Madison, Tenn.-based Tri-Imaging Solutions announces that it has received ISO 13485:2016 certification from registrar Orion for its imaging parts, equipment, and training services. To earn the certification, Tri-Imaging implemented a number of enhancements to its existing ISO 9001:2015 Quality Management System (QMS), culminating in a multi-day certification audit by Orion.
The ISO 13485:2016 standard specifies the requirements that an organization’s QMS must meet to demonstrate its ability to provide medical devices and related services that meet customer and regulatory requirements; therefore, the ISO 13485:2016 certification recognizes that the policies, practices, and procedures of Tri-Imaging ensure consistent quality in the repair and support services provided to clients, company officials say.
Eric Wright, president of Tri-Imaging Solutions, was quick to give credit to his team. “The hard work and dedication to complete our certification in such a timely manner is a great reflection of the Tri-Imaging team,” Wright says. “Our strength comes from more than 320 years combined industry experience among this knowledgeable team.”