Research On Quality Management Evaluation Of H Company

Since the 21 st century,the medical equipment industry has flourished in China.Although some companies have exported their products to European countries,most medical enterprises can not get rid of the status of low core technology and insufficient management standards.It is not recognized by developed country regulations and can not enter international markets.In order to improve the status of enterprise management and integrate into the international market,this paper explores the new path of quality management improvement through the research of H company.Based on the current research situation,documents,ISO 13485 standards and laws regulations,this paper evaluates the quality management of H company.It mainly contains the following research contents:First of all,the structure of the ISO 13485 standard and the meaning of the ISO 13485 standard are analyzed.And according to the standard,how does the medical device organization establish the quality management system.At the same time,this paper introduces the "Good Manufacturing Practice for Medical Devices" and explains its relationship with the ISO 13485 standard.Secondly,introduces the domestic medical device enterprise quality system operation status.This paper expounds the current situation of quality management in H company,analyzes the existing problems and the reasons for the problems.Then,based on the ISO 13485 standard and the requirements of the "Good Manufacturing Practice for Medical Devices",the quality management evaluation index system of H company is established.The indicator system is divided into four factors: "management responsibility","resource management","product realization","measurement,analysis,and improvement",and its next 20 indicator layers.Then explain how to use the Analytic Hierarchy Process,Fuzzy Comprehensive Evaluation Method to analyze the indicators.Finally,the index weight is determined by the evaluation factor index score of relevant experts.Using Analytic Hierarchy Process to calculate weights,and through Fuzzy Comprehensive Evaluation Method,the evaluation set is determined,the comprehensive evaluation results are analyzed and the quality management improvement strategies and measures are proposed to the enterprise.