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Overview

Medical Metrics Inc. (MMI), had an existing quality management system structured to meet FDA regulations, but it was missing a framework to help drive organization-wide improvement. MMI worked with an external consultant to create an integrated management system—a fusion of regulatory requirements with the ISO 9001 framework—and received certification to the standard in less than seven months.June 2012

http://www.asq.org/2012/06/iso-9000/quality-beyond-regulatory-requirements.pdf

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