BS EN ISO 15189 – Quality Management in Laboratories webinar

Get to know the revised standard for quality and competence in medical laboratories

Recorded: 18 October 2022

Timing: 10.30 am – 11.30 am (BST)

What’s the webinar on quality and competence in medical laboratories about?

BS EN ISO 15189:2022 Medical laboratories. Requirements for quality and competence is the updated international standard on requirements for quality and competence in medical laboratories. This webinar will break down the key changes to help pathology services prepare for their transition to the new version when it is published.

Who should attend?

• UK diagnostic pathology services
• Suppliers of invitro diagnostic equipment for pathology laboratories
• Healthcare facilities
• Regulating authorities
• Accreditation bodies

What will participants gain?

• Authoritative guidance on the changes to be made to the international standard
• Help with transitioning to the new standard
• The chance to put your questions on the new standard to subject experts
• A post-event copy of all presentations and a recording of the webinar

AGENDA

10:30 Introductions

10:35- 10:55 The main clauses of the standard – Dr David Ricketts

10:55- 11:15 Overview of management and technical requirements, including point-of-care testing – Ben Courtney

11:15-11:25 Questions

11:25-11:30 Summary and next steps

David currently works as head of process improvement for Health Service Laboratories in central London, which is part of the wider Sonic Healthcare group and is the managing director of his own Consultancy firm, in which capacity he is speaking today.

David chairs the UK mirror committee to ISO/TC 212 and is head of delegation for the UK on the international ISO/TC 212 committee. David has experience in writing standards and was the project lead on ISO 22870, on the drafting team of the new ISO 15189, as well as being involved in many other standards including ISO 22367. David has written many expert commentaries for British Standards. The commentaries are designed to explain the changes in new version of ISO standards and explain how to use them in the laboratory setting, ISO 22367 and ISO 15190 (safety) are two recent commentaries.

David has a strong background in laboratory process improvement and links this to the needs of compliance with ISO requirements.

David has spoken nationally and internationally on a wide range of subjects including quality and compliance and is speaking on risk and safety as well as the new version of ISO 15189 at the IBMS conference this year in Birmingham. The IBMS is the Institute of Biomedical Science, the professional body for most laboratorians in the UK.

Helena Barrell joined BSI as a Standards Development Manager in 2019. She manages a range of UK standards committees, which include CH/212 IVDs, CH/150 Implants for surgery and CH/338 Menstrual products. Prior to working at BSI, Helena gained experience in publishing, with editorial roles at a professional membership body and in the charity sector.

Ben started as a Biomedical Scientist in Microbiology and worked in the NHS for 10 years before joining the United Kingdom Accreditation Service (UKAS) as Assessment Manager.  Ben assessed a broad scope of organisations – medical laboratories (all disciplines), testing laboratories, proficiency testing providers and point of care testing providers.  

After four years, Ben was appointed Section Head for Medical Laboratories and oversaw the transition of pathology laboratories from CPA accreditation to accreditation by UKAS to ISO 15189:2012.  In his time as Section Head, Ben’s portfolio of responsibility was extended to include the introduction of Physiological Sciences accreditation and Imaging accreditation.

In the last two years with UKAS, Ben worked closely with the Department of Health and Social Care (DHSC) and UKHSA in providing minimum standards for private providers of COVID-19 testing and subsequently managed the unprecedented growth at UKAS.  This involved interpreting and applying ISO 15189:2012 for brand new applicants for accreditation and devising novel approaches of recognising them.

Ben is currently Clinical and Quality Director at Cignpost Diagnostics responsible for providing clinical oversight of product evaluation, training and public health authority data reporting as well as responsibility for the implementation of ISO 15189 and regular quality improvement.

Ben is Deputy Chair of CH 212 and is a member of the international ISO TC 212 and Working Group 1 which has been redrafting  ISO 15189 (Medical Laboratories - Requirements for quality and competence) and the incorporation of ISO 22870 (Point of care testing – Requirements for quality and competence).