8D問題解決方法在醫(yī)療器械行業(yè)的適用性研究

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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常用質(zhì)量問題解決方法簡介

近年來我國醫(yī)療器械行業(yè)高速發(fā)展，產(chǎn)業(yè)規(guī)模急劇擴(kuò)大，生產(chǎn)企業(yè)數(shù)量快速增長，但我國醫(yī)療器械行業(yè)還處在發(fā)展的初級階段，關(guān)于產(chǎn)品質(zhì)量問題的解決方法尚未形成行業(yè)通用的成熟方法論。（剩余4548字）