ISO 17025, ISO 15189 and ISO 22870 accreditation for Lord’s Pharmacy
Lord’s Pharmacy in central London first approached us to help with some of the difficult documentation requirements needed to pass the Stage 3 UKAS assessment for Covid swab sampling. Having made considerable progress on technical competence and SOPs, they realised they needed some help with the management procedures and overall design and presentation of the quality management system (QMS).
In an intensive 5-day assignment we worked closely with the pharmacy to upgrade and create the necessary documents, including a customised QFactorial Leadership Toolkit with which the pharmacy took ownership of the QMS during and beyond accreditation. We carried out the first internal audit and were pleased to contribute to the pharmacy’s successful ISO 17025 accreditation. Subsequently, a second member of our specialist laboratory/covid team was called in to support an extension to scope, providing additional documents for rapid antigen lateral flow testing in accordance with ISO 15189 and ISO 22870 for point of care testing (POCT).
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UKAS accreditation scopes
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ISO standards
QFactorial Service offering
Implementation
This was a typical example of a rapid, remote consultancy engagement consisting of documentation, tools, advice and auditing. The spacing between the initial accreditation and the scope extension provided an opportunity for QFactorial to demonstrate flexibility and strength in-depth, with a seamless handover between two consultants.
Applying laboratory standards to retail operations is not easy. As consultants, we always look for the pragmatic path, aiming to recognise business practicalities whilst also meeting the onerous requirements for the ISO standards, in this case ISO 17025 and ISO 15189.
UKAS accreditation was successfully achieved for covid swab sampling and rapid antigen lateral flow testing.
Q! Feedback
“Thank you…your input really helped us to achieve the accreditation”.
