DONNELLY’S COMMITMENT TO MEDICAL MOLDING GROWS WITH ISO 13485 CERTIFICATION

ALEXANDRIA, Minn. – DDonnelly Custom Manufacturing Company announces the attainment of its ISO13485:2003 Medical Device Quality certification. This certification reflects Donnelly’s commitment to growth and providing exceptional service and value to the medical sector.

“The medical sector continues to be a strong market and not all molders can have a hand in the game,” said Ron Kirscht, president of Donnelly. “This certification demonstrates our commitment to our medical customers and their success. Being the leader in short-run injection molding, it is important to 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 Donnelly’s ISO9001:2000 to the next level, focusing on five additional areas of process superiority. Patient safety is the most critical of these and the associated risk management is addressed during the product launch process.

Other differences include the additional documentation, root cause analysis and corrective actions required for customer complaint handling. With ISO 13485:2003, the potential adverse affects of rework is more heavily analyzed and finally, process validation is enhanced because injection molding is considered a special process and cannot be validated by part inspection alone.

“The process of becoming ISO13485 compliant has not only better prepared us for a growing medical customer base,” said Sam Wagner, director of advanced manufacturing at Donnelly. “But it has improved our Quality Management System for all of our customers.”

Based in Alexandria, Minn., Donnelly’s 230 employees are dedicated to setting the standards in the custom injection-molding marketplace for “How Short Run Is Done.” The company’s focus is on providing its OEM customers with value added engineering, and highly customized manufacturing and customer support services.  A strong customer service orientation ensures outstanding customer satisfaction.