Idem Translations Upgrades ISO 13485 Quality Management System to Latest Revision

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Upgraded Certification Underscores Idem’s Commitment to its Medical Device Customers

"We hold ourselves to the same standard as our medical device clientele."

Idem Translations, Inc., the largest, triple-certified, independent provider of translation and localization services to the life sciences industry in the United States, is proud to announce the upgrade of its quality management system to ISO 13485:2016 following an audit by Orion Registrar, Inc. ISO 13485 establishes internationally-recognized principles for quality management in the manufacture of medical devices and the provision of related services. The 2016 revision marks the first major modification to the standard since 2003 and helps organizations reduce risk by increasing transparency across the supply chain. Significant changes include requirements regarding the establishment of quality agreements, supplier involvement in complaint handling, and deeper validation activities.

“For Idem, our translators are key suppliers and pivotal partners in our success. The focus on increasing supplier transparency in the new revision of ISO 13485 was a natural fit for our organization as we firmly believe that quality is a team effort,” says Mariam Nayiny, Idem’s president. “Clear communication with our translators – both in establishing expectations for quality and in collaborating to reduce the risk of error – have always been fundamental to our processes.”

Working with translators around the globe, Idem operates a quality management system that has been certified to ISO standards since 2003, including ISO 9001:2015, ISO 13485:2016, and ISO 17100, the international standard for translation services.

“We hold ourselves to the same standard as our medical device clientele,” notes Jessica Alexander, Idem’s Vice President of Quality and Operations. “Risk must be managed at every level in the process, and translations are no exception. From a customer service perspective, operating under an ISO 13485-certified quality management system helps our entire team to understand the complexities that our customers face every day in their efforts to deliver life-changing medical technologies to the markets that need them.”

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.

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Carolyn Malestic
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Idem Translations, Inc.

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