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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 ...
Salcedo, Mercedes +3 more
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, 2013 To validate and accredit a set of three multiplex endpoint PCR assays, targeting the most important carbapenemase and minor extended-spectrum β-lactamase (ESBL) resistance genes, according to the international ISO 15189 particular requirements for the ...
de Mendonça, R. +11 more
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ABSTRACT Revised ISO 15189 was published in December 2022. In SIPMeL Recommendations M1, requirements are presented from chapters 5 (organization and management requirements) and 8 (management system requirements). The M1 Recommendations consider it necessary to refer to other ISO documents, not all of which are cited in ISO 15189.
openaire +1 more source
Excellence in clinical laboratories: the standard ISO 15189:2007
Microbiologia Medica, 2010 I laboratori clinici operano in stretto contatto con i pazienti e collaborano direttamente alla loro cura, in modo corresponsabile con i medici e i reparti ospedalieri.
Antonio Scipioni +3 more
doaj +1 more source
How ISO-15189 laboratory accreditation assures patient safety? [PDF]
Journal of Medical Biochemistry, 2012 Healthcare is a complex profession involving the state-of-art technology and sometimes leading to unintentional harm. Many factors contribute to the occurrence of medical errors.
Serteser Mustafa +3 more
doaj
Diagnóstico del cumplimiento de la Norma ISO 15189:2008 en la empresa Laboratorios Guerrero
, 2012 Objetivo general: Evaluar el cumplimiento de la Norma ISO 15189:2008 en la empresa Laboratorios Guerrero para determinar las áreas de ...
Fernández García, Justo
core
Quality assurance and technical competence in a clinical laboratory based on NTC / ISO 15189: 2014
, 2021 Clinical laboratories that adopt a quality management system based on the NTC / ISO 15189: 2014 present different challenges, success in achieving these challenges requires the skills and commitment of all staff to fulfill tasks, improve quality and ...
Pinto Ortegón, Laura Cristina
core
THE MANAGEMENT OF MEDICAL ANALYSIS LABORATORIES AND BIOLOGICAL RISK PREVENTION [PDF]
Journal of Defense Resources Management, 2013 The increasing number of reports on biological terrorist threats identified at international level raised serious challenges not only for the scientists but also for people responsible of population health.
Mihaela BARCAN
doaj
Procesos de soporte y su influencia en la acreditación ISO 15189:2022 en dos laboratorios clínicos de Lima, 2024 [PDF]
La ISO 15189 surge como una norma enfocada en asegurar la confiabilidad de los procesos y los resultados del laboratorio clínico, priorizando la seguridad del paciente, estos lineamientos se encuentran alineados con el ODS 3: Promoción de la Salud y ...
Gutierrez Loaiza, Yoany Andrea
core
Journal of Laboratory MedicineEnsuring result comparability across identical analyzers is critical in high-throughput clinical laboratories. ISO 15189:2022 emphasizes this requirement (clause 7.3.7.4), particularly for assays with low within-subject biological variation (BV), where ...
Doruk Özlem Gürsoy +6 more
doaj +1 more source