June 1, 2018

As of May 2018, we are ISO 13485:2016 Certified

We are proud to announce that Pangeanic has successfully passed external audits by British Quality Certification body EQA to add ISO 17100:2015 (replacing EN 15038) and ISO 13485:2016 to our ISO 9001:2015 certification. Pangeanic continues to assure its clients with certified translations through its accreditations, as these three standards focus on checking Pangeanic’s translations procedures and systems in our continuous commitment to providing the best quality translation service.


 
While the transition towards ISO 17100:2015 from EN 15038 was a natural step in our industry, the addition of ISO 13485:2016 is a major upgrade in our quality system. Pangeanic has been ISO 13485:2016 certified as an additional step towards excellence in medical device translations. Our ISO 9001:2015 certification assures quality management; ISO 17100 certification assures the translation process itself, and ISO 13485 establishes a more specific framework for the medical devices to be used by manufacturing companies.

 

“Through our partnerships with some of the most important life sciences companies in the world, we have strengthened our commitment to our partners by demanding a stricter emphasis on control through our internal quality management systems (QMS), by obtaining the ISO 13485 accreditation. Pangeanic’s QMS allows no room for errors in planning, processes, resources and finally translation which in turn ensures consistently high-quality standards.” Garth Hedenskog –Sales and Marketing Director at Pangeanic

 

Pangeanic, as a certified company under this standard, has documented procedures for both specialized linguists in the healthcare sector and the translation process in order to ensure quality and excellence to all of our clients.

Pangeanic was first certified in 2007 with EN 15038 (predecessor to the ISO 17100 standard). Since then, we systematically control all our processes, from human resources to staff training, translation quality control, documentation control and traceability for specific translation services.

Pangeanic has proven diligence in these certification processes, together with extensive experience in translation project management acquired since 1997. As a global company, our clients in Asia, Europe, the US, Canada, Latin America, Gulf countries, North Africa, India, Singapore … in fact more than 40 countries can certify our commitment, so next time you think languages, think Pangeanic

2 thoughts on “New ISO 13485 for medical devices

  1. Chandana Gurung Bhandari

    NordicNeuroLab AS has been using the translation service and have Pangeanic as an approved supplier. We therefore want the updated certificates for ISO 13485:2016 and ISO 9001:2015 as soon as possible.

    Reply

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