Achieve Compliance Through CI

Abstract:Using Six Sigma tools for continuous improvement (CI) is a proven method for meeting or exceeding FDA requirements for medical devices. Optical Integrity Inc., a manufacturer of medical devices, used the Six Sigma define, measure, analyze, improve and control (DMAIC) process to comply with the FDA’s concept of current good manufacturing practice (cGMP) and ISO 9001 requirements. The manufacturer’s achievement demonstrates the synergy that can exist between CI and cGMP requirements. Adopting a Six Sigma philosophy provides a compliant quality management system and a means for meeting both the regulatory requirements and international quality …

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Great article with clear and straight-forward concepts!!
--Cristina, 04-06-2010


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