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CFI Medical Solutions Earns ISO 13485 Certification

Posted 12/3/2007 in General by Krista Weaver

ISO 13485 is the international quality management standard for designers and manufacturers of medical devices and related services, and is in keeping with the FDA's good manufacturing practices. CFI has actively pursued this certification as part of an ongoing commitment to achieve compliance with regulatory requirements in response to the needs of the medical community at a global level.

Today, CFI was officially awarded the certification after an audit by The British Standards Institute (BSI) in early November. BSI acted as a third party registrar for the general audit and certification was awarded in recognition of CFI’s compliance with quality process standards and effective quality management systems in the design and manufacture of medical supplies.

Conformance to ISO 13485 quality assurance standards required implementing procedural changes, training, increased documentation, and adjustments to operating systems on every level of the manufacturing process at CFI’s two Fenton, Michigan facilities. "Our success in achieving this goal is because of the tremendous dedication and teamwork of everyone in the company," says CEO Dick Weaver. "ISO registration supports our pursuit of continuous improvement and our on-going commitment to provide our customers the high-quality products expected in the medical industry."

CFI was also recently nominated for Small Business of the Year, an award given by the Michigan Economic Development Council. Winners are announced April 24, 2008.

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