This document defines an audit as a systematic and documented process for obtaining evidence and evaluating it objectively to determine if criteria are fulfilled. It states that the objectives of a quality audit are to determine conformity and nonconformity, effectiveness of quality systems, improve quality, meet regulatory requirements, and create a register of auditing organizations and quality systems. The components of an audit discussed are risk assessment, scope statement, audit program, audit procedure, and work papers. It also defines a management audit and provides references.