The MultiMedical Systems LLC (MMS) quality management system has earned ISO 13485:2016 certification from Orion. The three-year certification verifies that MMS – which provides medical device sales, service and repair – developed and implemented a quality management system that conforms to the international requirements for medical devices.
The independent International Organization for Standardization, based in Geneva, Switzerland and founded in 1947, develops standards across traditional industries – including manufacturing – as well as for best practices and services that align with those standards.
The ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements, which aligns with MMS’s role in maintaining diagnostic and therapeutic medical equipment and devices at clinical system partners.
MMS’s certification comes after rigorous process reviews by ISO auditors, who observed that the fundamental daily processes met the MMS quality management system which complies with the requirements of the ISO 13485:2016 standard.
“This certification further strengthens our commitment to our customers and our Company Quality Policy” said Daren Kneeland, CEO of MMS. “As an organization, we strive to understand, meet, and exceed our customer’s needs and expectations by providing medical device service of the highest possible standards, quality, safety and reliability. We are committed to the continual improvement of our services and processes, and this will be the ongoing responsibility of all MMS team members.”
“MMS already had proven service delivery processes in place, and certification confirms our efforts on formalizing our best practices into procedures that are aligned with the ISO 13485:2016,” said Raymond Reid, quality director for MMS. “This effort resulted in elevating what was already high-quality work to the next level across the MMS organization.” More…