NLG earns ISO 13485 certification

June 16, 2015  |  Press Release

Hallbergmoos/Thessaloniki, 15 June 2015

NLG GmbH, a leading language services provider to global clients across life sciences, is pleased to announce that the company recently earned the ISO 13485:2012 quality certificate after a successful on-site audit by the certifying body TÜV Austria Hellas. Through the audit NLG’s quality management system and processes were found to have no deficiencies to the requirements of the standard.

The increasing regulatory environment of the healthcare industry has a significant impact on the language services industry, especially for providers like NLG who are heavily integrated with global healthcare companies. While NLG has been certified to ISO 9001:2008 and the translation industry specific EN 15038 since 2007, the ISO 13485:2012 certification required NLG to demonstrate a higher level of commitment and sophistication in operations including:

  • Risk management through all stages of service realization
  • Having knowledge of and meeting regulatory and client requirements
  • Maintaining the continued suitability and effectiveness of NLG’s quality management system in alignment with client requirements.

“While we believe that quality means much more than holding a certificate, at the same time we know that especially our medical clients wish to have the official affirmation. It’s rather unusual for a Language Service Provider to undergo the ISO 13485 audit. It is a standard relating to the Quality Management  System for organizations involved in the manufacture of Medical Devices.” says Nana Lachanidou, director of quality & compliance at NLG.

“The fact that NLG underwent this audit, and very successfully at that, simply shows that we do whatever we can to maintain being an attractive business partner“, adds Michael Oettli, Managing Director of NLG.

The next step within NLG’s ongoing goal for meeting the highest standards of quality for its clients will be certification to ISO 17100:2015. This new ISO standard is replacing the current EN 15038 certification, specifically created for language service providers. NLG’s management is very confident that the transition from EN 15038 to ISO 17100:2015 will be equally successful as the recent ISO 13485 certification process.