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Case Study
  • Medical Devices

Imaging Core Lab Takes Quality Beyond Regulatory Requirements With ISO 9001

Publication:
ASQ.ORG
Date:
June 2012
Author(s):
Schmidt, Megan
Organization(s):
ASQ

Abstract

Medical Metrics Inc. (MMI), had an existing quality management system structured to meet FDAregulations, but it was missing a framework tohelp drive organizationwide improvement.MMI worked with an external consultant to createan integrated management system—a fusion of regulatory requirements with the ISO 9001 framework—and receivedcertification to the standard in less than seven months.MMI continues to make its quality managementsystem stronger after passing the audit.Though MMI’s certification is recent, it is alreadyseeing improvements to the timeliness of deliverables toclinical trial sponsors. MMI also reports an increase inquality awareness from the ISO 9001 implementationand has received positive feedback from sponsors.

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