ISO 15189:2022 – A new task for medical laboratories

ISO 15189:2022 — A new task for medical laboratories

Significance of the topic

• The 2022 revision of ISO 15189 introduces a risk-based management philosophy and a restructured format aligned with the ISO 17000 family. This change is consequential for medical laboratories because it directly affects processes that determine patient safety, diagnostic quality and regulatory compliance. Timely transition to the new edition (by December 2025 for already accredited laboratories) is critical to maintain accreditation and ensure uninterrupted, high-quality laboratory services.

Objectives and overview of the standard

• The revised Standard defines a medical laboratory as an entity that examines human-derived materials to provide information for diagnosis, monitoring, management, prevention and treatment of disease, and assessment of health. It covers pre-examination, examination and post-examination processes.
• Main aims of the 2022 edition are to embed a risk-based approach across laboratory processes, update structural alignment with other ISO standards (notably ISO/IEC 17025), incorporate requirements for point-of-care testing (previously in ISO 22870), and clarify expectations for management systems without mandating a quality manual or specific managerial roles.

Key changes and high-level comparison

• Structure: The Standard now follows the ISO 17000 series format, improving consistency with ISO/IEC 17025 but retaining laboratory-specific requirements.
• Risk and opportunities: A risk-based approach is introduced across almost all clauses; preventive action as an explicit term is removed in favor of planning actions to address risks and opportunities.
• POCT integration: Requirements for point-of-care testing from ISO 22870 are incorporated.
• Management system: No mandatory quality manual or named Technical/Quality Manager; compliance can be supported by ISO 9001-based systems.
• Expanded references and annexes: Additional normative and informative references and annex material guide implementation and transition.

Risk-based approach: expectations and implementation

• Laboratories must identify risks associated with pre-examination, examination and post-examination activities, assessing impact, likelihood of occurrence and detectability. The emphasis is on risks affecting patient care and staff safety.
• Required actions include risk mitigation, reduction of impact, and identification of opportunities for improvement. Sources for identifying improvements include policy reviews, internal audits, complaints, management review, personnel suggestions, data analyses and EQA results.
• The Standard refers laboratories to ISO 22367 (application of risk management) and encourages continuous planning and implementation of actions rather than labeling them as preventive actions.

Management system and documentation

• The Standard allows flexibility in how a laboratory implements its management system; ISO 9001 compliance can facilitate meeting ISO 15189 requirements, provided both technical and managerial obligations are addressed.
• Although a quality manual is not required, its contents must be present within the management system documentation; laboratories already using a manual may retain it.
• Management review processes must explicitly consider risks and opportunities and reflect changes introduced by the new edition.

Pre-examination processes, metrology and quality assurance

• Pre-analytical requirements are more detailed, with references to standards for sample collection and transport (e.g., ISO 20658).
• Metrological traceability is addressed in greater depth, with alternative approaches permitted and references to device-focused standards such as ISO 17511.
• Measurement uncertainty remains a technical consideration; unlike ISO/IEC 17025, ISO 15189 does not mandate reporting uncertainty in routine results. Components from sampling as a stand-alone activity are not included in measurement uncertainty evaluation under ISO 15189.
• Additional and stricter expectations are placed on tools that validate results, including participation in external quality assessment (EQA) schemes and use of control materials.
• Data and information management controls are expanded to account for evolving digital technologies and data handling risks.

Point-of-care testing (POCT) and externally provided services

• Requirements previously covered in ISO 22870 are now embedded in ISO 15189; laboratories performing POCT must align local processes with these integrated requirements.
• External provisions such as sample collection, calibration, maintenance, EQA participation, referral testing and consultancy are more tightly regulated. Laboratories must evaluate and control externally provided products and services to ensure they meet relevant quality and competence needs.

Differences from ISO/IEC 17025 — practical implications

• Scope differences: Sampling is not treated as a stand-alone activity in ISO 15189.
• Measurement uncertainty: ISO 15189 does not require uncertainty to be included in reports; sampling components are excluded from uncertainty evaluation under ISO 15189 conventions.
• Patient-centred focus: ISO 15189 includes requirements specifically concerned with patient welfare, safety and rights that are not present in ISO/IEC 17025.

Practical steps for laboratories to transition

1. Study the Standard to understand both new philosophy and specific provisions; use Annex C (Table C1) to map changes relative to the 2012 edition.
2. Cross-reference existing processes and documentation against the new clause structure and identify gaps, especially in risk management, POCT and data control.
3. Update or create procedures to document risk assessments, planned actions and evidence of opportunities identified through audits, EQA, complaints and data review.
4. Conduct internal audits and a targeted management review to validate the revised system and confirm readiness for external assessment.
5. Retain useful documentation such as a quality manual if it supports clarity, but ensure required content appears elsewhere in the management system.
6. Address POCT requirements explicitly, considering that ISO 22870 has been withdrawn and its content is now within ISO 15189.
7. Plan the transition well ahead of the December 2025 deadline for accredited laboratories to allow for corrective actions and assessor feedback.

Benefits and practical applications

• Adoption of a risk-based approach improves resilience of laboratory processes and aligns laboratory operations with patient-centred quality objectives.
• Structural alignment with other ISO standards can streamline combined accreditation efforts and integration with broader quality systems (e.g., ISO 9001).
• Clearer pre-analytical and external provider requirements reduce sources of error that impact diagnostic accuracy and patient safety.
• Enhanced requirements for EQA and data management strengthen result validity and traceability in increasingly digital and networked laboratory environments.

Future trends and potential applications

• Greater digitalization and connected diagnostics will drive further emphasis on data integrity, cybersecurity, and interoperability between laboratory information systems and clinical records.
• Risk management tools will likely become more formalized and supported by software solutions that integrate incident reporting, risk registers and corrective-action tracking.
• Harmonization across accreditation standards may progress, enabling more consistent global expectations for clinical laboratories and smoother multi-standard compliance.
• Advances in metrological approaches for biological measurands will push development of new reference materials and methods, improving traceability and comparability of clinical results.

Conclusion

• ISO 15189:2022 represents a substantive shift toward a risk-based, patient-centred quality framework for medical laboratories. Laboratories must reassess processes across the entire testing pathway, update documentation and management reviews, and align external service control and POCT practices with new requirements. Proactive transition planning, focused internal audits and targeted updates to quality systems will be essential to meet the December 2025 timeline and to realize improvements in patient safety and result reliability.

Reference

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