Abstract：In order to further clarify the working process of medical device standard revision and improve the quality of the work, this paper applies the concept of continuous improvement in quality management to the whole process of medical device standard revision, and corresponds the main links in the working process of medical device standard revision to the elements in ISO/IEC 17025. The establishment, drafting, verification, request for comment, inspection, approval and issuing, implementation and evaluation, review and abolishment of medical device standards can be corresponded to contract review, internal audit, results and records control, purchasing services and supplies, ensuring the effectiveness of results, corrective actions and management reviews in the quality management system. The process of standard revision is similar to the operation of the quality management system. The methods to ensure the effectiveness of the quality management system can be extended to the process of standard revision, so as to achieve continuous improvement and improve the quality of standards.
毛歆 韩倩倩 王春仁. 以质量管理的视角探讨医疗器械标准制修订工作流程[J]. 中国医药导报, 2021, 18(9): 68-72.
MAO Xin HAN Qianqian WANG Chunren. Discussing the working process of medical device standard revision from the perspective of quality management. 中国医药导报, 2021, 18(9): 68-72.
2021, Vol. 18 
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