The quality management system at Mack Molding’s Headquarters Plant (Arlington, Vt.) has been independently audited and certified to be in compliance with the requirements of the ISO 13485:2003 international quality standard for medical device manufacturing.
The International Organization for Standardization (ISO), a prestigious network of national standards institutes from 157 countries, created the standard to provide medical devices that consistently meet applicable customer and regulatory requirements. Intertek Systems Certification, an accredited registrar, carried out the third-party assessment and certification.
“Achieving this quality hallmark for medical device manufacturing has required a yearlong intensive focus on quality system analysis, creating and modifying procedures, and training personnel,” says Jeff Somple, president of Mack’s Northern Operations. “The resulting certification demonstrates that our quality system meets the internationally recognized standard for medical device manufacturing. It assures customers we are continually driving toward quality system improvement. And it represents yet another major milestone in our calculated growth as a contract manufacturer in the medical device sector, where we focus on complex medical device assemblies.”
In addition, Intertek audited and recertified Mack’s Headquarters Plant and the other Vermont facilities in Pownal, Cavendish and East Arlington as having met the ISO 9001:2000 standard, an international reference for quality requirements in business-to-business dealings. “Long ago, Mack made ISO standards the underpinning of its quality management system,” says Wanda Knowles, director of quality and information systems. “We were one of the first injection molders in the U.S. to achieve ISO certification, and have been annually measuring total customer satisfaction for over a decade now.”
Contact: Wanda Knowles, Dir., Quality & Information Systems
ISO is a non-governmental organization that has been developing voluntary technical standards over almost all sectors of business, industry and technology since 1947. www.iso.org
Intertek Systems Certification is an accredited registrar that performs third party assessment and registration of management systems against the requirements of national and international standards. Co-headquartered in Boxborough, Mass., and Lachine, Quebec, Intertek has 18 established offices located throughout the Americas, Europe, the Middle East, Africa and the Asia-Pacific region. www.intertek-sc.com