ISO 13485:2003

“Due to compliance implications for the essential requirements of the MDD and the IVDD, Notified Bodies consider translation to be an ‘important outsourced service’…This makes translation providers subject to the outsourced vendor risk management considerations of ISO 13485:2003 and ISO 14971.” KEMA

Excel Translations is pleased to announce it has received the ISO 13485:2003 certification, effectively aligning its quality processes with its clients’ in the medical device, diagnostic, hospital supply, and dental supply industries. BSI Management Systems America, Inc., a leading global provider of management systems assessment and certification solutions, has awarded Excel Translations the ISO 13485 certification for its translation services. ISO 13485:2003 demonstrates the existence of an effective quality system that satisfies the rigors of an independent, external audit and addresses the additional safety, regulatory, and quality concerns specific to the medical device industry.

The decision of Excel Translations — already certified to global quality standard ISO 9001 since 2000 — to pursue certification to ISO 13485:2003 is explained by president Hervé Rodriguez: "For eight years we have been operating in an ISO 9001:2008-certified controlled environment. Our intent with ISO 13485 is to better align ourselves with the medical device industry and to provide additional reassurance to our clients and prospects that, indeed, their projects are in good hands with us. We are proud to offer our clients both certifications in order to seamlessly integrate with their quality processes."

ISO 13485:2003 helps provide a framework for implementation of actions to ensure achievement of planned results and to ensure maintenance of effectiveness of those processes with customer, quality and regulatory requirements. Due to the nature of medical devices, safety is the principal objective. Whereas ISO 9001:2008 seeks continuous improvement, the intent of ISO 13485:2003 is to get it right from the beginning.

"ISO 13485 is an unforgiving, black-and-white standard," says Rob de Cortie, Manager of Quality Assurance at Excel Translations. "It does not allow for companies to have poor quality or an ineffective process that they can improve upon. Instead, it demands an effective system resulting in a high-quality product from the get-go. We want to assure medical device manufacturers that the same safety, regulatory compliance and care that they apply in order to design and manufacture the best possible device goes into translating the literature that accompanies medical devices."

About 13485:2003

ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The ISO 13485:2003 standard is globally recognized as the best quality practices from organizations within the medical device industry.