ISO 15189:2022 – A new task for medical laboratories
Contents
2022 saw the publication of a new version of ISO 15189 - Medical laboratories - Requirements for quality and competence. One of the main changes in the new version of the standard is the is the introduction of a risk-based philosophy. It has also been significantly restructured to follow the format of standards in the ISO 17000 series. In addition, requirements for point-of-care testing, previously addressed in ISO 22870, have been incorporated in the standard.
This brief Information Leaflet, prepared by the Eurachem Education and Training Working Group gives a quick overview of the main changes in the 2022 edition of the Standard.
Availability
The leaflet is currently available in English.
- Download the leaflet in English [309 kB] (2024-06-18)*
Translations
Translation into other languages is encouraged for members of Eurachem. Other offers of translation should be directed to the Eurachem Secretariat for permission. The Eurachem policy on maintenance and development of Eurachem guidance, available on the Policies page, gives further information on translation.
Notes
1. Dates show date of publication of the linked file on this website.
The Eurachem Guide on “Selection, Use and Interpretation of Proficiency Testing (PT) Schemes” recommends participants to consider the statistical approach used by the PT provider when selecting a PT scheme. This leaflet is intended to help participants in quantitative PT schemes to better understand the statistical parameters that are used in the PT report to describe the distribution of results reported by participants.
All proficiency testing schemes include an assessment of laboratory performance. Most compare a laboratory result with an assigned value, and assess performance based on the difference and a criterion for successful performance. Often, this assessment also involves calculating a score for consistent interpretation across rounds and, sometimes, across PT schemes. But there are many different ways of determining an assigned value and setting a criterion for performance assessment, and there are several different scoring methods. 
This leaflet is intended as a comprehensive checklist outlining the key steps to consider when participating in a proficiency testing (PT) scheme. Selection of an appropriate PT scheme must be ensured [1]. It provides essential tips to help participants avoid common mistakes and achieve successful outcomes. The main stages of PT participation are covered, from receipt of PT items through to the review of received evaluations [1-3]. Documentation of outcomes for many of the topics addressed below is recommended, particularly for accreditation purposes.