Diseño de un manual de calidad para la empresa ASIA SOLUTION S.A.S basado en la resolución 4002 de 2007 del INVIMA

Abstract

ASIA SOLUTION SAS is a company whose main activity is the import and commercialization of biomedical equipment mainly for aesthetic use, initially founded in the city of Bogotá in 2014. It is currently operating in the city of Cali, through an initial diagnosis it is possible to identify absence of information due to poor organization, undocumented procedures which has generated reports of non-compliance, return of products for guarantee due to bad storage, lack of knowledge, lack of traceability of processes, which has generated loss of credibility in customers Due to the fact that the company does not have a certified quality management system, this is how document design takes importance through engineering methodologies that allow the identification of its organizational processes, the standardization of activities, the implementation of management indicators and clear objectives with r concrete results that reduce the difficulty to implement a QMS based on Resolution 4002 of 2007 of INVIMA, which allows to mitigate not only the absence of informality in the organization but also in order to achieve certification of storage and conditioning capacity of the CCAA medical devices, minimum requirement for all importing and commercializing establishments of medical devices.