Research On Optimizing The Quality Management System Of H Medical Device Company

Medical devices play an important role in the prevention and treatment of human diseases,and their quality and safety play a decisive role in people’s health.At present,people’s living standards are also continuously improving,putting forward high requirements for the quality and performance of various medical device products.Especially after China proposed the "2030 Healthy China" national strategy,China has become increasingly strict in the supervision of medical devices.Therefore,how to significantly improve the quality of medical devices is a major challenge and challenge that all medical device companies need to face.At the same time,the competition in the medical device industry is becoming increasingly fierce.The hot spot of competition has changed from quantity competition to quality competition,from product and service quality competition to management quality competition,and its quality management has also entered the stage of total quality management.In this context,how to improve the quality competitiveness,improve the maturity of the system and improve the comprehensive performance has become a key issue that medical device enterprises need to study.This paper takes H Medical device Company as an example,based on literature analysis,total quality management,statistical process control,ISO13485 quality management system and other methods,summarizes relevant domestic and foreign literature,discussed the research significance,background,current situation of this paper,and then analyzes related concepts and theories to lay a theoretical foundation for this study.Subsequently,the status quo and management effect of H company’s quality management system are analyzed.Furthermore,with the help of H company’s existing data and questionnaire survey results,the existing problems and causes of H Company’s quality management system are analyzed.Finally,based on the problems involved and the reasons,the author put forward the quality management system optimization scheme of H company.Through this study,the following conclusions can be drawn:Through the analysis of the status quo and management effect of the quality management system of H Company,it is found that the management effect of the current quality management system of H Company is average.The problems existing in the product quality management system of H Medical device company are embodied in the following aspects:raw material inspection does not meet specifications,product design and research level is not high,product qualification rate is not high,and the rights and responsibilities of the main body of the after-sales link are unclear.Through the analysis of the causes of the existing problems,it is found that the main reasons are the lack of awareness of procurement risk management,the formalization of design and research internal audit and quality management,the lack of awareness of quality management in production and manufacturing process,and the weak continuity of quality management system.The quality system optimization plan of H company includes: control of raw materials,improve design and development based on TQM,conduct ISO13485 certification control in the production process,and improve aftersales service and customer training in the after-sales link.