scope:

This guideline is intended for global use in laboratories to help determine QC procedures that are appropriate and effective for the test being performed. Developers will also find it useful for understanding laboratory QC requirements and how they will be assessed. The use of risk management is broadly applicable to all processes in the laboratory and can be used beyond the focus of QC. This guideline 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 developer and identified by the laboratory, applicable regulatory and accreditation requirements, and the individual health care and laboratory setting are considered in the development of a QCP.

This guideline supports the development of an individualized quality control plan (IQCP) under Clinical Laboratory Improvement Amendments requirements¹ and provides guidance for implementing risk management. This guideline might not satisfy the requirements of all regulatory, accreditation, or certification organizations. Laboratories need to comply with all applicable requirements when developing QCPs.