Diseño de un sistema de gestión en base a la orma NTE INEN-ISO/IEC 17025:2018 para el laboratorio de control de calidad en la empresa Holviplas S.A.

Abstract

Nowadays, laboratories must guarantee the reliability of their test results to ensure product quality. An effective way to achieve this is to implement a management system based on the NTE INEN-ISO/IEC 17025:2018 standard. The objective of this degree work was to design a management system aligned to this standard for the quality control laboratory of HOLVIPLAS S.A., which allowed managing the activities and assuring the tests. The project is based on applied, documentary and field research; it is applied because the processes necessary to standardize the activities were documented; documentary, because the bibliographic information was systematized for the diagnosis and development of the project; and field research, due to the direct collection of information by the researcher. The process began with the identification of the problem and the definition of the objectives, followed by the investigation of the normative and theoretical bases for the design of the system. In the initial analysis, the compliance self-assessment questionnaire provided by SAE, in accordance with NTE INEN-ISO/IEC 17025:2018, was used, along with general laboratory information, which provided a basis for the project proposal. Finally, a quality manual, process map, procedures manual, risk management matrix and process characterization were developed, comprising 9 processes and 30 procedures, which made it possible to comply with the requirements established in the standard.