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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.
(Universidad Técnica de Ambato. Facultad de Ingeniería en Sistemas, Electrónica e Industrial. Carrera de Ingeniería Industrial, 2025-02)
Tamayo Mejia Kevin Alejandro
;
Ureña Aguirre Jeanette del Pilar
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.
Diseño de un sistema de gestión, basado en la norma ISO/IEC 17025:2017, para la simulación del anclaje de asientos de autobuses en la empresa Cendingenieria S.A.
(Universidad Técnica de Ambato. Facultad de Ingeniería en Sistemas, Electrónica e Industrial. Carrera de Ingeniería Industrial, 2025-02)
Vargas Brito Anahi Elizabeth
;
Tigre Ortega Franklin Geovanny
Currently, the implementation of management systems based on international standards has become a fundamental strategy to guarantee the quality and reliability of laboratory results. This study aims to design a management system based on ISO/IEC 17025:2017 for the simulation of bus seat anchorages conducted by Cendingeniería S.A., in alignment with UN Regulation No. 80. The design process was grounded in a documentary research methodology, involving the review of bibliographic sources on quality management, international regulations, and methodological guides. An initial diagnostic assessment was conducted using a self-assessment questionnaire that evaluated the 141 requirements outlined in ISO/IEC 17025:2017. These requirements span general requirements, structural elements, resource management, process operations, and quality management systems. The findings revealed that 16% of the requirements are addressed through informal actions without proper documentation, 61% lack defined procedures or implemented actions, and 23% are not applicable to the laboratory. These results highlighted critical improvement areas, serving as a foundation for the system's design. The proposed management system incorporates nine essential components: Quality Manual, Process Map, Master List of Documents, Procedures Manual, Risk Management Matrix, Process Characterization, Forms, Reports, and Instructions. These elements ensure that laboratory activities comply with the standards specified in ISO/IEC 17025:2017. Furthermore, a risk matrix was developed, identifying 31 risks associated with laboratory procedures. For each identified risk, corrective actions, responsible parties, and execution timelines were defined to safeguard the continuity and reliability of the simulations.
Diseño de un sistema de gestión basado en la norma ISO/IEC 17025:2017 para el laboratorio de higiene industrial y ambiente de los talleres tecnológicos en la FISEI de la UTA
(Universidad Técnica de Ambato. Facultad de Ingeniería en Sistemas, Electrónica e Industrial. Carrera de Ingeniería Industrial en Procesos de Automatización, 2022-09)
Vargas Palango, Juan Pablo
;
Lema Chicaiza, Freddy Roberto
Nowadays, companies need to ensure that the test results are reliable, to achieve this they turn to accredited laboratories that have a Management System based on the ISO IEC 17025:2017 standard. The present degree work was developed in order to design a Management System based on the international standard ISO IEC 17025:2017 for the Industrial Hygiene and Environment Laboratory belonging to the Innovation and Technological Development Workshop of FISEI. This made it possible to manage factors involved in testing services and to indicate that it is operated competently. The project uses applied, documentary and field research. Applied, because the procedures were documented to standardize the activities. Documentary, because the bibliographic information was systematized for the diagnosis and development. Field, since the researcher collected the information directly. It began with the identification of the problem and the objective to be achieved, then the normative and theoretical bases for the design of the system were investigated. The initial analysis used the compliance self-assessment questionnaire provided by SAE, according to ISO IEC 17025:2017. This, accompanied by the general information of the laboratory, served as a starting point for the project proposal. Subsequently, the quality manual, process map, procedures manual, risk management matrix and process characterization, comprising 11 processes and 29 procedures, were proposed. These allowed us to address the requirements of the mentioned standard.

Ingeniería en Sistemas, Electrónica e Industrial

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