2 Ensuring quality in the laboratory

What is ‘quality’?

There are many notions associated with the term ‘quality’. For an organisation, quality is associated not only with the products and services it produces to satisfy a demand, but also the processes in place to generate these products or services. In a biomedical laboratory, several factors can affect the final report – the competency of the technician, the laboratory procedure, the reagents used in the assay, the equipment and the facilities. In Figure 1, these and other factors are grouped into 12 quality systems essentials (QSEs) covering organisation and management, process control, and continuous improvement – a cornerstone of any quality management system (QMS) (WHO 2011a). You will learn about QMSs in Section 3.3.

Figure 1 The 12 quality systems essentials that are a critical requirement for a laboratory’s quality management system. Note that ‘process control’ covers all laboratory activities of the laboratory workflow.

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Twelve circles labelled ‘Organisation’, ‘Personnel’, ‘Equipment’, ‘Purchasing and inventory’, ‘Process control’, ‘Information management’, ‘Documents and records’, ‘Occurrence management’, ‘Assessment’, ‘Process improvement’, ‘Customer service’, and ‘Facilities and safety’.

Figure 1 The 12 quality systems essentials that are a critical requirement for a laboratory’s quality management system. Note that ...

The principles of ensuring high-quality data include:

• ensuring that the laboratory, its equipment and reagents meet the standards needed to ensure biosafety and biosecurity, and allow the production of quality results
• establishing procedures at all test stages to minimise errors and ensure results are reproducible and reliable
• measuring performance against international standards
• monitoring and improving practice.

Information must also be recorded and reported accurately. If the laboratory generates a reliable, accurate result but the wrong information is entered into the report, all the hard work done to get the result is wasted.