What Does QSR Stand For?
QSR stands for Quality System Regulation
Quality System Regulation (QSR) refers to a set of guidelines and requirements established by regulatory agencies, particularly the U.S. Food and Drug Administration (FDA), to ensure that medical device manufacturers implement and maintain an effective quality management system. QSR outlines the necessary processes, documentation, and controls that organizations must follow to ensure their products are safe, effective, and compliant with regulatory standards throughout their lifecycle. Compliance with QSR helps improve product quality and reliability while safeguarding public health.
Added on 27th September 2008 | Last edited on 16th June 2025 | Edit Acronym