El objetivo principal de la norma ISO 15189:2022 – Laboratorios Médicos: Requisitos de calidad y competencia es fomentar el bienestar de los pacientes y la satisfacción de los usuarios de laboratorios, generando confianza en la calidad y competencia de los laboratorios médicos.

Después de un período de diez años, se ha llevado a cabo una actualización técnica de la norma ISO 15189, la cual establece los requisitos de calidad y competencia que deben cumplir los laboratorios médicos. Esta norma incluye requerimientos para que los laboratorios médicos planifiquen e implementen acciones orientadas a abordar riesgos y aprovechar oportunidades de mejora. Además de ser aplicable a laboratorios médicos en el desarrollo de sus sistemas de gestión y evaluación de competencia, la norma ISO 15189 también resulta relevante para usuarios, autoridades reguladoras y organismos de acreditación encargados de confirmar o reconocer la competencia de los laboratorios médicos.

Los beneficios derivados de la aplicación de esta norma incluyen: incrementar la efectividad del sistema de gestión, reducir la probabilidad de obtener resultados inválidos y disminuir los posibles daños a pacientes, personal de laboratorio, público y medio ambiente. La versión ISO 15189:2022 cancela y reemplaza a su edición previa, ISO 15189:2012, e introduce cambios significativos, como la alineación con la norma ISO/IEC 17025:2017, la incorporación de requisitos para pruebas en el punto de atención (POCT) y un mayor énfasis en la gestión de riesgos. También se han actualizado los requisitos relacionados con el equipo utilizado en los laboratorios, destacando medidas de gestión de riesgos. La nueva versión de la norma incluye nuevos términos y definiciones, y se han realizado cambios en la documentación del sistema de gestión, con subsecciones específicas sobre el control de documentos y la retención de registros.

A diferencia de la edición anterior de ISO 15189, que presentaba una estructura de listas y puntos en sus secciones de gestión, la versión actual es más específica en cuanto a la redacción de los requisitos de gestión de calidad. Un cambio significativo en la nueva norma ISO 15189 es el enfoque en la gestión de riesgos dentro del sistema de gestión de calidad de un laboratorio. En este sentido, se establece que la dirección del laboratorio debe establecer, implementar y mantener procesos para identificar riesgos de daño a los pacientes y oportunidades de mejora en la atención a los pacientes asociadas a sus exámenes y actividades, y desarrollar acciones para abordar tanto los riesgos como las oportunidades de mejora. Además, se requiere que el director del laboratorio evalúe la efectividad de estos procesos y los modifique en caso de resultar ineficaces.

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