Research On The Optimization Of The Quality Management System Of Medical Device Companies

Medical device products are widely used in the prevention,diagnosis,treatment and monitoring of diseases.Its basic requirement is safety and effeciency.With the development of science and technology and people's pursuit of quality of life,the supervision and management requirements of medical devices are becoming stricter and stricter.In 2014,the State Council promulgated the "Regulations on the Supervision and Administration of Medical Devices".The State Administration of Food and Drug Administration(now the State Administration of Market Supervision and Administration of the People's Republic of China)responded positively to the call of the State Council,by promulgating the"Regulations on the Supervision and Administration of Medical Device Production" and the "Management standard on the Quality Control of Medical Device Production",and other relevant laws and regulations and documents,which put forward suggestions for the medical device higher regulatory requirements.After the international medical device standard ISO 13485:2016 was issued,our country first converted it into the medical device industry standard YY/T 0287:2017 for medical device quality management system for the requirements of laws and regulations,and required medical device enterprises to enforce it.At present,the core problem faced by all medical device companies is how to transform standard documents into system documents in line with the actual situation of the company,and how to ensure that the established quality management system can operate effectively and efficiently within the enterprise and maintain the consistency between the documents and the actual situation.In view of the above problems,taking the quality management system of F company as an example,this paper introduces the development history of F company's quality management system,system documents and problems arising from previous audits.According to the problems of previous audits and the contents of ISO 13485 standard,the questionnaire is designed and data are collected.In addition,from the four aspects of management responsibility,resource management,product realization,measurement analysis and improvement in ISO 13485 quality management system standard,the operation status of F company's quality management system is introduced in detail.According to the results of the questionnaire and the operation status of the quality management system of F company,some people were randomly selected for interviews to obtain interview data.By using the method of descriptive statistical analysis and based on the material and data obtained above,it is concluded that there are four main problems in the operation process of the quality management system of F company:personnel quality consciousness and ability,quality management document system,product design and development,and procurement management.This paper also analyses the causes of these four problems in the operation process of the quality management system of F company.According to the causes of these problems in combination with the actual situation of F company,we apply the process method in ISO 13485 standard and PDCA cycle method,and put forward specific optimization measures from the aspects of organization's training,strengthen communication,improve the operation supervision mechanism of quality system and strengthen continuous improvement,in order to further improve the quality management system of F company,promote the operation of the quality management system of F company more effective.Quality is the life of an enterprise.The establishment and effective operation of a quality management system in accordance with ISO 13485 standard in medical equipment enterprises can improve the quality of products,adapt the demand of the market,continuously and steadily produce products that meet the requirements of laws,regulations and standards and satisfy customers,and increase the trust of customers.Continuous quality improvement can improve the core competitiveness of enterprises and take more social responsibilities while satisfying profits.The analysis and research process of this paper has a good reference and guiding significance for similar medical device companies to improve the quality management system.