ISO 13485 – Medical devices

The International Standard ISO 13485:2016, specifies the requirements of a quality management system for the design and development, production, installation and service of medical devices. It assesses the organisation’s ability to meet regulatory and customer requirements.

The requirements specified in this standard complement the technical requirements of the products, in accordance with the applicable directive(s) for Medical Devices (Council Directive 93/42/EEC of 14 June 1993) and in Royal Decree 1591/2009 of 16 October 2009.

Based on the ISO 9001 standard, it allows integration with the organisation’s existing management system and related system requirements.


  • Identifying the processes necessary for the quality management system.
  • Determining the succession or interaction of these processes.
  • Determining criteria and methods necessary to ensure that both the operation and control of the processes are effective.
  • Ensuring the availability of resources and information necessary to support the operation and monitoring of the processes.
  • Monitoring, measuring and analysing these processes.
  • Implementing the necessary actions to achieve the planned results and maintain the effectiveness of these processes.