Research On The Improvement Of ISO13485 Quality Management System In C Company

The International Organization for Standardization(ISO)released ISO 13485:2003 Medical devices-Quality management system-Requirements for regulatory purposes in 2003 and updated the standard in 2016 because the requirements for quality management between medical devices and general industrial products are different.This standard is significant to standardize medical device manufacturing enterprises,implement medical device laws and regulations,ensure the safety and effectiveness of medical devices,and improve the management level of enterprises.C company,founded in 2016,is a medical device enterprise that produces liquid chromatograph/mass spectrometer and kits.The quality management system established in accordance with the ISO 13485 standard has been operating in C company for nearly two years.Various quality problems often occur during the operation of the system.By improving the ISO 13485 quality management system of C company,this paper aims to improve the management level of C company,standardize the internal work flow,ensure the effective operation of the quality management system,and improve product quality and customer satisfaction.The main research processes are as follows:1?According to the basic principles and operation methods of quality management and combining with the results of two internal audits,The problems were mainly identified in four aspects:quality awareness,workflow,supplier management and production site management.And these problems were diagnosed and analyzed.2.In order to solve these problems,find out the root cause for the above problems,the general idea and plan are put forward to improve the quality management system.As a quality management tool,the "PDCA cycle" is used to implement the improvement solution.3.From three aspects of employee quality awareness,work flow,supervision and management mechanism(supplier management and production site management),this paper expounds the improvement effect of the quality management system of C company,and look forward to the continuous improvement of the quality management system of C company.At the same time,the research process of this paper has some reference value for those medical device enterprises that will establish and maintain the ISO 13485 quality management system.