KEP has achieved ISO 13485:2016 certification for Medical Device and Quality Management Systems. This ISO certification indicates that we meet the most current quality system requirements specific to the medical device industry.
An internationally recognized quality standard, ISO 13485:2016 establishes the requirements for a comprehensive system for the manufacturing processes of medical devices. Through an independent 3rd party assessment, achieving the certification demonstrates our commitment to quality standards and exceeding customer expectations.
“Audits offer a great opportunity to challenge our existing processes and harvest more improvement ideas,” said Beverly Kiglics, our Senior Director of Quality Assurance. “ISO 13485:2016 validates KEP’s credibility in the medical markets and shows that we take quality very seriously.”
At our ISO 13485:2016 certified facilities in Kent, Mogadore and Winesburg, OH, KEP manufactures and assembles thermoplastic elastomer tubing, PVC tubing and profiles, natural rubber latex tubing, and custom dip molded parts for medical products. Our facilities already had in place quality systems tailored to comply with ISO 9001:2015, a set of guidelines that are applicable across all industries. Our newest ISO 13485:2016 certification is the medical industry’s equivalent.
“This ISO medical device certification fits very well into our existing passion for continual improvement, which plays a vital role in maintaining the trust of our customers to meet and exceed their expectations,” said Bob Oborn, KEP President. “We extend our gratitude to Beverly Kiglics and her team for taking charge over these past months and working hard to help our facilities achieve this certification.”