Improvement Of Quality Management System For XK Medical Device Company

Since the implementation of "Medical device production quality management specification(trial)" and "Medical device supervision and management regulation",the supervision of medical device in China has achieved all-round coverage from registration,review,production and operation,and the production quality management specification of medical device has gradually entered the stage of comprehensive implementation.Therefore,medical device manufacturing enterprises are faced with both rare opportunities and severe challenges,especially small and medium enterprises are faced with the pressure and impetus of reintegration and development.As a small and medium-sized private medical device manufacturing enterprise,XK Medical Device Company must improve itself from product quality management in the face of higher and more comprehensive requirements of medical device quality management system,and the optimization of the company’s quality management system is imperative.This thesis briefly expounds the basic principles of total quality management,plan-do-check-action cycle and medical device quality management system.Then,it analyses the current status of XK Medical Device Company’s quality management based on relevant requirements of medical device regulations,it also summarizes the main problems in the operation of the company’s quality management system,including weak quality management in the process of product design,development and transformation,lack of supplier quality management,internal audit of the quality management system,etc.,and analyses the causes of the problems.On this basis,the thesis puts forward the optimization goal of XK Medical Device Company’s quality management system,and mainly discusses the optimization plan of the company’s quality management system from the aspects of quality control in the design and development process,supplier audit and raw material quality control,quality management system internal audit quality control and so on.Finally,this thesis elaborates the implementation steps and safeguard measures of XK Medical Device Company’s quality management system optimal scheme,and further analyses the optimization effect of the company’s quality management system.It isexpected that the research conclusions of this thesis can provide reference for XK Medical Equipment Company as well as other small and medium enterprises in the same industry to improve their quality management level.