Published 2025-07-01
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Article (before OJS)

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

DOI: https://doi.org/10.22490/24629448.9987
Mercedes Salcedo Universidad del Valle
Lina Mayerly Cruz Instituto Técnologico Metropolitano
Miryam Escobar Universidad del Valle
Carolina Quiroz Universidad del Valle

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.

keywords: Accreditation, ISO 15189, clinical laboratory, quality management
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How to Cite

Salcedo, M. ., Cruz, L. M. ., Escobar, M. ., & Quiroz, C. . (2025). Evaluation of the ISO 15189:2012 standard in five clinical laboratories of the public health network of the colombian Pacific. NOVA Biomedical Sciences Journal, 23(44), 51-68. https://doi.org/10.22490/24629448.9987
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