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ISO 13485 Quality Management Systems for Medical Devices
Quality Management System for Health Care Products

ISO 13485 Quality Management Systems for Medical Devices

Quality in Medical Devices

In May 2016 the new Spanish version of the STANDARD UNE-EN-ISO 13485, standard that specifies the requirements for a quality management system when an organisation needs to demonstrate its ability to manage products and services that comply with the requirements of the client and the applicable regulations.

This management system can be implemented by organisations involved in one or more phases of the life cycle of a medical device, including design and development; storage and distribution; installation, technical support and the eventual uninstallation and removal; as well as the design and development and related provision of services (technical support). Similarly, the requirements of this standard can be used by suppliers and other involved parties that supply products.

This standard is an entity in its own right, however, it is based on the standard ISO 9001:2015; the structural relationship between both versions is shown in Annex B.

The main changes to the current version are:

  • Adaptation to statutory requirements.
  • Risk-based approach for the control of all necessary processes for the quality management system.
  • Additional requirements for the validation, verification and activities of design and development.
  • Strengthening of supplier control processes.
  • More focus on feedback mechanisms.
  • Specific approach for validating software.

The certification in accordance with this standard is applicable to all organisations of any sector that are involved in activities of the life cycle of a medical device, including design, manufacture, bottling, packing, drafting and/or translation of instruction manuals, advertising, sales, distribution, user training, installation, and maintenance.

The certification in accordance with the Standard UNE-EN-ISO 13485 is compatible with and complementary to certification ISO 9001, and can also be easily integrated with other management systems such as ISO 14001, OHSHAS 18001.

Once the auditing process has been successfully completed, if the implemented system meets the requirements of the standard ISO 13485, the organisation obtains:

  • The AENOR Certificate of Quality Management Systems for Medical Devices
  • A user licence for the AENOR Mark of Quality Management Systems for Medical Devices.
  • The IQNet Certificate, passport for international access of its certification. With it, its AENOR certificate will be recognised by leading certification entities all over the world.
  • A licence to use the IQNet mark.

Furthermore, organisations with management systems certified by AENOR have free access to the AENORnet and a subscription to the AENOR monthly magazine.

UNE-EN ISO 13485 Quality Management System for Health Care Products

Quality Management System
for medical devices UNE-EN-ISO 13485​​


IQNet Mark

Since 2007, when the first quality management certificate was granted according to the standard UNE-EN-ISO 13485:2004 to the organisation IMMUNOSTEP, S.L., more than 20 organisations have certified their quality management systems for medical devices with AENOR.