Diseño del sistema de gestión de acreditación para el laboratorio de ciencias de la ESPOCH sede Orellana bajo la norma NTE INEN-ISO/IEC 17025

Abstract

The present work focused on designing a quality management system under the Ecuadorian Technical Standard NTE Instituto Ecuatoriano de Normalización - Organización Internacional de Normalización/Comisión Electrotécnica Internacional (INEN-ISO/IEC 17025:2018) for the Science Laboratory of Espoch Sede Orellana. The methodology was divided into three sections; the first one contemplates a descriptive analysis through bibliographic research of the context of quality systems, as well as an investigation through interviews that allow having knowledge of the context of the laboratory; subsequently, an inventory of equipment was carried out with the objective of knowing the instruments that the laboratory owns, and finally the general procedures of the management system were designed. The content of the research was based on the design of the general procedures for equipment, reagents, and volumetric material, which allowed the development of a structure and documentary content, as well as the guidelines for the management and calibration processes of equipment, reagents and volumetric material. As a final result, the quality management system was designed considering the requirements of the Ecuadorian technical standard INEN-ISO/IEC 17025:2018. Therefore, it is concluded that ISO quality defines quality control as the part of the mandatory quality management requirements to comply with accreditation, thus, it is recommended to continue the documentation process based on the guidelines already established for document control.