JAVAD EMS Passes ISO 13485 2016 Recertification Audit with Zero Findings
San Jose, CA — May 2021 — JAVAD EMS (JEMS), a leading global EMS company that provides low to medium volume, high-mix applications, announces that it has successfully completed another ISO 13485:2016 recertification audit with zero findings. The company demonstrated its robust development, manufacture, distribution and control processes for medical devices. JAVAD’s Quality Management System meets the demands of legislation in every corner of the global market.
The ISO 13485 standard supplements the ISO 9001 standard and is specific to medical device quality systems. ISO 13485:2016 was published in January 2016 and supersedes ISO 13485:2012. The new version of the standard was developed to harmonize with the EU Medical Device Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
JAVAD’s state-of-the-art manufacturing software transforms product, process, materials and real-time data into total manufacturing intelligence. Each element supports the goals of speed, control and visibility throughout the process from the factory office and product launch activities, through manufacturing execution, and culminating in total traceability, reporting and monitoring.
Greg Del Brocco, Manager of Quality and Compliance, stated: “This is another significant milestone achieved by JAVAD EMS. We have now completed our last six ISO 13485 annual audits with zero findings. This is unheard of in our industry. Yes, I said unheard of, but we expect nothing less than this. We strive to be the best at everything we do. Quality here is a way of life. This is driven from top management on down. With this mentality in place, it’s no wonder we are able to achieve what we do and will continue to venture into unheard of territories going forward!”
Gary Walker, Vice President of JEMS stated: “We’re very happy to have six consecutive audits without any issues. To be able to support these needs in a low- to medium-volume high-mix environment says a lot for the quality system we have in place as well as for all the people that work here and investments we have made in equipment and software across our entire factory. As a result, all of our customers, whether they are medical based or not, get these very high-quality standard builds.”
JEMS has more than 40,000 ft.2 of manufacturing space that it continually updates to the highest standards of electronic manufacturing services, communication, client support, employee comfort, and training.