Raising the Bar: On the Path Towards ISO 17100:2015 and ISO 13485:2016

This quarter marks a major milestone in the AbroadLink’s development as a top-tier translation service provider. Next quarter, our ISO 9001 certification will be five years old. It was a good time to raise the bar and offer our clients the quality assurances provided by the ISO 17100:2015 standard for translation services, and the ISO 13845:2016 standard for medical devices.

What is the ISO 17100:2015 standard?

This standard replaces the old ISO 15038:2006 quality standard for translation services. A main feature introduced by the old standard and maintained by the updated one is that the translation process involves a review step. That is, the translation is initially carried out by a translator and then reviewed by a second professional. Other characteristics of this standard are the specifications regarding the qualifications that translators must have. When AbroadLink developed the quality manual for ISO 9001 in 2013, the process was prepared to comply with the then ISO 15038:2006, which is now facilitating the implementation of the new version of the standard for translation services.

What is the ISO 13485:2016 standard?

This is a standard specific to the healthcare sector, particularly for the quality management of medical devices. So, why are we at AbroadLink interested in being certified under this standard? The reason is clear: we want to tell all our clients who produce or market medical devices that quality is of great importance to us as a provider and that our translation services for manuals, websites, software, etc., comply with a standard widely adopted by the sector. The key element introduced by this standard compared to ISO 9001 within the management of AbroadLink is the requirements for selecting translators specialised in medical device translation.