Integración de las Normas NTC ISO 14001:2015, NTC ISO 45001:2018 y NTC ISO13485:2016 y su Alineación a un Sistema de Gestión Integral Basado en la Gtc 180:2008, en el Sector de Comercialización para Dispositivos Médicos en Colombia

Abstract

This degree project aims to develop the Integration of the NTC ISO 14001: 2015 Environmental Management System, NTC ISO 45001: 2018 Occupational Health and Safety Management System and NTC ISO 13485: 2016 Quality Management Systems of Medical devices; and in turn, align with a Comprehensive Management System based on GTC 180: 2008 Colombian Technical Guide for Social Responsibility, in the Marketing Sector for Medical Devices in Colombia.

The project has been developed through descriptive and qualitative research, which has been based on bibliographic references that were mostly published between 2015 and 2019.

One of the main and most important references that allowed the objectives of this project to be achieved is the manual: The Integrated Use of Management System Standards (IUMSS), which guides how to integrate Management Systems under the guidelines of the ISO. The methodology described in said manual allowed proposing an Integrated Management System for the Medical Device Marketing Sector in Colombia.

Once the Integrated Management System was established, it was analyzed how the benefits of said integration turn out to be important factors that allow the alignment with an Integral Management System considering that the characteristics of the GTC 180: 2008, should be extensible to all the processes in Special to the strategic ones, since through them a bet is made on the organizational development that will allow sustainability from the economic, social and environmental edges.

By generating an Integrated Management System for the Medical Device Marketing Sector in Colombia, the unified management of the different systems and their requirements applicable to the processes determined by the organization will be allowed; increasing efficiency, operational performance, favoring organizational strategy and strengthening the value of human talent. Factors that will easily align with the structuring of the Integral Management System.

Thus, an Integral Management System based on Social Responsibility strengthens the strategy of the Sector Organizations, because their processes will be oriented to sustainability. From the economic sphere, tools will be provided that will contribute to the alignment of the demands of the global economy by making sound decisions, allowing them to compete and adapt to changes in the markets; Regarding the social and environmental sphere, its primary objective is to seek to improve the quality of life of all interested parties, as well as promoting the conservation of natural resources that may be affected by the economic activity of the Sector.

In accordance with the above, a validation tool was implemented based on the Régnier Abacus methodology, through which the impact of the Integration and the Integral Management System was evaluated qualitatively, taking into account the criteria of technical experts, concluding that What has been developed in the present project turns out to be favorable to be applied in the future in organizations that market Medical Devices in the Colombian context.