| Recently,with the significant advance of the financial market and the progress of science and technology,the market development spectrum of medical device has been expanding,the quality and technical level of medical equipment products have also been improving,and the types and models of medical equipment have become more and more complete.However,while the market scale is growing rapidly,the medical device industry also exposes some quality management problems that need to be solved urgently.This thesis takes Y medical device company as our object,conducts research and narration according to the progressive logic,asks questions in turn,analyzes the causes of the problems,and finally solves the problems.This paper mainly uses PDCA cycle mechanism and total quality management theory to find out the problems of the company’s quality management system in the implementation of the system,the continuous improvement of the system and the enthusiasm of employees through questionnaires and interviews,and analyzes the causes of the problems in depth.Moreover,the quality management system of Y Medical Device Company is optimized in terms of content,internal audit,management review,quality information system,and incentive mechanism.Finally,five safeguards are put forward,including implementing the quality commitment of managers,creating a quality culture learning atmosphere,improving the company’s quality management system,strengthening the content of quality management training and improving the human resources system.The research results of this thesis can not only make the quality management system of Y medical device company more suitable for the factual situation of the company,but also make the system fully play a role,so as to help the company to achieve the quality goal,and further improve the efficiency and effect of the system running.The result is helpful for Y medical device company to form high-quality products,and it also provides advice and reference for other small and medium-sized medical device companies to further optimize the system. |