The ISO 13485 standard represents a manufacturer’s commitment to quality systems, and was developed to support manufacturers of medical devices, per KENT.
KENT Systems said it 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 Operations Manager Erinn Mitchell. “After our transition to the updated ISO 9001:2015 last month, we’re 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.
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