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. The
new inspectional process is known as the
“Quality System Inspection Technique” or
“QSIT”. Field investigators may conduct an efficient
and effective comprehensive inspection
using this guidance material which will help
them focus on key elements of a firm’s quality
system.