Quality audit

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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 ^[1]. It is an important part of organization's quality management system and is a key element in the ISO quality system standard, ISO 9001.

Quality audits are typically performed at predefined time intervals and ensure that the institution has clearly-defined internal quality monitoring procedures linked to effective action. This can help determine if the organization complies with the defined quality system processes and can involve procedural or results-based assessment criteria.

With the upgrade of the ISO9000 series of standards from the 1994 to 2000 series, the focus of the audits has shifted from purely procedural adherence towards measurement of the actual effectiveness of the Quality Management System (QMS) and the results that have been achieved through the implementation of a QMS.

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 (Title 21 of the US Code of Federal Regulations part 820^[2]).

Several countries have adopted quality audits in their higher education system (New Zealand, Australia, Sweden, Finland, Norway and USA) ^[3] Initiated in the UK, the process of quality audit in the education system focused primarily on procedural issues rather than on the results or the efficiency of a quality system implementation.

Audits can also be used for safety purposes. Evans & Parker (2008) describe auditing as one of the most powerful safety monitoring techniques and 'an effective way to avoid complacency and highlight slowly deteriorating conditions', especially when the auditing focuses not just on compliance but effectiveness. ^[4]

The processes and tasks that a quality audit involves can be managed using a wide variety of software tools.