Implementación de la Norma ISO 13485 en Laboratorios de Verificación de Equipamiento Médico

  • María Estefanía Sánchez
  • Johanna Casado
  • Gastón Jarén


In order to verify the good functionality of medical equipment (life support or even routine related equipment) is very important the existence of medical equipment verification laboratories. Due to its great importance we find the need to apply the Quality Management System (ISO 13485) to these entities in order to ensure the good management and traceability of the tasks performed. In Mendoza-Argentina, BIOIEM is a medical equipment verification laboratory of the University of Mendoza. BIOIEM accepted the offer to contribute to the investigation, so that the application of a Quality Management System could be carried out. After the analysis we were able to contribute to this institution with all the material generated for the fulfillment of the standard. 
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