Diseño de un sistema de gestión de aseguramiento metrológico en la Empresa Tecmol Farmacéutica bajo las Normas ISO 17025:2017, Resolución 3619 y USP

Abstract

The purpose of this work is to carry out the design of a metrological assurance management system under the ISO 17025: 2017, Resolution 3619 and USP standards in the company Tecmol Farmacéutica S.A.S., through the review and analysis of compliance with the technical requirements of the standards, evidencing the need to propose a metrological assurance plan to ensure that its processes or services meet quality standards and are commercially recognized as a reliable laboratory. In order to support the quality of the results issued in the analyses, it is necessary to have the correct management of the measurement processes and the metrological confirmation operations of the equipment and measurement instruments used to demonstrate compliance with the requirements of metrological assurance and analysis of the issued data. For this, an improvement proposal is made that seeks to ensure that the suitability of the equipment and measuring instruments for the intended use is demonstrated, controlled, maintained and documented. Thus, activities are contemplated to ensure and give reliability to the results according to the technical requirements of the standards.