Quality Magazine

QMI Offers ISO 13485 audits

December 8, 2004
CLEVELAND—QMI, a North American management systems registrar, announces its accreditation by the Standard Council of Canada to perform ISO 13485: 2003 audits. All medical device manufacturers applying for or maintaining a valid license for Class II, Class III or Class IV medical devices will be required by Health Canada to register to ISO 13485: 2003 under the Canadian Medical Devices Conformity Assessment System by March 15, 2006.

The company also has partnered with a European Notified Body to conduct audits in compliance with European directives for medical devices in North America. Until ISO 13485: 1996 and ISO 13488: 1996 under CMDCAS expire in July 2006, QMI will continue to offer those registrations as well.