ISO 13485: Creating a Globally Harmonized Quality SystemAn overview of the standard's requirements and use around the world.
Fri, 07/17/2009 - 16:44
Through the 1990s, the application of a quality system relied primarily upon the Food and Drug Administrations’ (FDA) good manufacturing practice requirements or the FDA 21 CFR Part 820 Quality System Regulation. At that time, the international…