ISO Quality Management Certifications

Red Eagle Stainless ISO 9001 stamp

Eagle Stainless Tube & Fabrication Inc. proudly renewed ISO 13485 and ISO 9001 quality management certifications, reaffirming its unwavering dedication to Quality and Compliance.

Franklin MA, July 2023 – Eagle Stainless Tube & Fabrication, a leading small-diameter stainless steel tubing supplier, is proud to announce the successful renewal of its ISO 13485:2016 and ISO 9001:2015 quality management certifications. Eagle has been maintaining ISO quality certifications since 1998, spanning 25 years! This achievement reflects the company’s unwavering commitment to maintaining the highest standards in quality management systems for medical devices and related services.

ISO 13485 and ISO 9001 are internationally recognized standards that set requirements for the development, production, and distribution of medical devices. By adhering to this rigorous specification, Eagle Stainless ensures that its products and services consistently meet our customer’s stringent requirements. To obtain the renewed ISO certifications, Eagle Stainless Tube underwent a comprehensive evaluation process, including an extensive audit conducted by an independent certification body. The assessment covered various aspects of the company’s operations, including quality management, risk management, documentation controls, and product traceability.

“We are thrilled to have again successfully renewed our ISO certifications,” said Robert J Bubencik Jr. VP of Operations “This accomplishment reinforces our commitment to excellence, continuous improvement, and meeting the evolving needs of our customers and partners in the medical device industry. It also validates our dedication to providing safe, effective, and reliable products that contribute to the overall well-being of patients worldwide”

ISO 13485 certification demonstrates Eagle Stainless Tube’s ability to consistently provide medical devices and services that meet our customer requirements and expectations. It further highlights the organization’s commitment to ongoing quality assurance, adherence to industry best practices and maintaining a culture of excellence. This renewed certification serves as a testament to the company’s commitment to quality, compliance, and customer satisfaction.

For more information about Eagle Stainless and our quality management certifications, please contact us today!