Certification represents Kent’s commitment to manufacturing quality medical devices
LOVELAND, Colo.—Kent Systems, a designer and manufacturer of plastic fluid-management components, recently announced that it 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’s 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 that its quality management systems continue to improve, the company said in a press release.
“Achieving ISO 13485 cements our commitment to quality management,” said Erinn Mitchell, operations manager at Colorado-based Kent systems, in the release. “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.
Kent Systems (www.kentsystems.com) is dedicated to designing, manufacturing, and distributing quality Quick Couplings, Tube Fittings, Medical Luers, and Media Bags to provide a complete system for fluid transfer needs. Founded in 2001 and owned by Lyle and Linda Sampson, Kent Systems believes in helping customers get more from their fluid systems while keeping all production in the USA, manufacturing in its Class 7 Cleanroom in Loveland, Colorado.