Quality Control: A Review

Abstract

Quality control (QC) is a procedure or set of procedures intended to ensure that a manufactured product or performed service adheres to a defined set of quality criteria or meets the requirements of the client or customer. There are many guidelines for quality control, which may vary; these include CLSI, CLIA, ISO, NATA, Rili BAK, and QCI. Clinical and laboratory standard Institute (CLSI) was accredited by American national standard institute in 1977; this was made for improving comparability of test results .CLIA is Clinical Laboratory Improvement Amendments having objective to ensure accuracy, reliability and timeliness of test results performed on specimens from humans, such as blood, body fluid and tissue. Most International Organisation for standardization or ISO is a nongovernmental organisation required for quality and competence of laboratories, which is further divided into ISO 17025 for general laboratories and ISO 15189 for medical laboratories. National Association of Testing Authorities or NATA is Australia based; these authorities favour in using controls independent of those produced by the manufacturer of the test or analyser. Rili-BAK is German Medical Association on quality assurance in medical laboratory examinations. It states that control samples must be similar as possible to the patient samples. For registration of medical testing laboratories in India, Quality council of India is essential. According to QCI, medical laboratories shall perform internal quality control as well as use of third party quality control is recommended for all analytes in the lab. Therefore it can be said that quality control programme should be followed to maintain proper standard.

Keywords: CLSI, CLIA, ISO, NATA, QCI, Quality control, Rili BAK

Cite this Article

Priyanka Verma. Quality Control: A Review. Research & Reviews: Journal of Medical Science and Technology. 2020; 9(1): 38–46p.