISO9001质量管理体系的首次内审

2017-08-04 14:31:59   中国经济网

中国经济网北京8月4日讯 (记者 吴晓薇)记者从浙江食品药品监督管理局网站获悉,2016年底,浙江省药品化妆品审评中心通过了ISO 9001质量管理体系认证并获得了认证证书,为审核评价中心质量管理体系建立的符合性和运行有效性,保证体系持续改进,浙江省药化审评中心于7月31日至8月2日开展首次质量体系内审工作。

这次内审涵盖了药品化妆品技术审评、不良反应监测工作的全要素,包括业务工作本身、为完成业务工作所提供的保障工作和制度体系建设,一方面是检查中心各项工作是否按质量管理体系文件要求开展以确保运行的有效性,另一方面是检验管理体系是否结合工作实际以推动体系的持续改进。

通过工作台账的抽查、相关人员质询和工作流程跟踪等手段,内审结果表明中心各项工作体系的运行规范、有效,但也发现了文件控制有缺漏、原有制度程序不适应新情况和部分工作缺乏制度体系文件规范等问题,针对这些问题,内审组专门制定整改计划,落实到人,并明确时间,确保内审效果。

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