UKAS
Introduction to the UKAS ISO 15189:2022 transition
UKAS
Introduction to the UKAS ISO 15189:2022 transition
9am – 9.30am BST, 26 September 2023 ‐ 30 mins
UKAS
Abstract
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.
Speakers
Using accreditation to support the validity of test results: pre-examination requirements of ISO 15189:2022
UKAS
Using accreditation to support the validity of test results: pre-examination requirements of ISO 15189:2022
9.30am – 10am BST, 26 September 2023 ‐ 30 mins
UKAS
Speakers
Using accreditation to support the validity of test results: validation and verification requirements of ISO 15189:2022
UKAS
Using accreditation to support the validity of test results: validation and verification requirements of ISO 15189:2022
10.30am – 11am BST, 26 September 2023 ‐ 30 mins
UKAS
Abstract
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.
Speakers
Pathology Network Accreditation
UKAS
Pathology Network Accreditation
11am – 11.30am BST, 26 September 2023 ‐ 30 mins
UKAS
Abstract
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.
Speakers
ISO 15189:2022 and the impact upon delivery and maintenance of effective quality management within Point of Care Testing
UKAS
ISO 15189:2022 and the impact upon delivery and maintenance of effective quality management within Point of Care Testing
11.30am – 12pm BST, 26 September 2023 ‐ 30 mins
UKAS
Abstract
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.