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REDCOM EMS, a business unit of REDCOM Laboratories, Inc., announced today that the company has secured ISO 13485:2016 certification, indicating its Quality Management System meets all the requirements for medical device manufacturing. The certification complements the company’s existing ISO 9001:2015 and AS9100D certifications.
“As the need for medical equipment is more important than ever, REDCOM EMS is well positioned with the recent addition of the ISO 13485:2016 certification for our Quality Management System,” said Steve Husband, Vice President of Manufacturing, REDCOM and General Manager, REDCOM EMS. “With this additional certification, REDCOM EMS is pleased to offer our electronic manufacturing services to the medical device industry. This certification, along with the AS9100D:2016 and the ISO 9001:2015, is a true testament to our commitment of providing a quality product to a very diverse customer base.”
Quality Engineer and Millennial in Manufacturing award winner Lauren Iuranich led the team in obtaining this certification. “This certification, in conjunction with the AS9100D certification we received last year, highlights our commitment to quality and delivering safe, mission-critical products to our customers,” Iuranich remarked. As a Quality Engineer, she’s continuously driving REDCOM EMS into the future by improving processes and systems throughout the manufacturing environment and attaining the necessary certifications.
“Our ability to obtain two certifications in less than a year demonstrates the robustness of our Quality Management System. Managing two unique sets of requirements can be challenging for small companies, but REDCOM EMS prioritizes quality and has a dedicated group of highly motivated employees to maintain requirements and produce high-quality products,” stated Iuranich.
REDCOM EMS’s ISO 13485:2016 certificate (SX 60149223) became effective on May 8, 2020, and was issued by TUV Rheinland, a certification body and global leader in independent quality inspection services. Maintaining the certification will require rigorous and comprehensive audits by the internal team and annual validation by a third-party certifying body to ensure compliance with the standard.