TIDI Products, LLC announced today 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,² said Kevin McNamara, president of TIDI Products. ³We 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.²
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 business¹s 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.
TIDI Products is a leading manufacturer of single-use patient-care products for the medical and dental industries. Its products include patient exam gowns, examination table paper, dental bibs, gauze sponges and thermometer sheaths. TIDI Products customers include numerous leading healthcare and dental product distributors.