Guía metodológica para buenas prácticas de manufactura basada en la NT ISO 13485 para empresas fabricantes de dispositivos médicos
Fecha
2020-12-16Registro en:
Cañaveral Rodríguez, A. F. & Ramos Ramos, J. (2020). Guía metodológica para buenas prácticas de manufactura basada en la nt iso 13485 para empresas fabricantes de dispositivos médicos. Tesis de Grado (Maestría en Calidad y Gestión Integral) Universidad Santo Tomas
reponame:Repositorio Institucional Universidad Santo Tomás
instname:Universidad Santo Tomás
Autor
Cañaveral Rodríguez, Alix Fernanda
Ramos Ramos, Javier
Institución
Resumen
This document is a study related to the development of a tool
self-diagnosis and a methodological guide applicable to organizations linked to
any stage of the life cycle of medical devices, they want to implement
successfully a quality management system based on ISO 13485: 2016.
For the development of this document, an extensive process of consultation and
research, after which it is planned, analyzed, designed and validated by experts each
one of the products of the document. These tools turn out to be functional since
that facilitate not only the implementation of the quality management system but also the
understanding of how organizations should operate in such a way that they obtain
all the benefits of operating under the structure of a management system. The objective
design is achieved and validation is successful although it is flexible documents that
must be modified in accordance with changes in regulatory requirements or in the
standard, which is guided by the principles of safety and efficacy, associated in this
case with patient safety and quality of care in the health sector.