1 week ago
October 12, 2021
Idem Translations Achieves Quality Management System Recertification for ISO 9001 and ISO 13485
Idem Remains Committed to Excellence in Customer Service and Continual Improvement of its Processes
Idem Translations, Inc. is proud to announce the recertification of its quality management system to ISO 9001:2015 and ISO 13485:2016 following a September audit by Orion Registrar, Inc.
“A deep and abiding belief in quality management is a core tenet in the Idem corporate philosophy. We have never been satisfied with ‘good enough’,” says Mariam Nayiny, Idem’s founder and President. “Our entire team is deeply committed to not only serving our customers, but exceeding their expectations on each and every translation we deliver.”
ISO 9001, the international standard for quality management system requirements, helps organizations function more efficiently and improve customer satisfaction by establishing reliable processes and improving them year over year. ISO 13485 establishes internationally-recognized principles for quality management in the manufacture of medical devices and the provision of related services. Idem’s quality management system has been certified to ISO 9001 since 2003 and to ISO 13485 since 2012.
“We are proud to be the largest, triple-certified, independent provider of translation and localization services to the U.S. life sciences industry,” adds Nancy Kellen, Idem’s Vice President of Client Services. “Many of our customers are navigating the MDR transition and we are proud to leverage the principles of ISO 13485 in support of their efforts.”
In addition to ISO 9001 and ISO 13485, Idem holds certification to ISO 17100, the international standard for translation services.
About Idem Translations
Founded in 1983, Idem Translations, Inc. is a full-service provider of translation and localization services. Idem specializes in certified translations for medical device, biomedical, and pharmaceutical companies, as well as other organizations and entities working in the life sciences sector, such as contract research organizations, healthcare research centers, and institutional review boards. The company is a WBENC-certified, women-owned business and holds certifications to ISO 9001:2015, ISO 13485:2016, and ISO 17100:2015.
About Orion Registrar
Orion was founded in 1994 by auditors who realized a need and came together to provide the most professional and fair certification service possible. Orion is accredited by the ANSI-ASQ National Accreditation Board (ANAB) and committed to providing third party certification services that meet or exceed the needs and expectations of their customers. Orion looks at the relationships with their clients as investments of time and excellence. They are proud of these clients and the hard work they have done to become certified, thereby improving service, quality, and overall value in their field.