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A service that simplifies ISO15189 compliance and UKAS inspections

An introduction to a ground-breaking toolkit now available that aims to ease the burden of the many standards with which laboratories must comply, and reduce the stress associated with the regular accreditation visits

If you ask a laboratory manager about ISO15189:2012 and inspections by the United Kingdom Accreditation Service (UKAS), the response may be guarded. Improving the quality of patient care is paramount for NHS pathologists – yet even the most efficient laboratory will say that meeting the standard’s exacting requirements can be arduous, time-consuming and stressful.

          By comparison, if you were to ask a Stago customer running their accreditation tools on one of the STA Max generation systems (pictured), the answer might be a little different. Its software is able to pull information from the analyser and produce UKAS-ready reports for all ISO15189 requirements. This is actioned at speed, with full traceability; and offers such detail that customers consider Stago’s accreditation service a “valued ally”, taking some of the stress out of accreditation reporting, especially noticeable during the COVID crisis.

          The NHS focus on process improvement is also driven in part by the need for compliance with accreditation requirements, especially for quality assessment. This emphasises the importance of standardisation as a means of reducing controllable errors. For example, ISO15189 requires that variability is assessed when verifying an assay or when acceptance testing is carried out on a new batch of reagent. Standardising this exacting process can easily be achieved when tools to carry this out are embedded in the software. Figures 1–3 illustrate the results for repeatability, reproducibility and method comparison, respectively.

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