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Quality Management Systems for Medical Devices UNE EN ISO 13485

Quality Management Systems for Medical Devices UNE EN ISO 13485

Quality in Medical Devices

The Standard UNE EN ISO 13485:2018 is the European version of ISO 13485:2016, specifically adapted for compliance with regulatory requirements in Europe. This international standard specifies requirements for a quality management system when an organisation needs to demonstrate its ability to manage medical devices and services that consistently meet customer and applicable regulatory requirements.

The 2018 version of the UNE-EN-ISO 13485 does not introduce substantial changes with respect to ISO 13485:2016, but represents the adoption and adaptation of the ISO standard for the European context. 

The main elements of the UNE EN ISO 13485 standard include:

  1. Risk management approach
  2. Legal and regulatory compliance
  3. Control of Suppliers and Subcontractors
  4. Documentation and Records Management
  5. Control of Monitoring and Measuring Equipment: approach to software validation
  6. Focus on Continuous Improvement
  7. Staff Training and Awareness

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

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

IQNetMANAGEMENT SYSTEM Mark

IQNet Mark
MANAGEMENT SYSTEM​

Since 2007, when the first quality management certificate in accordance with the UNE-EN ISO 13485:2004 Standard was awarded to the organisation IMMUNOSTEP, S.L., more than 80 organisations have turned to AENOR to certify their quality management system for healthcare products.