ISO 15189:2022 – A new task for medical laboratories

Significance of the topic

The 2022 revision of ISO 15189 introduces a risk-based, patient-centered approach to the management and technical operation of medical laboratories. For laboratories accredited to earlier editions, the update requires a systematic transition by December 2025. Understanding the new philosophy and practical implications is essential for clinical laboratories, accreditation bodies, quality managers and technical staff to maintain regulatory compliance, protect patient safety and ensure the reliability of diagnostic results.

Objectives and overview of the document

This guidance summarises the principal changes introduced in ISO 15189:2022, explains their practical impact on laboratory operations and describes recommended steps for a smooth transition. The document highlights structural alignment with other ISO standards, the introduction of risk-based thinking across processes, updated requirements for point-of-care testing (POCT), and refinements to technical and management system expectations.

Key changes introduced in ISO 15189:2022

• Reorganisation of the Standard to follow the ISO 17000-series structure, increasing alignment with ISO/IEC 17025.
• Formal incorporation of a risk-based approach covering pre-examination, examination and post-examination processes.
• Removal of the explicit requirement for documented preventive actions; emphasis placed on planning actions to address risks and opportunities.
• Integration of POCT requirements previously found in ISO 22870.
• No mandatory requirement for a quality manual or a named Technical/Quality Manager; flexibility in how the management system is documented.
• Explicit cross-references to other relevant standards (e.g., ISO 9001, ISO 17511, ISO 20658) and updated annex material.

Methodology and normative references

The Standard expects laboratories to apply a systematic, documented approach to identify, assess and control risks and opportunities across all phases of testing. Risk assessment should consider impact on patient care, likelihood of occurrence and detectability. Sources for identifying opportunities include management review, audits, complaints, personnel input and external quality assessment (EQA) data.
Normative and informative references important for implementation include ISO 9001 (quality management frameworks), ISO 22367 (application of risk management to medical laboratories), ISO 17511 (metrological traceability for in vitro diagnostics), ISO 20658 (sample collection and transport) and ISO/TS 20914 (guidance for estimating measurement uncertainty).

Main results and discussion

• Risk-based philosophy: The Standard embeds risk management into most clauses, shifting emphasis from reactive corrective/preventive actions to proactive risk mitigation and continual improvement. Laboratories must plan and implement actions addressing identified risks and opportunities to safeguard patient outcomes and staff safety.
• Management system flexibility: While ISO 15189 no longer mandates a quality manual or a named technical manager, it permits alignment with ISO 9001-based systems where appropriate. Documentation must nevertheless cover the content traditionally found in a quality manual via other management system elements.
• Expanded pre-examination requirements: More detailed expectations for sample collection, handling and traceability have been added, with explicit cross-references to recent standards governing collection and transport.
• Metrological traceability and measurement uncertainty: The Standard clarifies traceability requirements and accepts alternative approaches. Unlike ISO/IEC 17025, ISO 15189 does not require reporting measurement uncertainty in test reports and excludes sampling as a standalone scope item for uncertainty evaluation.
• Data and information control: The revised text strengthens requirements around information management to reflect advances in digital systems and laboratory information management.
• External provision controls: Requirements for oversight of externally provided products and services (e.g., sample collection, calibration, maintenance, EQA programmes and referral testing) have been expanded.

Benefits and practical applications

• Enhanced patient focus: Embedding risk-based controls across processes helps reduce diagnostic errors and mitigates threats to patient safety.
• Operational alignment and efficiency: Conforming to a structure similar to ISO 17025 and allowing ISO 9001-compatible management systems can simplify integration with broader organisational quality programs.
• Clearer POCT governance: Inclusion of POCT requirements in the main Standard clarifies expectations for oversight, competence and quality assurance of decentralized testing.
• Better oversight of outsourced services: Stronger requirements for external providers support consistent quality of suppliers and referral partners.

Steps laboratories should follow to implement the Standard

1. Study the new Standard to understand both its risk-based philosophy and detailed requirements.
2. Use the Standard's Annex C cross-reference table to map new clause titles to the 2012 edition; perform a detailed cross-walk between existing processes and the new clauses.
3. Update documentation and processes to address widened expectations around risks and opportunities, pre-examination controls and information management.
4. Use internal audits and management review to evaluate readiness and identify gaps.
5. Retain a quality manual if useful, ensuring its contents are represented elsewhere in the management system if a manual is not maintained.
6. Specifically update POCT oversight plans now that ISO 22870 has been withdrawn and its requirements are incorporated into ISO 15189.
7. Complete the transition to the 2022 edition by the ILAC-required deadline of December 2025.

Future trends and potential applications

• Stronger integration of risk management and digital tools: Expect broader use of data analytics, performance indicators and automated monitoring to identify risks and opportunities in near real time.
• Harmonisation across accreditation standards: Continued convergence of ISO 15189, ISO/IEC 17025 and ISO 9001 principles is likely, facilitating multi-domain accreditation strategies.
• Greater emphasis on supply-chain and service-provider governance: As laboratories rely more on external services and devices, accreditation expectations for supplier oversight will grow stricter.
• Evolution of POCT governance: With POCT requirements embedded in ISO 15189, guidance and tools for decentralized testing quality assurance will expand, especially for near-patient and home testing.

Conclusion

ISO 15189:2022 represents a paradigm shift to a risk-based, patient-centered approach in medical laboratory accreditation. Laboratories must proactively assess and manage risks across pre-analytical, analytical and post-analytical stages, update documentation and oversight of external services, and prepare for enhanced data and POCT governance. The allowed flexibility in management-system format (including use of ISO 9001) can aid implementation, but meeting the December 2025 transition deadline requires focused planning, internal auditing and management review.

References

• 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.