Study On The Optimization Of Quality Management System Of AB Medical Device Company

At this stage,domestic residents have generated a strong demand for medical services,which undoubtedly plays a role in promoting the rapid development of medical equipment market in China.The current medical device enterprises mainly produce materials and appliances that come into contact with the human body,which are indispensable for the development of medical care in China,and play an important role in treating disease links to better meet the disease links and prevent disease links.Most countries’ regulatory bodies require the quality management system of medical enterprises to be regulated.2011 onwards the implementation of the "Medical Device Production Quality Management Code(Trial)" and the "Medical Device Supervision and Management Regulations(Draft Revision)" implemented in mid-2014,indicate that domestic regulation in medical devices covers all aspects of registration,innovation,evaluation and approval,manufacturing,marketing,etc.Medical device GMP has now entered the general implementation stage,which not only helps medical device quality management system continue to improve,but also creates new problems and brand new opportunities for medical device manufacturing enterprises,in which the whole industry,especially small and medium-sized manufacturing enterprises,need to pay attention to the establishment and implementation of quality management system.The establishment and implementation of quality management systems can effectively help enterprises improve their management capabilities,standardize internal work processes,and provide assurance for the provision of stable and qualified product quality.However,in the exploration of quality management systems in the medical device industry,it was found that the quality management systems of small and medium-sized medical device companies are imperfect,and the optimization studies for potential problems in the implementation stage are insufficient.Therefore,this study integrates the characteristics of the medical device industry and examines the quality management system of AB Medical Devices,which is mainly engaged in the technological development,manufacturing and marketing of medical devices.Compared with the global top 500 companies,there are still many problems in the management of their quality system.Therefore,this thesis takes AB Medical Devices as a case study,and uses literature research method,questionnaire method,and PDCA cycle method to study its quality management system.Firstly,the questionnaire method was used to analyze its four problems: unclear management responsibilities,inadequate human resource training,imperfect product realization system,and slow continuous improvement,etc.The deep-seated reasons for these problems are the company’s lack of awareness of the quality management system,weak quality awareness of all employees,no good supplier quality management mechanism,and whole process quality management.Secondly,based on the design of the general idea of optimization,the optimization plan of quality management system of AB medical device company is proposed,which mainly includes: optimization of management responsibility system,optimization of human resource management system,improvement and optimization of product realization system,optimization of continuous quality improvement system,and optimization of quality control and feedback system.Finally,the guarantee measures for optimization are proposed from four perspectives,such as implementing quality management responsibilities,establishing project responsibility system,implementing new product development removal system,and improving quality system operation and supervision mechanism.The research results obtained in this paper can help AB Medical Devices further optimize and improve its quality management system,and the implementation of the designed optimization plan can help the company improve quality and efficiency,optimize product quality,enhance the company’s competitive level,and achieve the goal of long-term positive development,as well as provide reference for other similar enterprises in China to optimize their quality management system.