The European Accreditation Cooperation (EA) has published EA-4/23, a new guidance document for the assessment and accreditation of opinions and comments in laboratory reports. Based on the ISO/IEC 17025:2017 standard, the new guidance aims to ensure unity of practice among National Accreditation Bodies (NABs) across Europe and provide greater clarity for laboratories and their customers. EA-4/23 was approved on March 27, 2025 and became effective as of April 30, 2025, with no transition period foreseen.
While the new guidance is of primary relevance to testing and calibration laboratories, it can also offer indirect benefits for medical laboratories. EA-4/23 requires laboratories to clearly define the boundaries of the opinions and interpretations they provide, to have authorized personnel for these activities, and to clearly document this process in their management systems.
Laboratories will be obliged to ensure that the opinions and comments they give in their reports are based solely on the products tested or calibrated and are clearly stated. It is also emphasized that these comments should not be confused with product certification or declaration of conformity. In particular, although laboratories may also provide opinions and comments on outsourced testing services, they must certify that these services are accredited and that an unbroken chain of accreditation is maintained.
For customers, the EA-4/23 will enable them to be confident that the opinions and interpretations contained in laboratory reports are consistent, professional and reliable. This will increase confidence in the accuracy of reports, especially in critical industries.
EA-4/23 also makes recommendations to National Accreditation Bodies to make the authority to comment more visible in accreditation documents. This will make it easier for customers to see in which activities a laboratory can provide opinions and comments.
The EA’s guidance is seen as an important step towards improving quality and reliability in the laboratory sector.
For More Information: EA-4-23
