Quality Management System Study For FM Company

With the enhancement of the science technology development and increasingly internationalization of market competition,people will have higher expectation on medical device quality.FM Company,which is a China medical device OEM Company,in order to manufacture high quality products to meet the China market’s requirement,needs urgently to set up quality management system and maintain it to be adequate,effective and suitable.This will enhance the competiveness of the company.The thesis was based on the research object of local medical device manufacturer FM.By means of analyzing FM quality management system defect including supplier management,corrective action and preventive action and process validation which were discovered by Large Foreign Medical Device Company(B Company)during the approved OEM supplier qualification;combining current status of FM quality management system;applying quality management system theory and project management tool;improving the key process procedures of FM;creating job description,process map,key process implementation template and improving measure.Finally,the improved key process applied in FM product and process quality management cases to verify the effectiveness of process improvement.Through key process improvement and implementation,FM enhanced quality management system level and successfully set up quality management system which could meet the requirements of China regulation and B Company.