Embracing change – The transition to ISO 15189:2022

The ISO 15189:2022 standard is an internationally recognised standard which has been revised to enhance the quality and competence of medical laboratory services. It plays a crucial role in ensuring the reliability and accuracy of laboratory testing, which is vital for effective patient diagnosis and treatment.

Laboratories accredited under the previous version, ISO 15189:2012, are now required to transition to the updated standard over a three-year period, with a deadline of December 2025. This transition is being managed in the UK by UKAS, with support from the Institute of Biomedical Science (IBMS) and the Royal College of Pathologists (RCPath).

To ensure laboratories adhere to the updated requirements, it is mandatory for all annual UKAS assessments of ISO 15189-accredited laboratories to include a transition assessment. UKAS has conducted over 100 transition assessments so far, supporting laboratories toward compliance with the new standards.

Understanding the transition requirements

Laboratories currently accredited under ISO 15189:2012 must undertake a thorough review of the new ISO 15189:2022 standard, identify any gaps in compliance through a detailed gap analysis, and take documented steps to implement the new requirements. Key updates in the new standard emphasise the clinical risks and impact of pathology services of patients, including specific requirements for point-of-care testing, which are critical for maintaining and enhancing quality and competence in laboratory services.

Key changes and their impact

The new standard places a heightened focus on risk management, which reflects a broader trend towards prioritizing patient welfare in healthcare protocols.

Another notable change in the ISO 15189:2022 revision is the integration of the requirements for point-of-care testing (POCT) previously covered separately under ISO 22870:2016. This integration aims to streamline standards and bring POCT to the forefront of laboratory accreditation, enhancing the cohesion between lab-based tests and point-of-care services.

Trending non-conformities

A number of trends have been noted in the non-conformities identified during the transition assessments which have taken place. This review of the trends is designed to assist laboratories in understanding the common pitfalls during the transition process and to emphasise the importance of compliance in critical areas that directly impact patient care and laboratory quality.

Personnel authorisation and competence (Clause 6.2.3)

One of the trends identified relates to the authorisation of personnel to perform specific laboratory activities, which include the selection, validation, and verification of methods, as well as the review and reporting of results. The transition assessments have revealed that some services have not fully implemented systems to ensure that only appropriately authorised personnel are handling these, and other, critical tasks. This gap can lead to inconsistencies in test results and compromise the integrity of laboratory services.

Verification and periodic review of examination methods (Clauses 7.3.1e and 7.3.2d)

Another trending non-conformity is the lack of involvement of clinical personnel in reviewing verification reports and periodically reviewing examination methods to ensure their ongoing clinical appropriateness. This requirement is crucial to maintaining the relevance and accuracy of diagnostic methods over time.

Evaluation of clinical significance of non-conforming work (Clause 7.5)

The transition to the new standard also places a greater emphasis on the clinical impact of non-conformities. It requires laboratory services to evaluate the clinical significance of any non-conforming work comprehensively. This evaluation is essential to determine the potential patient impact and implement corrective actions. However, assessments have shown that not all laboratories are thoroughly documenting or addressing the clinical implications of non-conformities, which could potentially lead to adverse patient outcomes.

Risk-based audit planning (Clause 8.8.3)

A further area of concern is the planning of audit schedules based on identified risks, non-conformities, and service changes, with a priority on activities that may pose higher risks to patients. Some laboratories have not shown evidence of a risk-based approach to auditing, which is critical for prioritising areas that need urgent attention and ensuring patient safety.

The transition process

UKAS has laid out a comprehensive transition process to facilitate the adoption of ISO 15189:2022. This includes the dissemination of detailed information to accredited laboratories and technical assessors, which is regularly updated and available on the UKAS website. Laboratories are required to conduct thorough gap analyses to determine, and implement, the changes needed in their current systems and processes to comply with the new standard.

Extending accreditation to POCT services

The inclusion of POCT in ISO 15189:2022 is expected to encourage more laboratories to seek accreditation for these services. While historically, accreditation uptake for POCT has been limited, the unified standard provides a clearer path for laboratories to extend their accreditation scope to include these vital services, which are increasingly important in delivering timely diagnostic care.

Looking forward

As the 2025 deadline approaches, UKAS continues to support laboratories through this transition, offering training, resources, and guidance to ensure that all accredited organisations can meet the new standard’s requirements. Laboratories are urged to stay proactive in engaging with UKAS and utilising the available resources to make this transition smooth and successful.

The transition to ISO 15189:2022 is not just about compliance but about embracing a future where quality, competence, and patient safety are at the forefront of laboratory services. This update is an opportunity for all accredited laboratories to enhance their operational effectiveness and contribute to improved patient outcomes.

For further information and updates on the transition to ISO 15189:2022, stakeholders are encouraged to visit the UKAS website, including the ISO 15189:2022 transition information hub regularly.