Broken Arrow, OK, August 28, 2018 --(PR.com
)-- Access Optics LLC. (AO), a leading OEM supplier for medical device and defense optics, announces their ISO 13485:2016 certification for Medical Device and Quality Management Systems. This 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.
According to AO’s certifying body, BSI, 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 which 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 + CEO of Access Optics.
AO is one of the few manufacturers to be both ISO 13485:2016 certified and ITAR registered. This gives AO the advantage to solve bigger challenges, taking them deeper into applications for surgical imaging and into new applications for the U.S. Military and Department of Homeland Security.
Key changes to ISO 13485:2016 include:
· Alignment of global regulatory requirements.
· Inclusion of risk management and risk-based decision making throughout the quality management system.
· Additional requirements and clarity concerning validation, verification, and design activities.
· Strengthening of supplier control processes.
· Increased focus regarding feedback mechanisms.
For two decades AO has provided exceptional precision optics and medical devices to the leading manufacturers of surgical imaging systems across the world. With a combined experience of more than 150 years, the management team at AO is fully equipped to bring the medical device industry into the next frontier of optics.