FDA Guide to Inspections of Quality Systems
Title:
FDA Guide to Inspections of Quality Systems
Origin/Publisher:
FDA http://www.fda.gov/ora/inspect_ref/igs/qsit/QSITGUIDE.PDF
Content:
This document provides guidance to the FDA
field staff on a new inspectional process that
may be used to assess a medical device
manufacturer’s compliance with the Quality
System Regulation and related regulations.