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:
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
ISO 9001, and can also be easily integrated with other management systems such as
Once the auditing process has been successfully completed, if the implemented system meets the requirements of the standard
ISO 13485, the organisation obtains:
Furthermore, organisations with management systems certified by AENOR have free access to the
AENORnet and a subscription to the
AENOR monthly magazine.
Quality Management System for medical devices
IQNet MarkMANAGEMENT SYSTEM
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.