All-sided Management And Implementation Of Quality Guarantee System Of Medical Appliance Manufacturers

Medical appliance manufactures are capable to provide adequate products with warranted quality for the customers from home and abroad, which is forced by quickly changed market environment, governmental restrictions on the production of medical apparatus and instruments as well as their quality or performance, and public opinion pressure from kinds of social organizations. International Standardazation of Organization proposed the ISO 13485 as the Quality Management Systems Medical Devices Package, which specifies the requirements and procedures to implement a quality management system for an organization that needs to consistently meet regulatory requirements applicable to medical devices and related services. The full implementation and management of ISO13485: 2003 is the most convenient and fastest channel to give the manufacturers a quality guarantee. The main researches of this thesis include how to introduce, establish, apply and manage fully ISO13485: 2003, and demonstrations its suitability, sufficiency and validity to improve the quality of the products made in these companies.This thesis analyzes the production and management situation of domestic and international medical appliance manufacturers, putting forward the problems confronting small and medium family firms in the area of quality management, Some of the quality management methods have been practiced over three years in the family type medecail appliance firm. The framework of quality assuring system for the enterprise has been constructed on the basis of classic project quality management theory and ISO quality guarantee system. The project management puts emphasis on the implementing stage so that the company's quality quarantee ability is approved by the domestic & abroad clients and superior regulatory department of government via vertical management from up to down, complete supervision from beginning to the end, all-staff administration integrated point and plane, and PDCA circular management. At last, Shanghai Food & Drug Administration ranked the above company as Grade A Quality Trustable Enterprise at the first time in 2008; the company obtained certain social and economic profits after implementation of this project.All-sided management and implementation of quality guarantee system of medical appliance manufacturers is also a complicated project management, which provides those kinds of companies applying ISO13485: 2003 some practical experiences, enriches the content of quality and assurance management in the project as well.