The audit scope describes the extent and the boundaries of the audit in terms of:
a) the subject medical devices controlled by the quality system to be audited;
b) the quality system requirements against which the quality system is to be audited;
c) the type of audit required (initial, surveillance or special);
d) physical location of activities and documentation to be audited.
Audits for regulatory purposes should not impose an increase in the scope of quality system requirements over and above those necessary to meet regulatory requirements