EAGLE Registrations Inc., a third-party certification body who audits businesses to international standards, is now accredited by ANSI-ASQ National Accreditation Board (ANAB) to offer ISO 13485 certification.
“EAGLE is excited to offer accredited ISO 13485 certification to our clients,” said Albert “Skip” Greenaway, President/CEO, EAGLE Registrations. “It provides a solid business foundation, helps meet regulatory and customer requirements and creates competitive business opportunities around the world for medical device manufacturers and suppliers.”
Based on the ISO 9001 standard, ISO 13485 is an internationally-
However, the ISO 9001 elements on continuous improvement and customer satisfaction are replaced with maintaining system effectiveness and monitoring customer feedback in ISO 13485. The standard also adds risk management criteria and strengthens the requirements for process and software validation.
Businesses interested in learning more about the ISO 13485 standard or certification can contact EAGLE at 800.795.3641.
