Certification under ISO 13485 & ISO 17100

Quality and reliability are our top priorities, even more so as the majority of our work is on products which are safety-critical. That's why ADAPT Localization Services GmbH was one of the first companies to be successfully certified by LinquaCert, the Swiss certification authority, under the then newly introduced translation services standard ISO 17100, and why we also sought certification under ISO 13485 which we received from TÜV Hessen.

Requirements of ISO 17100

EN ISO 17100:2015 is the current professional standard for translation companies. It establishes fundamental requirements for translation projects and focuses mainly on production processes, including qualification requirements for translators, reviewers and project managers, as well as the structural workflow of translation projects. Certification audits also concentrate on information security and, in particular, the handling of customer data.

Continuous adherence to the the provisions of the norm are verified in annual audits.

Requirements of ISO 13485

EN ISO 13485:2016 is the quality management norm for manufacturers of medical products and services which relate to them. It requires to base all processes on a risk analysis, which we perform in accordance with ISO 14971, and sets high standards for meeting both customer and regulatory requirements and for documenting all relevant processes and activities.

Continuous and consistent compliance of our quality management system with the requirements of ISO 13485 is demonstrated in yearly surveillance audits.  

Here you can download our ISO 13485 and ISO 17100 certificates