摘要
建立医疗器械标准化工作档案有助于提高档案管理工作的整体质量和效率,并推进考核评估工作。文章从医疗器械标准化技术委员会标准化工作档案的管理现状出发,结合档案管理要求和标委会考核评估细则,提出标准化工作档案归纳分类和归档范围的建议,建立医疗器械标准化工作档案的归档指南,为标委会档案管理提供参考。
Establishment of medical device standardization archive helps improve the overall quality and efficiency of archive management and promote evaluation of medical device standard organizations(SDOs).This paper is based on the current status of medical device standardization archive management of SDOs and administrative requirement.It proposed suggestion on categorization and scope of standardization archive,along with guideline for medical device standardization archive,and provides reference for archive management of SDOs.
作者
毛歆
柯林楠
韩倩倩
MAO Xin;KE Lin-nan;HAN Qian-qian(National Institutes for Food and Drug Control,Beijing 102629)
出处
《中国医疗器械信息》
2023年第19期39-42,共4页
China Medical Device Information
关键词
医疗器械
标准化
档案
medical devices
standardization
archives
