INTERNATIONAL STANDARDS IN THE HEALTH SECTOR: IMPACT ON THE QUALITY OF MEDICAL AND DIAGNOSTIC DEVICES

Autores/as

  • Antonieta Peralta Santamaría Pediatrician / Master in Quality Management / Independent Consultant Autor/a

Resumen

N/A

Referencias

Alvarado Cuenca, R. I. (2024). Normas ISO en gestión sanitaria: revisión sistemática. Ciencia Latina Revista Científica Multidisciplinar, 8(4), 5035–5058. https://doi.org/10.37811/cl_rcm.v8i4.12727

Asamblea Legislativa de El Salvador. (2023). Ley de compras públicas. Diario Oficial de El Salvador. Consejo Nacional de Calidad. (s. f.). Marcoinstitucional. https://cnc.gob.sv/marcoinstitucional/

Corte de Cuentas de la República. (2025). Capacitación sobre sistema de gestión antisoborno ISO 37001. https://www.cortedecuentas.gob.sv

European Committee for Standardization. (2019). EN 14683: Medical face masks—Requirements and test methods.

International Organization for Standardization. (2015). ISO 9000:2015 quality management systems—Fundamentals and vocabulary.

International Organization for Standardization. (2016). ISO 13485: Medical devices—Quality management systems—Requirements for regulatory purposes.

International Organization for Standardization. (2019). ISO 14971: Medical devices—Application of risk management to medical devices. International Organization for Standardization. (2023a). The ISO survey of management system standard certifications. https://www.iso.org

International Organization for Standardization. (2023b). ISO standards for medical devices and healthcare technologies. https://www.iso.org

Medtecs Business Solutions. (2022). What is EN 14683? The European standard for face masks! https://business.medtecs.com/en14683/

Organismo Salvadoreño de Normalización. (2025). Acreditación del organismo salvadoreño de normalización bajo la ISO 37001. https://www.osn.gob.sv

Perdomo, A. (2024). ISO survey 2024: Tendencias y desafíos para El Salvador y Centroamérica.

Plebani, M. (2010). The detection and prevention of errors in laboratory medicine. Annals of Clinical Biochemistry, 47(2), 101–110. https://doi.org/10.1258/acb.2009.009222

Sistema Salvadoreño para la Calidad. (2011). Ley de creación del Sistema Salvadoreño para la Calidad. Diario Oficial de El Salvador.

World Health Organization. (2020). WHO good distribution practices for pharmaceutical products. https://www.who.int

World Health Organization. (2021). Medical device regulations and standards. https://www.who.int

World Health Organization. (2023). Technical specifications for pre-market assessment of medical masks. https://iris.who.int

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Publicado

2026-08-07

Número

Sección

ARTÍCULO DE ENFOQUE REGULATORIO