ISO 13485:2003

Excel Translations is pleased to announce it is right on target to become certified to the ISO standard 13485:2003 in the fourth quarter of 2008.  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 9001:2000 since 2000– to pursue ISO 13485 is explained by president Hervé Rodriguez. “For eight years, we have been operating in a controlled, high-quality environment that is ISO 9001:2000. 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.”

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 9001:2000 seeks continuous improvement, the intent of ISO 13485 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. “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 –or maybe I should say patients worldwide– that the same safety, regulatory compliance and care that they apply in order to design and manufacture the best possible medical device goes into translating the software and literature that accompanies medical devices.

The International Organization for Standardization (ISO) is a worldwide federation of national standards bodies from some 130 countries, one from each country. ISO is a non-governmental organization established in 1947. The mission of ISO is to promote the development of standardization and related activities in the world with a view to facilitating the international exchange of goods and services, and to developing cooperation in the spheres of intellectual, scientific, technological and economic activity. ISO's work results in international agreements which are published as International Standards.

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.

Since 1996, Excel Translations has been specializing in the globalization needs of regulated companies in the life sciences and healthcare industries. We work with Fortune 1000 companies in the Medical Device Manufacturing, Biotechnology, IVD, and Pharmaceutical Industries as well as with Contract Research Organization (CROs) and have tailored our ISO 9001:2000-certified translation processes to meet the specific requirements of these industries. We have become the preferred translation partner of life sciences and healthcare companies, large and small, in the US, Asia and Europe.

For more information, contact: Hervé Rodriguez, Founder & President, at hrodriguez@xltrans.com