Guía metodológica para la implementación de un sistema de gestión de calidad, armonizando la Norma ISO 9001:2015, la resolución 2378 de 2008 del INVIMA y la Norma Europea ISO 14155:2011 para los centros de investigación clínica de Colombia

Abstract

The main objective of the degree project is the design of a Methodological Guide that integrates the strategic aspects of the ISO 9001:2015 Standard with the operational aspects of INVIMA Resolution 2378 of 2008 and the UNE EN 14155:2011 Standard. This guide seeks those institutions that conduct research with drugs or medical devices in humans implement a quality management system based on continuous improvement, identification and management of risks associated with the system and the conduct of research studies, as well as to provide the center with the strategic vision that allows it to grow and remain sustainable as an organization. For the development of the guide, a comparison of the criteria of each of the standards was carried out, identifying the common items that could be harmonized. The product of this comparison was a list of harmonized criteria that integrated the three standards. These criteria were converted into a checklist validated by experts that allowed evaluating the compliance of a pilot research center (MEDICITY S.A.S.) in the city of Bucaramanga against the unified criteria. From this evaluation, the Methodological Guide was born, which focuses on the weak points and the generation of benefits that will be reflected in the continuous improvement of the research processes in the organization..