3.13 Quality audit means a systematic, independent examination of a manufacturer's quality system that is performed at defined intervals and at sufficient frequency to determine whether both quality system activities and the results of such activities comply with quality system procedures, that these procedures are implemented effectively, and that these procedures are suitable to achieve quality system objectives. 3.14 Quality policy means the overall intendon and direction of an organization with respect to quality, as established by management with executive responsibility. 3.15 Quality system means the organizational structure, responsibilities, procedures, processes, and resources for implementing quality management.