» Deadline Extension for Transition to ISO 15189

29 March, 2018

Since 2013, UKAS has been undertaking assessments to enable CPA accredited medical laboratories to transition their accreditation to ISO 15189:2012.  This transition has progressed well and has resulted in many improvements to medical laboratory services; it has also presented challenges to laboratories and also to UKAS. 

During the past 12 months we have experienced an increased demand for the remaining transition assessments (whether that be Initial Assessments or Extra Assessments). This volume of work has posed challenges to meeting our expected performance measures and we are aware that there have been some delays experienced.  As a consequence of this, and recognising that it is important that all laboratories yet to be accredited have a fair and reasonable time to address any findings arising from the assessments, the decision has been made to postpone the withdrawal of CPA Standards to the end of September 2018. This will ensure that accreditation can be maintained over this remaining period of the transition.

It is still expected that laboratories continue to meet specified deadlines with regards to submission of evidence as quoted in the Assessment Report (AR) and Improvement Action Report (IAR) from the assessment.  Where satisfactory evidence is submitted as per the AR, IAR and any associated further evidence request letters that clears the finding raised, there will be no risk to on-going CPA accreditation between now and September 2018, as long as there are no additional changes to the service since the last assessment.  CPA accreditation will only be withdrawn in that period once ISO 15189:2012 accreditation is granted.  Should deadlines for submission of evidence not be met or if evidence submitted repeatedly does not satisfactorily address the finding(s), consideration will be given to sanctions as per current CPA procedures.  Where findings are not satisfactorily addressed by the end of September 2018, CPA accreditation will be withdrawn in line with the withdrawal of CPA Standards for Medical Laboratories.