ALGONQUIN, IL - Kenmode Precision Metal Stamping, a recognized leader in medical device precision metal stampings, announced that it has received ISO 13485:2003 certification.
This certification is awarded to companies that demonstrate a comprehensive management system for the design and manufacture of medical devices.
“We are proud to have completed and attained ISO 13485:2003 certification,” states Kurt Moders, Kenmode President. “This certification is a testament to Kenmode’s stringent quality systems and our commitment to our medical customers and the patients and healthcare providers who rely on the performance and safety of medical devices.”
ISO 13485:2003 is the quality management system standard specific to the medical industry. The requirements emphasize critical areas impacting design, process, quality, and manufacturing reliability for medical device products. This certification is an internationally recognized management system standard developed by the International Organization for Standardization (ISO).
“A growing number of device manufacturers are demanding that their suppliers have validated and compatible quality systems and processes”, adds Pat Kenkel, Kenmode’s Director of Quality. “Certification to ISO 13485:2003 highlights Kenmode’s ability to design and manufacture medical device components that consistently meet customer and regulatory requirements.”
With this latest quality achievement, Kenmode is now ISO 13485:2003, ISO 9001:2008 and ISO/TS 16949:2009 certified.
About Kenmode Precision Metal Stamping
Kenmode manufactures complex, high-precision custom metal stampings and assemblies for the automotive, electronics, consumer goods, insert molding, and medical device industries. Kenmode employs the latest technology available throughout the design and production process, including 3D design, robotics, in-die sensors and video inspection systems. Kenmode has the ability to handle a wide range of materials and component parts from micro miniature medical stampings to large automotive stampings.