8D问题解决方法在医疗器械行业的适用性研究

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Research on the Applicability of 8D Problem Solving Method in the Medical Device Industry

LI Zhi-chao （Hunan Drug Inspection Center）

Abstract： In orderto obtain a standardized and effectiveproduct quality problemsolving methodthat is applicable to the medicaldevice industrythisarticlecombines thecharacteristics of the medicaldevice industryandrelevant legal andregulatory requirements to study the applicability of the 8D problem solving method widely used in the internationalautomotive industry to solve productquality problems in the medicaldevice industry，improves the traditional 8D problem solving method， witha focus on change management， and obtains an 8D problem solving method suitable for the medical device industry.

Keywords：8D， medical device，standardization， problem solving method，change management， quality management

0 引言

1常用质量问题解决方法简介

近年来我国医疗器械行业高速发展，产业规模急剧扩大，生产企业数量快速增长，但我国医疗器械行业还处在发展的初级阶段，关于产品质量问题的解决方法尚未形成行业通用的成熟方法论。（剩余4548字）