JAVAD EMS Passes ISO13485: 2016 Annual Surveillance Audit with Zero Findings

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JAVAD EMS (JEMS), a leading global EMS company that provides low- to medium-volume, high-mix applications, announces that it has successfully completed another ISO13485:2016 recertification audit with zero findings. The company demonstrated its robust development, manufacture, distribution and control processes for medical devices. JEMS’s Quality Management System meets the demands of legislation in every corner of the global market.

The ISO13485 standard supplements the ISO9001 standard and is specific to medical device quality systems. ISO13485:2016 was published in January 2016 and supersedes ISO13485:2012. 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.

JEMS’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.

“Seven years and going! Yes, that is seven years straight with no non-conformances found by our external auditors,” commented Greg Del Brocco, Manager of Quality and Compliance. “At JEMS, quality is built into everything we do. It’s a culture here and it starts from the top management and goes all the way down. If it wasn’t, we wouldn’t be enjoying the success that we are obtaining. As it is part of our culture, we will be able to continually meet and exceed our goals.”

Gary Walker, Vice President of JEMS, stated: “We’re very happy to have seven 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 sq ft of manufacturing space that it continually updates to the highest standards of electronic manufacturing services, communication, client support, employee comfort and training.