scope:

This document describes good laboratory practice for developing and maintaining a quality control plan (QCP) for medical laboratory testing using internationally recognized risk management principles. An individual QCP should be established, maintained, and modified as needed for each measuring system. The QCP is based on the performance required for the intended medical application of the test results. Risk mitigation information obtained from the manufacturer and identified by the laboratory, applicable regulatory and accreditation requirements, and the individual health care and laboratory setting are considered in development of the QCP. This document is intended to guide laboratories in determining quality control (QC) procedures that are both appropriate and effective for the test being performed.

This document may not satisfy the requirements of all regulatory, accreditation, or certification bodies. Laboratories need to comply with all applicable requirements in the development of their QCPs.