KENT Systems earns ISO 13485 Certification for quality management
KENT Systems’ continued quest for operational excellence reached another milestone, as the Colorado-based designer and manufacturer of plastic fluid-management components achieved ISO 13485 certification
The ISO 13485 standard represents a manufacturer’s commitment to quality systems and was developed to support manufacturers of medical devices.
It is the most up-to-date international standard for quality management systems.
KENT Systems will use the latest certification in concert with the recent addition of ISO 9001:2015 to ensure its quality management systems continue to improve and remain on the industry’s leading edge.
“Achieving ISO 13485 cements our commitment to quality management,” said Erinn Mitchell, KENT Systems Operations Manager.
“After our transition to the updated ISO 9001:2015 last month, we are happy to incorporate another quality standard into our constantly evolving manufacturing process.”
The ISO 13485 standard was developed to guarantee that quality systems ensure consistency for manufacturers of medical devices.
Controls include risk management and design controls, traceability and documentation, and validation for sterile devices.