Diseño documental para el sistema de gestión de calidad en SIMA Inc SAS según estándar ISO 13485:2016

Abstract

SIMA, is a company with a 10-year track record in the commercialization of aesthetic implants; It is currently the leader in the national market and has a headquarters located in Bogotá and this year increased commercial agreements with multinational companies, highlighting their products in different parts of South America and Europe. A diagnosis was developed in the company in order to understand the current process management that is carried out and implement a strategic plan that allows the most efficient interaction of all the processes of SIMA, in order to reduce costs, improve delivery times and increase customer satisfaction. Also minimizing manufacturing reprocessing and controlling production times efficiently, which allowed to identify the causes for which reprocessing occurs, delays in delivery times and increase in complaints and claims by customers, based on that is structured a work plan with strategies, which allow to define a process of implementation of the ISO 13485 - 2016 quality management system. It seeks to reorganize the company to improve the activities in each of its processes.