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Audit

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Definition

A Quality audit is a systematic examination of a quality system. Quality audits are typically performed at defined intervals and ensures that the organization has clearly-defined internal quality monitoring procedures linked to effective action. The checking determines if the quality system complies with applicable regulations or standards The process involves assessing the standard operating procedures (SOP's) for compliance to the regulations, and also assessing the actual process and results against what is stated in the SOP.

Quality audits can be further defined by who performs the audit:

A First-Party Audit is carried out by the organization itself. In other words, it is a self-assessment or internal audit. These can be performed by sub-contractors, but no external certification is given or expected.

A Second-Party Audit is carried out by a customer of the organization.

A Third-Party Audit is performed by a body that is independent of both the organization and customer. An example is ISO 9000 certification where an organization's quality management system is assessed by an independent certification or registration body against the requirements of an ISO 9000 standard.

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