Auditing of clinical laboratories is a recognized component of quality assurance practice. National regulatory standards, such as the U.S. Clinical Laboratory Improvement Amendments (CLIA), and international voluntary standards, such as those promulgated by the International Organization for Standardization (ISO), are used in the auditing. Professional organizations have long recognized the benefit of on-site, peer review. However, recent events in the U.S. question the validity of current auditing practices. To be effective, auditing must be part of a continuous quality improvement system and a key component of laboratory leadership.
