基于过程方法建立符合ISO13485的质量管理体系

Using the Process Approach to Build a ISO 13485-Certified Quality Management System

ISO 13485-2016《医疗器械质量管理体系用于法规的要求》制定了详细的指南来指导医疗器械生产企业创建强大的质量管理体系,促进医疗器械的质量达到安全性、有效性的要求。医疗器械质量管理体系不仅仅是企业对自身的要求,也是法规监管要求医疗器械生产全过程控制,降低产品风险,保障医疗器械安全有效的重要手段。但目前国内很多中小医疗器械生产企业对质量管理体系及其作用的认识不够,也不清楚如何建立符合ISO13485的质量管理体系。文章讨论了基于过程方法,如何将ISO13485的法规要求与本企业的实际运作结合起来,建立企业自己的符合ISO13485的质量管理体系。

ISO 13485:2016 Medical devices—Quality management systems—Requirements for regulatory purposes has formulated detailed guidelines to guide medical device manufacturers to create a strong quality management system and promote the quality of medical devices to meet the requirements of safety and effectiveness.The medical device quality management system is not only an enterprise's requirement for itself,but also an important approach required by laws and regulations to control the whole process of medical device production,reduce product risks,and ensure the safety and effectiveness of medical devices.However,at present,many domestic small and medium-sized medical device manufacturers do not have enough understanding of the quality management system and its role,nor do they know how to establish a quality management system that conforms to ISO13485.This paper discusses how to combine the regulatory requirements of ISO13485 with the actual operation of the enterprise to establish its own quality management system in line with ISO13485 based on the process approach.