scope:

This guideline specifies recommendations for conducting performance qualification (PQ), routine function checks, calibration verification, and preventive maintenance (PM) of 20 types of general laboratory equipment. Installation qualification (IQ) and operational qualification (OQ) are typically completed by the manufacturer's technical service engineer and are not covered in this guideline. The records showing that IQ and OQ have been completed successfully need to be kept with the equipment documentation as described in CLSI document QMS13.⁵

Recommendations in this guideline may supplement but do not replace the equipment manufacturer's recommendations. This guideline describes a quality assurance program for equipment that evaluates performance and stresses PM. This guideline is applicable to medical laboratories of any size, complexity, or specialty and can be used by other types of laboratories, such as public health, research, food, environmental, and veterinary.

This guideline does not include information on equipment and instrumentation exclusive to an individual laboratory section, such as anatomic pathology, chemistry, or hematology. Rather, the focus is on general laboratory equipment, devices common to most laboratories regardless of specialty (eg, centrifuge, fume hood, pipette).

The suggested activities follow the equipment's lifespan. As mentioned, IQ and OQ are not described in this guideline. However, some important equipment-specific considerations for selection, installation, and safety are discussed.

⁵ CLSI. Quality Management System: Equipment; Approved Guideline. CLSI document QMS13-A. Wayne, PA: Clinical and Laboratory Standards Institute; 2011.