Case Study- June 2012
Abstract: Medical Metrics Inc. (MMI), had an existing quality management system structured to meet FDA regulations, but it was missing a framework to help drive organizationwide 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. MMI continues to make its quality management system stronger after passing the audit. Though MMI’s certification is recent, it is already seeing improvements to the timeliness of deliverables to clinical trial sponsors. MMI also reports an increase in quality awareness from the ISO 9001 implementation and has received positive feedback from sponsors.
Keywords: case study - ISO 9001 - quality management systems - external consultant - auditing - integrated management system - FDA regulations - regulatory requirements
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