Iso 13485

Our commitment to quality is an unconditional foundation at Ortoibérica S.L. not only of its products but also of its service. For this, the company is certified in the ISO 13485: 2016 standard and audited by Lloyds.

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

This management system can be applied by organizations involved in one or more stages of the life cycle of a medical device, such as design and development; storage and distribution; installation, support, and final uninstallation and removal; as well as the design and development and the provision of related services (technical support). The requirements of this standard can also be used by suppliers and other interested parties that provide the product.