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Quality audit
From Wikipedia, the free encyclopedia
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.
The U.S. Food and Drug Administration requires quality auditing to be done as part of its Quality System Regulation (QSR) for medical devices, title 21 of the United States Code of Federal Regulations part 820. [1]
The process of a Quality Audit can be managed using software tools, often Web-based.
Internal Quality auditing is an important element in ISO's quality system standard, ISO 9001. [2]. With the upgrade of the ISO9000 series of standards from the 1994 to 2000 series, the focus of audits has shifted from procedural adherence only to measurement of the effectiveness of the Quality Management System processes to deliver in accordance with planned results.
Higher education quality audit is an approach adopted by several countries, including New Zealand, Australia, Sweden, Finland Norway and the USA [3] It was initiated in the UK and is a term designed to focus on procedures rather than quality.