ISO 15189:2022 – A new task for medical laboratories

Significance of the topic

The 2022 revision of ISO 15189 introduces a fundamental shift in how medical laboratories manage quality and technical competence. By embedding a risk-based philosophy and aligning its structure with other ISO 17000-series standards, the new edition aims to make laboratory management more proactive, patient-focused and interoperable with other management systems. This change has practical consequences for laboratory governance, pre-analytical and analytical processes, point-of-care testing (POCT), data management and external interactions such as proficiency testing and supplier control.

Objectives and overview of the document

This summary synthesizes the principal updates in ISO 15189:2022, highlights the consequences for medical laboratories and outlines steps for a compliant transition by the ILAC-mandated deadline (December 2025). Key topics covered include structural changes, the introduction of risks and opportunities, altered requirements for preventive actions and POCT, enhanced requirements for metrological traceability and external provisions, and differences versus ISO/IEC 17025.

Methodology and approach of the Standard

ISO 15189:2022 revises the standard by adopting the high-level structure used across ISO management standards, integrating risk-based thinking across clauses and embedding technical requirements for routine and POCT services. Rather than experimental methods, the Standard prescribes system-level processes: risk identification and assessment (impact, likelihood, detectability), planning and implementation of actions addressing risks and opportunities, and mechanisms for continual improvement via audits, management review and data analysis. The Standard permits use of an ISO 9001-compliant quality management system as a foundation, provided it demonstrably satisfies both management and technical requirements.

Main changes and requirements

• Structure: The Standard now follows the ISO 17000-series format, facilitating alignment with ISO/IEC 17025 and ISO 9001.
• Risk-based philosophy: Risk management must be applied across pre-examination, examination and post-examination processes with a focus on patient care and staff safety. Laboratories assess impact, occurrence probability and detectability and plan actions for risks and opportunities. The Standard no longer refers explicitly to preventive actions; instead it requires planning to address risks and opportunities.
• POCT integration: Requirements previously in ISO 22870 have been incorporated into ISO 15189; ISO 22870 has been withdrawn.
• Management system flexibility: A dedicated quality manual or a named Technical/Quality Manager is not mandatory; nonetheless, all expected quality manual content must be covered within the management system. Using ISO 9001 as a basis can simplify compliance.
• Pre-examination and sampling: More detailed requirements for sample collection and pre-examination processes are included, with references to recent standards for sample collection and transport.
• Metrological traceability and measurement validity: The Standard expands on metrological traceability concepts, acknowledges alternative approaches, and references standards for traceability of assigned values. Additional tools and stricter expectations for participation in external quality assessment (EQA) programs are defined.
• Information and data control: More detailed controls and requirements are introduced for data and information management, reflecting technological advances.
• External provisions: Strengthened requirements for externally provided products and services (e.g., sample collection, calibration, equipment maintenance, EQA providers, referral labs, consultants).

Main results and discussion (implications for laboratories)

ISO 15189:2022 moves laboratories from a primarily prescriptive compliance model to a risk-informed, outcome-oriented framework. Laboratories must: identify and evaluate risks across all phases of testing, demonstrate that systems and controls mitigate risks to patient care, document opportunities for improvement and implement actions for continual improvement. Incorporation of POCT requirements places greater emphasis on governance, competency and oversight for decentralized testing. Enhanced requirements for traceability, EQA participation and data control raise the bar for validating result reliability and comparability.

Compared with ISO/IEC 17025, ISO 15189 retains a patient-centred scope and omits sampling as a stand-alone activity; components of sampling are excluded from measurement uncertainty evaluation and there is no explicit requirement to report measurement uncertainty. These differences reflect the clinical focus of ISO 15189 and specific obligations for patient safety and rights.

Benefits and practical applications

• Improved patient safety and outcome focus by systematically managing risks that affect test results and reporting.
• Better alignment with other management systems (ISO 9001, ISO/IEC 17025) facilitating integrated quality management and external recognition.
• Stronger governance of POCT and external service providers, reducing variability across decentralized testing sites.
• Enhanced confidence in result validity through clearer traceability requirements and stricter EQA expectations.
• Flexible documentation model: laboratories can retain useful tools such as a quality manual without being required to maintain one.

Steps laboratories should follow for transition

1. Study the new Standard to understand its risk-based philosophy and structural changes; consult Annex C (Table C1) to compare with the 2012 edition.
2. Map existing processes and documentation to the new clauses to identify gaps, especially in risk management, POCT governance and data management.
3. Revise or create procedures to address risks and opportunities and to document actions and monitoring for continual improvement.
4. Use internal audits and updated management reviews to validate the revised system and readiness for accreditation transition.
5. Retain or adapt quality manual content where useful; update training and competency records for personnel and POCT operators.
6. Ensure external providers (sample collectors, calibrators, EQA vendors, referral labs, consultants) meet the tightened selection and oversight requirements.
7. Complete transition activities before the ILAC deadline of December 2025.

Future trends and potential applications

Adoption of ISO 15189:2022 will likely accelerate harmonization of laboratory quality systems across clinical and testing laboratories, encouraging interoperability with ISO 9001 and ISO/IEC 17025 frameworks. Expect increased use of data analytics to identify opportunities and risks, expanded digital controls for information management, and greater central oversight of POCT networks. Evolving metrological approaches and alternative traceability strategies will influence how clinical laboratories validate methods and interpret comparability across platforms. Finally, enhanced supplier and external service oversight may drive consolidation of accredited EQA providers and calibration services tailored to clinical needs.

Conclusion

ISO 15189:2022 represents a paradigm shift towards a risk-based, patient-centric management of medical laboratories. While aligning structurally with other ISO standards, it preserves clinical-specific requirements and raises expectations for traceability, EQA participation, POCT governance and data control. Laboratories should proactively map current systems to the new requirements, strengthen risk management across all testing phases and complete accreditation transition activities by December 2025 to maintain conformity and demonstrate competence.

Reference

1. ISO 22870:2016, Point-of-care-testing (POCT) – Requirements for quality and competence (withdrawn).
2. ISO 9001:2015, Quality management systems – Requirements.
3. Eurolab Cookbook no 18 Risk based approach.
4. ISO 22367:2020, Medical laboratories – Application of risk management to medical laboratories.
5. ISO 20658:2023, Requirements for the collections and transport of samples for medical laboratory examinations.
6. ISO 17511:2020, In vitro diagnostic medical services – Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples.
7. ISO/TS 20914:2019, Medical laboratories – Practical guidance for the estimation of measurement uncertainty.