ISO13485: INL successfully concluded the first certification cycle

February 28, 2023

Last December, INL – International Iberian Nanotechnology Laboratory successfully concluded the first certification cycle of all activities developed by the Micro and Nanofabrication (MNF) Facility related to design, development and testing of nanotechnology-based solutions for use in medical devices, in accordance with the international standard ISO 13485. This standard specifies the requirements for a management system where an organization needs to demonstrate its ability to provide Medical Devices and related services that consistently meet customer and applicable regulatory requirements.

SGS Spain conducted the final certification audit, and we managed to achieve the remarkable result of 0 nonconformities during the entire three-year cycle. This was a significant milestone successfully achieved by the Facility and INL – International Iberian Nanotechnology Laboratory last year.

During the last three years, ISO 13485 certification was – and continues to be of a major benefit for INL, as it enables access to a key market, gaining customers’ trust and achieving international quality recognition, as this certification is not only preferred but required.

Quality is in INL genetic code

The attribution of ISO 13485 certification is only the latest development of a journey dedicated to certifying INL operations according to internationally recognized standards. 

July 2020 marked the full implementation and the external certification of INL Research, Development and Innovation Management System, establishing an Innovation model, supported by interfaces and interactions between the scientific and technological knowledge, the knowledge about the organization, the market, and the society.  

It was designed according to the NP 4457 standard, which defines the requirements of effective management of Research, Development, and Innovation (RDI), allowing organizations that adopt this standard to define an RDI policy and achieve their innovation objectives, in a process where INL Business and Strategic Relations, Research Office and Intellectual Property areas had a key role.

The implementation and certification of these standards add to the already mature INL Quality Management System – first certified according to the well-known ISO 9001 in 2017, and which also successfully entered the second three-year certification cycle achieving the first certificate renewal – leading to the creation of INL Integrated Management System, comprising processes, requirements, and standards of different scopes and natures, all intrinsically articulated to result in a unified framework oriented towards common objectives. 


Interdisciplinarity is key to INL success in Quality 

All these meaningful achievements were only possible with the collaboration of the certification project leaders, process owners, more than 60 direct participants, and the remarkable commitment with quality and excellence of more than 300 Members of the Personnel. Thanks to the committed work and dedication of all the ones involved, INL has achieved all certifications with zero nonconformities since the first audit, back in 2017, which is considered to be an exceptional result.

Furthermore, INL is now one of the very few Research and Technology Organizations worldwide with QMS certification, now adding the RDI and Medical Devices to this uncommon record.