Press Release: NEW ISO Certification

Effective May 22nd, 2024, ICON Injection Molding is now certified to ISO 13485.

We will retain our existing ISO 9001:2015 certification (which was also successfully renewed in May 2024) but now also hold the higher-level ISO 13485 certification.

Though ISO 13485 is intended to apply to medical devices, the documentation, controls, and procedures required for this certification are implemented company-wide, on all customer products, regardless of industry, purpose, or end user. ICON has operated “13485 compliant” for many years but this year our team decided to undertake the necessary auditing to officially certify our company to ISO 13485 standards. This required a comprehensive update to our QMS (Quality Management System) and the value-added to customers will be seen through enhanced efficiency, improved productivity, and a stronger quality team. While we have always been a “quality first” company, taking a holistic approach to quality control/quality assurance and believing that our mission of Excellence from Art to Part drives continual improvement and quality product offerings to our customers, the ISO 13485 requirements now hold us to a higher standard of quality and risk-management woven throughout all departments and organizational levels.

We would like to give a special shout-out to our Quality Director, Ken Wolf, for his monumental efforts in spearheading this effort in a highly limited timeframe, and to the rest of the Quality Department for their contributions to this project!

If you are a current customer and would like a copy of our new ISO 13485 certification for your supplier records, please email us at compliance@iconinjection.com.