Sistema de gestión de calidad en el laboratorio de ciencias básicas y especialización de la ESPOCH Sede Orellana en base a la NTE INEN-ISO/IEC 17025:2018

Abstract

The Laboratory of Basic Sciences and Specialization of ESPOCH Orellana Campus does not have a Quality Management System (QMS), therefore, the objective of the present work was to implement a QMS based on NTE-ISO/IEC 17025:2018. The methodology applied was Theoretical and technical: in order to carry out the theoretical research, the NTE INEN-ISO/IEC 17025:2018, which describes the general requirements relating to the technical competitiveness of testing and calibration laboratories, while the practical research consisted of the implementation of the QMS (writing of the quality manual, the general procedures, and the technical test instructions). In addition, a descriptive, analytical, and systematic approach was carried out to obtain and process the information. As a result, the following was elaborated General Document Preparation Procedure (PG-LABESPOCH-01) with four materials the Quality Manual with 23 duly codified chapters and 40 chapters with 40 formats for the proper management of the QMS information; the General Procedure for the Management of Documents (PG-LABESPOCH-02), with four corresponding materials, the General Procedure for the Archiving of Documents (PG-LABESPOCH-08); and 13 Instructions. Testing Technicians that improve the execution of laboratory practices. It is concluded that the QMS was properly implemented in accordance with the regulations, since, through an exhaustive diagnosis, the laboratory did not present the aforementioned documentation, this helps to obtain efficient and reliable results. It must be developed and concluded with the general procedures corresponding to “Uncertainty calculation”, “Validation of analytical methods” and “Internal Audits ¨ to complement the QMS in its entirety.