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

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Title: Evaluación del estándar ISO 15189:2012 en cinco laboratorios clínicos de la red de salud pública del pacífico colombiano.
Alternate Title: Evaluation of the ISO 15189:2012 standard in five clinical laboratories of the public health network of the colombian pacific.
Authors: Salcedo, Mercedes1 mercedes.salcedo@correounivalle.edu.co, Mayerly Cruz, Lina2, Escobar, Miryam3, Quiroz, Carolina1
Source: NOVA: Publicación Científica en Ciencias Biomédicas. ene-jun2025, Vol. 22 Issue 44, p51-68. 18p.
Subjects: CONTINUOUS improvement process, PATHOLOGICAL laboratories, TOTAL quality management, QUALITY standards, HEALTH care networks
Abstract (English): 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. [ABSTRACT FROM AUTHOR]
Abstract (Spanish): Introducción. La norma ISO 15189:2022 orienta la implementación de un sistema de gestión de calidad específico para los laboratorios clínicos. Esta norma permite obtener la acreditación y demostrar competencia técnica para asegurar una atención al paciente de alta calidad. Objetivo. El presente estudio evaluó el cumplimiento del estándar ISO 15189:2022 en cinco laboratorios clínicos de la red de salud pública del Pacífico colombiano. Metodología. A través de un enfoque descriptivo y transversal, se realizó una auditoría utilizando una lista de chequeo diseñada por el Organismo Nacional de Acreditación en Colombia (ONAC). Resultados. Se evidencian variaciones significativas en el cumplimiento de los requisitos, destacando la necesidad de un proceso de mejora continua y de capacitación para los profesionales involucrados. Conclusión. La implementación de la norma ISO 15189:2012 en laboratorios del Pacífico colombiano está influenciada por factores como el contexto geográfico, la complejidad y la capacitación del personal. Las desigualdades en recursos afectan los estándares de calidad, haciendo necesaria una atención específica en laboratorios con menos recursos y adaptaciones a la versión 2022. [ABSTRACT FROM AUTHOR]
Copyright of NOVA: Publicación Científica en Ciencias Biomédicas is the property of Universidad Colegio Mayor de Cundinamarca and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
Database: MedicLatina
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  Data: Evaluación del estándar ISO 15189:2012 en cinco laboratorios clínicos de la red de salud pública del pacífico colombiano.
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  Data: Evaluation of the ISO 15189:2012 standard in five clinical laboratories of the public health network of the colombian pacific.
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  Data: <searchLink fieldCode="AR" term="%22Salcedo%2C+Mercedes%22">Salcedo, Mercedes</searchLink><relatesTo>1</relatesTo><i> mercedes.salcedo@correounivalle.edu.co</i><br /><searchLink fieldCode="AR" term="%22Mayerly+Cruz%2C+Lina%22">Mayerly Cruz, Lina</searchLink><relatesTo>2</relatesTo><br /><searchLink fieldCode="AR" term="%22Escobar%2C+Miryam%22">Escobar, Miryam</searchLink><relatesTo>3</relatesTo><br /><searchLink fieldCode="AR" term="%22Quiroz%2C+Carolina%22">Quiroz, Carolina</searchLink><relatesTo>1</relatesTo>
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  Data: <searchLink fieldCode="JN" term="%22NOVA%3A+Publicación+Científica+en+Ciencias+Biomédicas%22">NOVA: Publicación Científica en Ciencias Biomédicas</searchLink>. ene-jun2025, Vol. 22 Issue 44, p51-68. 18p.
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  Data: <searchLink fieldCode="DE" term="%22CONTINUOUS+improvement+process%22">CONTINUOUS improvement process</searchLink><br /><searchLink fieldCode="DE" term="%22PATHOLOGICAL+laboratories%22">PATHOLOGICAL laboratories</searchLink><br /><searchLink fieldCode="DE" term="%22TOTAL+quality+management%22">TOTAL quality management</searchLink><br /><searchLink fieldCode="DE" term="%22QUALITY+standards%22">QUALITY standards</searchLink><br /><searchLink fieldCode="DE" term="%22HEALTH+care+networks%22">HEALTH care networks</searchLink>
– Name: Abstract
  Label: Abstract (English)
  Group: Ab
  Data: 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. [ABSTRACT FROM AUTHOR]
– Name: Abstract
  Label: Abstract (Spanish)
  Group: Ab
  Data: Introducción. La norma ISO 15189:2022 orienta la implementación de un sistema de gestión de calidad específico para los laboratorios clínicos. Esta norma permite obtener la acreditación y demostrar competencia técnica para asegurar una atención al paciente de alta calidad. Objetivo. El presente estudio evaluó el cumplimiento del estándar ISO 15189:2022 en cinco laboratorios clínicos de la red de salud pública del Pacífico colombiano. Metodología. A través de un enfoque descriptivo y transversal, se realizó una auditoría utilizando una lista de chequeo diseñada por el Organismo Nacional de Acreditación en Colombia (ONAC). Resultados. Se evidencian variaciones significativas en el cumplimiento de los requisitos, destacando la necesidad de un proceso de mejora continua y de capacitación para los profesionales involucrados. Conclusión. La implementación de la norma ISO 15189:2012 en laboratorios del Pacífico colombiano está influenciada por factores como el contexto geográfico, la complejidad y la capacitación del personal. Las desigualdades en recursos afectan los estándares de calidad, haciendo necesaria una atención específica en laboratorios con menos recursos y adaptaciones a la versión 2022. [ABSTRACT FROM AUTHOR]
– Name: AbstractSuppliedCopyright
  Label:
  Group: Ab
  Data: <i>Copyright of NOVA: Publicación Científica en Ciencias Biomédicas is the property of Universidad Colegio Mayor de Cundinamarca and its content may not be copied or emailed to multiple sites without the copyright holder's express written permission. Additionally, content may not be used with any artificial intelligence tools or machine learning technologies. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract.</i> (Copyright applies to all Abstracts.)
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        Value: 10.22490/24629448.9987
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      – Code: spa
        Text: Spanish
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    Subjects:
      – SubjectFull: CONTINUOUS improvement process
        Type: general
      – SubjectFull: PATHOLOGICAL laboratories
        Type: general
      – SubjectFull: TOTAL quality management
        Type: general
      – SubjectFull: QUALITY standards
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      – SubjectFull: HEALTH care networks
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              Text: ene-jun2025
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              Y: 2025
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