The Improve Study Of The ISO13485 Quality Management System Of S Biological Company

With the development of science and technology, medical equipment products have been widely used in disease diagnosis,prevention,treatment and care.Their basic quality requirement for security and effectiveness has arouse social and people’s high attention. In order to improve the quality control of medical equipment. SFDA follows the same principle, changes the ISO13485:2003 into YY/T:2003 Medical devices- Quality management systems- Requirements for regulatory purposes.And related companies are required to follow.Since the Chinese Medical Device Quality Management Regulations has been implemented on June 1, 2014 and Regulation on the supervision and Management of Medical Device was effective on December 29, 2014,SFDA requires all the three types of medical device manufacturing enterprise shall follow the request of Regulation on the supervision and Management of Medical Device since January 1, 2016. All medical device manufacturing enterprise should follow too since January 1, 2018. To those enterprises who can not meet requirement in the required time, will be request to rectify and improve,or been penalized,stop production or even been revoked the medical device registration certificate, medical equipment production license, medical equipment business licenses. The revised laws and regulations push the promotion of the medical equipment quality control and at the same time give the medical device companies big opportunity but huge challenge.An enterprise can go ahead or close depends on weather they can rebuild the standard ISOI3485 quality management system on time.How to form a quality management system and how to make sure it can be carried on effectively and how to simplify the heavy and complicated work for the system have became the main focus for all the survivaled enterprises. To solve above problem, it is meaningful to build a prioritization scheme for quality management system of S Biological Company, to build innovative design methods for the system document and procedure sheet,to simply the record method and generated a system record. together with daily supervision and maintenance. Which will make S Biological Company proceed more smoothly under the requirement of quality management system and will reduce the running time cost at the same time. The created method of this paper will has realistic meaning for medical equipment quality management system.It offers practicable methods and reference regarding how to build ISO13485 quality management system under Regulation on the supervision and Management of Medical Device.