Study On Quality Management System Optimization Of MJ Medical Device Company

Under the great changes and new situation that the world is experiencing today,as our country promotes the building of China’s strength in quality,China puts forward the requirements of improving the level of total quality management,encourages enterprises to establish the value of winning by quality,participates in the innovation of quality management concepts,methods and tools,and actively promotes the transformation of quality management system to a new type.The main consideration is to deepen the "three rights" which contains all employees,all factors and the whole process of the enterprise,increase the application of full data participation,and vigorously promote the acceleration of the development maturity of the overall quality management of the industry.The task of establishing and operating an effective and appropriate quality management system and continuously improving their total quality management level has never been more urgent and important.As a key category of national supervision products,medical devices are clearly proposed to improve the quality and safety level in the construction of national quality power,and the implementation of the "four strictest" requirements,that is,the strictest standards for restriction,the strictest supervision,the most severe punishment for warning,the most serious accountability for deterrence,and the implementation of the whole subject,the whole variety,the whole chain of supervision.Therefore,medical device manufacturers have a strong demand for the construction of a good total quality management system.MJ Medical Device Company is a small-sized private medical device manufacturing enterprise with similar miniature representative in China.Based on the theory of total quality management and combined with the research status of total quality management applied to enterprises in the medical device industry,this paper takes MJ Medical Device Company as the research object.According to the operation status of its products and quality management system.Find out the main quality management links of the system problems clearly,and targeted analysis.Then put forward the corresponding quality management system optimization scheme.The optimization proposed in this paper is mainly classified from the six elements of manufacturing industry,namely "Man,Machine,Material,Method,Measurement and Environment ",and then gives specific optimization measures based on the "5W1H" analysis method.Finally,according to the actual situation and industry characteristics of MJ Medical Device Company,several safeguard measures are given to optimize the implementation of the scheme.MJ Medical Device Company is the epitome of many small-sized medical device startups.The study on the optimization of its quality management system can be used as a reference case for other companies in the industry,as well as the general quality management level and improvement direction of similar companies in the region,which has certain practical significance.