ABSTRACT

Quality audits are considered as an essential part of a quality assurance program. Audits are of two types: systems audits describe those conducted to qualitatively evaluate the operational details of a Quality Assurance program, while performance audits are conducted to quantitatively evaluate the outputs of a measurement system. The frequency and criticality of internal audits will depend on the critical nature of the data outputs, on the threat or risk associated with erroneous or questionable results, and on the pride of workmanship of management and staff. An internal performance audit consists essentially of reviewing the ongoing quality assessment program of a laboratory. External auditors ordinarily want to see the records of internal audits, especially if they are required in a mandatory quality assurance program. Well-maintained records can inspire the confidence of external auditors as well as facilitate and increase the effectiveness of external audits.