2.2 Ensuring equipment and reagents meet required standards

Equipment and reagents should be suitable for the role intended.

Equipment needs to be installed, maintained and serviced to keep it in good working order as required by the manufacturer, to ensure that it is safe and that the results or data produced are reliable. An important aspect of quality assurance is the qualification of laboratory equipment, which involves:

• installation qualification (IQ) – delivered and stored as per the design, and installed in an appropriate environment
• operational qualification (OQ) – a collection of activities to ensure that the equipment is functioning as per its specifications once installed
• performance qualification (PQ) – a collection of performance checks that demonstrate the equipment is consistently functioning as per the specifications.

Good Laboratory Practice (GLP) provides guidance on equipment design, calibration, and maintenance (WHO, 2020), whilst ISO/IEC 17025 from the International Standards Organisation provides a benchmark standard for laboratories to ‘demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world’ (ISO, 2020).

Appropriate reagents and chemicals are fundamental to accurate, precise and reliable testing in laboratories. There are several important aspects to consider with the purchase, handling, standardisation and storage of reagents and chemicals:

• Purchase of the appropriate grade of reagent from a trustworthy manufacturer, ensuring all regulatory and compliance requirements have been met.
• Storage in appropriate containers and location, with supplier and expiry date clearly marked; stored at the correct temperature as recommended by the manufacturer.
• Use of premeasured aliquots, gloves, sterile pipette tips, etc. can minimise contamination of the source reagent. Dilute as per the manufacturer’s instructions, e.g. distilled water.
• Safety – educate all users on hazards, emergency procedures, COSHH regulations, labelling with hazards, etc.

Regular quality control testing needs to be carried out to validate the accuracy and precision of the reagents.