近三年苏州工业园区医疗器械生产企业现场检查简析

      Finding Analysis of Medical Device Manufacturer Audit in Suzhou Industrial Park for the Last Three Years

      • 摘要: 目的 通过对2017年1月至2019年6月苏州工业园区进行的144家次医疗器械生产企业现场检查中不符合项进行汇总分析,找出不同类型的医疗器械生产企业在实施医疗器械生产质量管理规范现场检查中常见的不符合项,为医疗器械生产企业持续改进提供建议。方法 对不同类型的医疗器械生产企业在现场检查中发现的不符合项进行分类统计分析。结果 生产管理、厂房与设施、质量控制章节出现不符合的频率较高。结论 实现质量管理体系的提升,关键在于企业培养和建立员工对质量管理体系持续改进的意识,提升员工发现和解决问题的能力,增加全体员工在质量体系中参与度,使质量体系与产品实现贴合更紧密。

         

        Abstract: Objective Common findings are to be found from 144 different type of medical device manufacturers' audit reports which are from Jan. 2017 to Jun. 2019. Advise is to be provided for medical device manufacturers on continual improvement. Methods Classify and analyze the on-site audit findings from different type of medical device manufacturers. Results The frequency of findings from chapter production management, buildings and facilities, quality control are comparatively high. Conclusion The key to improve the quality management system is to cultivate the staff sense of continual improvement of quality system, improve the staff ability of finding and solving problems, encourage staff participation in quality system, fit the quality system on product realization.

         

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