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Achieve Compliance Through CI
  • Medical Devices, Manufacturing, Healthcare
  • Open Access

Achieve Compliance Through CI

Publication:
Quality Progress
Date:
October 2007
Issue:
Volume 40 Issue 10
Pages:
pp. 28-33
Author(s):
Chow, Alan F., Bowman, Ronald, Wittenberg, Leonard C.

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 standards.

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