A Quality Audit is the process of systematic examination of a quality system carried out by an internal or external quality auditor or an audit team.
MitoPedia concepts: MitoFit Quality Control System
It is an important part of organization's quality management system and is a key element in the ISO quality system standard, ISO 9001.
Audits are an essential management tool to be used for verifying objective evidence of processes, to assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined target levels, to provide evidence concerning reduction and elimination of problem areas. For the benefit of the organisation, quality auditing should not only report non-conformances and corrective actions, but also highlight areas of good practice. In this way other departments may share information and amend their working practices as a result, also contributing to continual improvement.
Quality audits can be an integral part of compliance or regulatory requirements. One example is the US Food and Drug Administration, which requires quality auditing to be performed as part of its Quality System Regulation (QSR) for medical devices.