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陕西省医疗器械质量监督检验院 >> 信息动态 >> 最新动态 >> 正文
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陕西省医疗器械质量监督检验院 >>最新动态 >> 正文
陕西省医疗器械质量监督检验院 开展2019年度质量管理体系内部审核工作
作者:未知 信息来源:本站原创 点击数:96 更新时间:2019/11/14 1:46:33

11月12日~13日,按照2019年度质量管理体系工作计划和内部审核计划的安排,我院进行了本年度质量管理体系内部审核。本次内目的是验证我院质量管理体系文件与标准的符合性、质量管理体系运行的有效性和持续性,内审的范围涉及质量管理体系覆盖的管理层、技术负责人、质量负责人和11职能科(室),涵盖机构人员场所环境设备设施、管理体系等全部质量活动。

各内审组依据相关法律法规、质量管理体系文件的要求,严格按照内审计划,采取现场核查、报告/证书抽查、查阅资料、口头提问等方式,对各科(室)质量管理体系运行情况进行了全面的检查,对文件资料进行了认真审核。开具4不符合项,并形成了不符合项清单,质量负责人代理人张成副院长就内审发现问题的整改措施提出要求。

通过现场审核,审核组一致认为,我院科(室)能够认真贯彻实施第版质量管理体系文件要求,各种质量记录真实可靠,见证资料较齐全,基本符合标准质量管理体系文件要求,能够保证质量管理体系的符合性、有效性和持续性。下一步,我院将把质量管理体系打造成保障工作质量的有力抓手,进一步促进和提高质量管理水平。

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