CLSI QMS23
General Laboratory Equipment Performance Qualification, Use, and Maintenance
CLSI QMS23-Ed2 offers guidance and recommendations to assist laboratories in proper planning, record keeping and monitoring performance qualification, function checks, calibration verification, and preventive maintenance activities for general laboratory equipment. This guideline aims to give thorough insight and enhance comprehension through provided examples.
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{{FormatPrice(nonMemberPrice)}} List PriceClinical and Laboratory Standards Institute guideline QMS23—General Laboratory Equipment Performance Qualification, Use, and Maintenance provides recommendations for conducting the initial performance qualification as well as the ongoing verification and preventive maintenance of general laboratory equipment that is essential to ensuring the achievement of accurate and reproducible examination results.
This guideline replaces the previous edition of the approved guideline, GP31-A, published in 2009. Several changes were made in this edition, including:
• General laboratory equipment is the focus, and specialized laboratory instrumentation is not included.
• Instrument implementation and manufacturer relationships are not discussed.
• PQ is discussed more extensively, and guidance for writing a PQ protocol and examples of the supporting verification forms are provided.
• Safety and environmental sustainability considerations are provided for each equipment type.
• Numerous sample forms and templates that may be modified to reflect the laboratory’s needs are included in the appendixes.
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.
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 (e.g., 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.
Clinical and Laboratory Standards Institute guideline QMS23—General Laboratory Equipment Performance Qualification, Use, and Maintenance provides recommendations for conducting the initial performance qualification as well as the ongoing verification and preventive maintenance of general laboratory equipment that is essential to ensuring the achievement of accurate and reproducible examination results.
This guideline replaces the previous edition of the approved guideline, GP31-A, published in 2009. Several changes were made in this edition, including:
• General laboratory equipment is the focus, and specialized laboratory instrumentation is not included.
• Instrument implementation and manufacturer relationships are not discussed.
• PQ is discussed more extensively, and guidance for writing a PQ protocol and examples of the supporting verification forms are provided.
• Safety and environmental sustainability considerations are provided for each equipment type.
• Numerous sample forms and templates that may be modified to reflect the laboratory’s needs are included in the appendixes.
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.
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 (e.g., 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.