Quality management of medical devices. ISO 13485 Implementation Guide

Abstract

This research was aimed at creating a methodological guide for the implementation of the quality management system based on the NT ISO 13485: 2016 for medical devices manufacturers, which seeks to share with its readers the parameters necessary for implementing regulatory purposes and convey a perspective on how organizations should apply the standard requirements. The research considered the needs and expectations of organizations in Colombia producing medical devices, evaluated their ability to provide products and services that meet requirements and promote customer satisfaction through continuous improvement. The research starts from a theoretical base that analyzes the application of ISO 13485: 2016 and the requirement of good manufacturing practices in different countries, and the competitive advantages present by exploring the existing literature and the standard requirements. This article results have a mixed approach: quantitative, through the development of a self-diagnosis tool; and qualitative, through a methodological guide development. In each section of the standard, an exposition structure was adopted to facilitate content consultation and compression, thus fulfilling the purpose and applicability aiming to guide a clear and simple implementation.