Research Of B Medical Device Company Quality Mangement System

B company is a world famous eye health care company,professional research,development,production and sales of eye care products,ophthalmic drugs and ophthalmic surgical instruments products.Founding more than 100 years,the production and operation organizations throughout over the world,and entered in the China market in 1987.B company in Beijing has strict quality assurance system to provide the most reliable products and services to consumers.In the medical device industry,B company first passed the ISO9000&ISO 13485 international quality management system certification.The Company products and sales eye care productions on behalf of the world's advanced level,including transparent lens,color lenses,care products,achieve universal coverage of the production.The research object of this article is B company's quality management system.Through the analysis of the internal and external environment of B company and the requirements of ISO9000 and ISO13485 quality management system standard,according to the PDCA method,optimize the quality management system.With B company quality management system as a optimized model,transform the original quality system and standard creativity,combine the new standard of ISO9001,ISO13485 and GMP to study and improve the existing quality system.With the daily supervision,the quality management system will operate smoothly under the requirements of regulations.Furthermore,the efficiency will improve greatly.Through the close union of theory and practice,the research provides a replicable practices for medical devices domestic enterprise who reconstruct the new ISO13485 and ISO9001 quality management system with the Good Manufacturing Practice.The author drew some worthy conclusions for communication in this paper.