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ODP Earns Quality System

and CE Certification

June 1, 2004 – Orthodontic Design and Production, Inc. recently announced that its quality management system has been certified to the ISO 9001:2000 and ISO 13485:2003 international quality system standards by the prestigious British Standards Institution (BSI), and that its products have been authorized to carry the European CE Marking of conformity.

“Our CE certified products are manufactured under a quality management system that is compliant with the ISO 9001:2000 and ISO 13485:2003 international quality system standards, as well as the FDA’s CFR 820,” said Richard Merrell, ODP’s regulatory affairs manager. “Having a registered quality management system gives our customers the assurance that they will receive products that are of consistently high quality, with increased assurances that their individual needs and expectations will be met.”

ISO 9000 is rapidly becoming the world’s most important quality standard. Thousands of companies in more than 100 countries have adopted ISO standards, and many more are in the process of doing so. Adherence is accomplished through an application process for ISO 9000 certification in company standards for inspecting production processes, updating records, maintaining equipment, training employees and handling customer relations. The governing international consortium is recognized worldwide.

CE marking is a mandatory conformity mark on many products placed on the single market in the European Economic Area (EEA). By affixing the CE marking to its products, ODP asserts that the products meet all the essential requirements of applicable EU directives, and that applicable conformity assessment procedures have been applied.

Founded in 1993, Orthodontic Design and Production, Inc. offers a full range of orthodontic appliances and accessories, and is quickly emerging as a leader in the field of orthodontic design and manufacturing by offering quality products at competitive prices.