Evaluación del estándar ISO 15189:2012 en cinco laboratorios clínicos de la red de salud pública del pacífico colombiano

Mercedes Salcedo Cifuentes; Lina Mayerly Cruz Parra; Carolina Quiroz Arias; Miryam Escobar

doi:10.22490/

Evaluation of the ISO 15189:2012 standard in five clinical laboratories of the public health network of the colombian Pacific

Evaluación del estándar ISO 15189:2012 en cinco laboratorios clínicos de la red de salud pública del pacífico colombiano

Published 2025-07-01

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Vol. 23 No. 44 (2025): 2025-01

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Salcedo Cifuentes, M., Cruz Parra, L. M., Quiroz Arias, C., & Escobar, M. (2025). Evaluation of the ISO 15189:2012 standard in five clinical laboratories of the public health network of the colombian Pacific. Revista Nova, 23(44). https://doi.org/10.22490/

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https://doi.org/10.22490/

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Mercedes Salcedo Cifuentes

University of Valle

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https://orcid.org/0000-0002-9681-6893

Lina Mayerly Cruz Parra

Instituto Tecnológico Metropolitano

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https://orcid.org/0000-0001-5348-9792

Carolina Quiroz-Arias

University of Valle

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https://orcid.org/0000-0003-2148-7383

Miryam Escobar

University of Valle

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https://orcid.org/0000-0003-2459-8660

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Mercedes Salcedo Cifuentes,

Bacteriologist and clinical laboratory technician graduated from the Universidad del Valle.

Specialization in Total Quality and Productivity Administration, Master's Degree in Epidemiology and Doctorate in Biomedical Sciences from the Universidad del Valle.

National Prize for Genetics and Biotechnology 2014 from the Colombian Association of Biological Sciences.

Recognition for the contribution to the field of forensic technical and scientific research in the country awarded in 2014 by the National Institute of Legal Medicine and Forensic Sciences.

Researcher in the CALIMET and CEDETES research groups of the Faculty of Health of the Universidad del Valle.

Director for 3 years of the Center for the Development and Evaluation of Policies and Technology in Public Health, CEDETES. WHO/PAHO Collaborating Center.

With internships in mass, volume and temperature metrology at the metrological center of the Faculty of Chemistry of the Universidad Autónoma de Mexico and the Universidad Politécnica de Santa Rosa Jáuregui (UPSRJ).

Diploma in metrology from the Mixed Metroquality Corporation of the Universidad del Valle.

Senior researcher at Minciencias.

Peer evaluator of the National Accreditation Committee of the Ministry of Education.

Peer evaluator of Minciencias.

He has worked for more than 10 years in the area of quality for laboratories, initially in the forensic field and later in health.

With several directions of postgraduate work and research projects in quality and metrology, standardization of processes, evaluation of compliance with protocols, human factors that mediate the implementation processes and implementation of quality, among others.

More than 20 years in teaching and research at the Universidad del Valle.

Quality coordinator of the Faculty of Health of the Universidad del Valle and member of the central quality committee of the Universidad del Valle for 8 years.

Manager and coordinator of the Interfaculty Master's Degree in Quality Management for Laboratories.

Teacher and researcher at the Faculty of Health and Law of the Universidad Libre sectional Cali for more than 8 years.

Lina Mayerly Cruz Parra,

Electronic Engineer, specialist in Biomedical Engineering and Master in Engineering, with postgraduate studies completed at the Universidad Pontificia Bolivariana de Medellín. Currently, she holds the position of Head of the Department of Applied Sciences, in addition to being a teacher and researcher at the Metropolitan Technological Institute (ITM). She specializes in the area of Clinical Engineering, leading projects focused on technology management and biomedical metrology.

Carolina Quiroz-Arias,

Bacteriologist and clinical laboratory technician and Master in Health Administration from the Universidad del Valle.

Teacher and Researcher School of Bacteriology and Clinical Laboratory, Faculty of Health, Universidad del Valle.

He has worked for eight years in the area of quality for laboratories

Coordinator of the Quality and Metrology Research Group of the School of Bacteriology and Clinical Laboratory of the Faculty of Health of the Universidad del Valle.

Director for 3 years of the School of Bacteriology and Clinical Laboratory of the Faculty of Health of the Universidad del Valle.

Manager of the Interfaculty Master's Degree in Quality Management for Laboratories.

Accreditation

ISO 15189

Clinical laboratory

Quality managenment

Introduction. The ISO 15189:2022 standard guides the implementation of a specific quality management system for clinical laboratories. This standard allows you to obtain accreditation and demonstrate technical competence to ensure high-quality patient care. Objective. the present study evaluated compliance with the ISO 15189:2012 standard in five clinical laboratories of the public health network of the Colombian Pacific. Methodology. Through a descriptive and transversal approach, an audit was carried out using a checklist designed by the National Accreditation Body in Colombia (ONAC). Results. Significant variations are evident in compliance with the requirements, highlighting the need for a process of continuous improvement and training for the professionals involved. Conclusion. The implementation of the ISO 15189:2022 standard in laboratories in the Colombian Pacific is influenced by factors such as geographical context, complexity and staff training. Inequalities in resources affect quality standards, making specific attention necessary in laboratories with fewer resources and adaptations to the 2022 version.

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