Teleflex Medical OEM Granted ISO 13485:2003 Quality Certification for Plymouth Facility

RALEIGH, N.C. Teleflex Medical OEM, a leader in interventional and diagnostic catheters, has achieved ISO 13485:2003 certification for its catheter fabrication and assembly facility located in Plymouth, Minnesota. Awarded by the International Organization for Standardization (ISO) through BSI Management Systems, this certification signifies compliance with stringent international standards in the manufacturing of medical devices.

To be certified to the standard, a company must implement a quality management system to demonstrate the ability to provide medical devices and related services that consistently meet customer and regulatory requirements. The scope of this quality management system encompasses training, production, purchasing of products, and delivery to the customer. As part of the ISO certification process, a team of auditors performed on-site assessments, verified documented procedures, and examined the overall operations at the Plymouth site.

The ISO is a worldwide network of the national standards institutes of 157 countries. While compliance with ISO standards is voluntary, they are widely accepted by both public and private sectors worldwide.

“We are very pleased to have attained this ISO certification, as it says a tremendous amount about the quality of the catheter-based products produced at the Plymouth facility and the systems we have in place to ensure standards are met,” said Quality Assurance and Regulatory Affairs Manager Joel Ericson. “This is not an easy designation to receive. I thank the entire Plymouth staff for their dedication and hard work that has made this certification possible."

The ISO certification of the Plymouth facility represents a major achievement for Teleflex Medical OEM: All of the company’s OEM facilities meet ISO requirements and are certified.

(April 2009)