Imaging Core Lab Takes Quality Beyond Regulatory Requirements With ISO 9001

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

Access this article
You will need Adobe Reader to view this PDF document. Download the free Reader from Adobe
Please register to access this article

Featured advertisers

Article
Rating

(0) Member Reviews

Featured advertisers





ASQ is a global community of people passionate about quality, who use the tools, their ideas and expertise to make our world work better. ASQ: The Global Voice of Quality.