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. [From §820.3(t)
A test of an institution's quality assurance and control system through a self-evaluation and external review of its programs, staff, and infrastructure. Designed to provide an assessment of an institution's system of accountability, internal review mechanisms, and effectiveness with an external body confirming that the institution's quality assurance process complies with accepted standards.
a documented activity aimed at verifying, by independent examination & evaluation, that the applicable elements of the quality assurance program have been established, documented and implemented effectively in accordance with specified requirements.
A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives.
A systematic examination of the acts and decisions, with respect to quality, in order to independently verify or evaluate the operational requirements of the quality program or the specification or contract requirements of the product or service.
Quality audit means a systematic, independent examination of a quality system. Quality audits are typically performed at defined intervals and ensures that the institution 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.
a structured review of other quality management activities, with the objective to identify lessons learned that can improve performance of this project or other projects within the performing organization