Download the Donnelly ISO 13485:2003 Certified Quality Management System PDF

“WE RECOGNIZE THE INDIVIDUAL NEEDS OF EACH CUSTOMERAND THE MARKETS THEY OPERATE IN”

Donnelly is committed to growth and providing exceptional service and value to the medical sector as seen in our attainment of ISO13485:2003 Medical Device Quality certification in July 2007.

As the medical sector continues to be a strong market, this certification demonstrates our commitment to our medical customers and their success. Being the leader in short-run injection molding, it is important that we give medical device manufacturers a place to go that is compliant to their unique specifications and can best serve their short-run molding needs.

ISO 13485:2003 is recognized as the worldwide benchmark for high quality medical device manufacturing and takes our ISO9001:2000 to the next level, focusing on five additional areas of process superiority: patient safety, customer complaint handling, corrective actions, affects of rework and process validation.

The process of becoming ISO13485 compliant has not only better prepared us for a growing medical customer base but it has improved our Quality Management System for all customers.