TIDI Products, LLC, has announced that its Quality Management System has been recertified to ISO 9001:2000 and upgraded to ISO 13485:2003 standards. TIDI Products received its approval from TUV Rheinland of North America.
"By meeting these standards, our customers can be confident we have the
necessary systems in place to provide world-class quality and service to
meet their needs," said Kevin McNamara, president of TIDI Products.
"We also recognize that as a medical device manufacturer and supplier, the bar is set higher for us. This is why we have such a strong company-wide commitment to continuous improvement in all areas of our business. And that makes it possible for us to maintain the highest quality standards in our products and services."
ISO 9000 is a series of international quality standards developed by ISO,
the International Organization for Standardization, a worldwide federation
of national standards adopted by 145 countries.
The voluntary standards focus on the prevention of product defects through conformance to best practices at every stage of a business's process, from product design to customer service. The ISO 9001 requirements are the most comprehensive set of standards within the series, covering 20 elements of business practice.
ISO 13485 is the ISO 9000 for medical device manufacturers. This
international standard specifies requirements for a quality management
system where an organization needs to demonstrate its ability to provide
medical devices and related services that consistently meet customer and
regulatory requirements applicable to medical devices and related services.
In addition to its ISO certifications, the TIDI Products facility is
registered with the U.S. Food and Drug Administration. Its products also
comply with the essential requirements of the relevant European health,
safety and environmental protection legislations, which allow it to maintain
CE Marking.
