Tri-Imaging Solutions, a leader in imaging parts and training, 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 International Organization for Standardization (ISO) is the world’s largest developer and publisher of international standards for the implementation of QMSs and various other technical and operational standards.
“Earning the certification demonstrates Tri-Imaging’s commitment to delivering the highest quality parts and service support to the medical imaging industry. They are now able to further ensure the effectiveness of their processes in following the same guidelines as medical device manufacturers,” according to a news release.
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 consistently meet customer and regulatory requirements.
“With the ISO 13485:2016 certification, customers can be confident that Tri-Imaging is dedicated to maintaining the highest level of quality, efficiency and responsiveness to achieve the company’s ultimate goal of superior customer satisfaction,” according to the release. “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.”
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 said. “Our strength comes from more than 320 years combined industry experience among this knowledgeable team.”
Tri-Imaging is an independently owned diagnostic imaging parts, technical training, technical support and support services company for the diagnostic imaging market.