中国标准化Issue(8)：190-193,4.DOI:10.3969/j.issn.1002-5944.2025.08.033
8D问题解决方法在医疗器械行业的适用性研究
Research on the Applicability of 8D Problem Solving Method in the Medical Device Industry
摘要
Abstract
In order to obtain a standardized and effective product quality problem solving method that is applicable to the medical device industry,this article combines the characteristics of the medical device industry and relevant legal and regulatory requirements to study the applicability of the 8D problem solving method widely used in the international automotive industry to solve product quality problems in the medical device industry,improves the traditional 8D problem solving method,with a focus on change management,and obtains an 8D problem solving method suitable for the medical device industry.关键词
8D/医疗器械/标准化/问题解决方法/变更管理/质量管理Key words
8D/medical device/standardization/problem solving method/change management/quality management引用本文复制引用
李指超..8D问题解决方法在医疗器械行业的适用性研究[J].中国标准化,2025,(8):190-193,4.
