While the Clinical and Laboratory Standards Institute (CLSI) is not a regulating or accrediting agency, its standards and guidelines are frequently used for modeling Quality Management Systems in clinical laboratories, using its concepts of the Quality System Essentials (QSEs).
One of the twelve CLSI QSEs is Nonconforming Event (NCE) Management. This guideline, found in CLSI document QMS01-A4, Quality Management System: A Model for Laboratory Services, also does not use the ISO term “CAPA,” but it describes in detail the fundamental steps of a CAPA program.
