Oliver Medical, Grand Rapids, Mich., received ISO 13485:2003 certification. ISO 13485:2003 outlines a quality management system for organizations that provide medical devices and related services. Compliance with ISO 13485:2003 increases the likelihood of an organization meeting various international regulatory requirements.

TÜV SÜD America Inc., Peabody, Mass., received accreditation from the Standards Council of Canada (SCC) and the ANSI-ASQ National Accreditation Board (ANAB) for ISO/IEC 17021. The standard governs requirements for certification bodies. The new standard requires a two-stage audit for initial certification. It also introduces a new requirement that prohibits a certification body from issuing a certificate to an organization with minor nonconformities until it has reviewed and accepted the organization's corrective and preventive action plan. The existing requirement for closing major nonconformities remains unchanged.

Atek Medical, Grand Rapids, Mich., announced that its 33,000-sq.-ft. medical-device manufacturing facility in Heredia, Costa Rica, is ISO-13485:2003 certified. It is also registered with the FDA. The certification is base on an inspection by TÜV SÜD America Inc.