Access Optics Gains ISO Certification

OEM medical device and defense optics supplier Access Optics LLC has announced ISO 13485:2016 certification for its medical device and quality management systems.

The certification is a requirement for regulatory purposes and is an international standard that outlines the requirements for a quality management system specific to the medical devices industry. The new standard supports the design of a quality management system that establishes and maintains the effectiveness of a manufacturer’s processes to ensure the consistent design, development, production, installation, and delivery of medical devices or related services that are safe for their intended purpose.

“Our efforts to upgrade Access Optics’ quality management system to the new 2016 certification have helped us optimize a number of processes that will benefit both Access Optics in managing quality as well as assuring our customers of our continued commitment to quality throughout our organization,” said Robert Hogrefe, president and CEO of Access Optics.

AO is both ISO 13485:2016 certified and ITAR registered, providing an advantage to solve larger challenges while diving deeper into applications for surgical imaging, the U.S. military, and the U.S. Department of Homeland Security.