9am – 9.30am BST, 26 September 2023 ‐ 30 mins
This session provides an overview of the key changes to the ISO 15189 standard and explains the UKAS transition process including deadlines and actions to be taken by accredited organisations.
The same session is being run on Monday, Tuesday and Thursday to ensure as many delegates as possible are able to attend.
10.30am – 11am BST, 26 September 2023 ‐ 30 mins
The principles of validation and verification have long been established and laboratories are generally familiar with these although there remain some issues which are commonly seen within verification reports during assessments. Some of these require some further attention and discussion, including consideration of sample type, verification across multiple sites and approaches used when upgrading analysers. Alongside these common issues, ISO 15189:2022 has now been issued with assessments to become mandatory to the new standard from January 2024 and whilst the principles of validation and verification are generally unchanged, there are some differences which will require review of internal procedures and approaches to verification. Awareness of these changes will form a part of the presentation, along with issues commonly seen, being hoped these will promote some thought as to how laboratories can consider the local approaches used.
11am – 11.30am BST, 26 September 2023 ‐ 30 mins
Pathology services across the UK are increasingly working together as formal or informal networks, to support improved patient care.
This session provides an overview of accreditation options and considerations for pathology networks.
11.30am – 12pm BST, 26 September 2023 ‐ 30 mins
ISO15189:2012 had reached its periodic review date and there was international consensus that it needed revision. The new version was published on 6th December 2022 and there are some key changes which include an emphasis on a patient-focused approach and to promote the welfare of patients - i.e. putting the patient at the heart of the service. There is also more emphasis on a risk-based approach to the Quality Management system. In addition, ISO 22870 (POCT) has been incorporated into ISO 15189:2022.
This presentation will review POCT definitions, highlight key considerations for currently accredited POCT services and also for organisations considering applying for accreditation to include (or extend) POCT in their scope.
POCT is referenced implicitly throughout ISO 15189:2022 and with additional distinct requirements as an Annex A.
The presentation will discuss generic POCT services, and highlight considerations on both current POCT services and also emphasise considerations for planning new POCT services, and that overall, when compared with ISO 22870:2016, things have not changed as much as one would think. Principles are similar, and POCT could even be considered as another specialty within pathology, regardless of where it is or managed from.
Technical Manager - Policy and Implementation, UKAS
Richard has been involved with quality management for over twenty-five years with as background that covers many chemistry disciplines from nuclear to environmental. the last 15 years have been with UKAS in a variety of roles from assessment to his current position as technical manager (policy and implementation) where management of overall technical rigour of UKAS processes is a high priority.
He is an active member of European and international committees involved the development / revision and implementation of European and international standards.
Introduction to the UKAS ISO 15189:2022 transition Tuesday @ 9:00 AM
Assessment Manager, United Kingdom Accreditation Service (UKAS)Alison is an Assessment Manager within UKAS, starting in March 2020 just before the first lockdown. She is the technical focus person for Biochemistry within Healthcare and supports the mentoring programme for trainee Assessment Managers. Prior to UKAS, Alison worked as a Biomedical Scientist in the NHS in Microbiology and a multi-disciplinary role within private healthcare.
Using accreditation to support the validity of test results: pre-examination requirements of ISO 15189:2022 Tuesday @ 9:30 AM
Assessment Manager, United Kingdom Accreditation Service (UKAS)
Mark has been with UKAS for over 10 years working as an Assessment Manager and Technical Assessor for Microbiology / Virology, also being the Technical Focus Person for these disciplines in the Medical Laboratories Section. He has significant experience of working in both NHS and private laboratory services before this.
Mark predominantly assesses against ISO 15189:2012 although also having training in assessment against standards for Point of Care testing (ISO 22870, now withdrawn), Proficiency Testing (ISO 17043) and Testing & Calibration Laboratories (ISO 17025).
Using accreditation to support the validity of test results: validation and verification requirements of ISO 15189:2022 Tuesday @ 10:30 AM
Healthcare Accreditation Specialist, UKAS
Alyson spent 15 years in NHS cellular pathology laboratories prior to moving to UKAS 7 years ago. She started at UKAS as an assessment manager for ISO 15189:2012 laboratories, during the CPA transition project.
Throughout 2020 and 2021, Alyson was heavily involved in UKAS's response to the Covid pandemic, with particular focus on the private providers of Covid-19 testing since December 2020. She is now working as the Healthcare Accreditation Specialist, providing technical oversight for the whole Healthcare section of UKAS, to ensure they remain up-to-date and responsive to their customer's needs.
Introduction to the UKAS ISO 15189:2022 transition Monday @ 4:25 PM
Pathology Network Accreditation Tuesday @ 11:00 AM
Introduction to the UKAS ISO 15189:2022 transition Thursday @ 11:10 AM
Senior Assessment Manager Healthcare , UKAS
After gaining a degree in Biochemistry and Microbiology from Leeds University, John’s first post was as a company microbiologist in a small scientific consultancy specialising in foods, waters, cosmetics and pharmaceuticals and sterile manufacture processes. His main interests however were in medical microbiology so he joined Poole PHLS and hospital microbiology laboratories, where he completed the then IBMS Special exam.
John then moved to County Durham, developed an interest in management and quality, gained qualifications in such and held senior, management then quality management posts until the end of 2005.
John joined CPA (UK) Ltd as a full time Regional Assessor in January 2006. CPA is now a wholly owned subsidiary of the United Kingdom Accreditation Service (UKAS) and since June 2013 he was an Assessment Manager (AM) with UKAS and from November 2014, promoted to Senior Assessment Manager. John manages other AMs and is active in various projects, including training in ISO 15189, POCT, transition projects, and developing training for new AMs.
During John’s professional career and in his many outside interests and activities, John has always developed his interest in teaching, training and biomedical science promotion and career development and been active in education and development of scientific and support staff. He has actively promoted pathology to a wider audience within the NHS and has been involved in both medical and nursing staff education.
John has been involved in and tutored on courses for the IBMS, been a training/portfolio assessor for the CPSM and then IBMS, panel member for the HCPC and been a lay board member for the Northern Deanery involved with post graduate medical education. John has presented at numerous local and national meetings on both scientific and management themes, and now presents regularly on quality and accreditation themes.
When not working, John has a passion for all things “planes, automobiles, motorcycles and trains”. He has a private pilot’s licence, although spiralling costs and time constraints have curtailed that pursuit for the time being. He is also planning to restore an MGF car.
ISO 15189:2022 and the impact upon delivery and maintenance of effective quality management within Point-of-Care Testing Monday @ 1:00 PM
ISO 15189:2022 and the impact upon delivery and maintenance of effective quality management within Point of Care Testing Tuesday @ 11:30 AM
The revised ISO 15189 standard and the impact upon delivery and maintenance of effective quality management within Point-of-Care Testing Thursday @ 11:30 AM