ISO 15189:2022 — Key Changes and What Your Lab Needs to Do

The International Organization for Standardization published the third edition of ISO 15189 in December 2022, replacing the 2012 version. Labs accredited under the previous version had until 2025 to transition. If your lab has not yet completed the transition, this guide covers the most important changes.

Why ISO 15189 Matters Internationally

ISO 15189 is the global benchmark for medical laboratory quality and competence. It is recognized by accreditation bodies in over 100 countries including UKAS (United Kingdom), NATA (Australia), CALA (Canada), NABL (India), ESMA (UAE), and SAAS (Saudi Arabia). Unlike CLIA or CAP, which are US-centric, ISO 15189 provides a universal framework that allows labs to demonstrate competence to any international stakeholder.

The Five Most Important Changes in ISO 15189:2022

1. Risk-Based Thinking Is Now Central

The 2012 version mentioned risk management but did not require a formal risk management process. The 2022 version requires labs to identify, assess, and manage risks throughout the entire testing process — pre-analytical, analytical, and post-analytical. Labs must document their risk assessment methodology and demonstrate how identified risks are controlled.

What to do: Implement a formal risk register. Document risks for each test method, identify controls, and review the register at management review meetings.

2. Point-of-Care Testing (POCT) Requirements Expanded

ISO 15189:2022 includes significantly expanded requirements for point-of-care testing. Labs that oversee POCT devices in clinics, wards, or remote locations must now ensure those devices are included in the quality management system, operators are competent, and results are integrated into the patient record.

What to do: Create a POCT inventory, establish competency requirements for POCT operators, and include POCT QC in your QC program.

3. Patient and User Focus Strengthened

The new version places greater emphasis on patient safety and the needs of laboratory users (clinicians, patients). Labs must demonstrate they understand user needs and have processes to address complaints and feedback.

What to do: Implement a formal user satisfaction survey and complaint management process. Document how feedback is reviewed and acted upon.

4. Measurement Uncertainty Now Required for All Quantitative Tests

While measurement uncertainty (MU) was required in the 2012 version, the 2022 revision clarifies that MU must be calculated and documented for all quantitative examination procedures. The MU must be communicated to users when clinically relevant.

What to do: Calculate MU for every quantitative test using either the top-down (IQC-based) or bottom-up (component-based) approach. Document the calculation and review it when methods change.

5. Impartiality and Confidentiality Requirements Added

ISO 15189:2022 adds new requirements for laboratory impartiality — labs must identify and manage risks to impartiality from commercial, financial, or other pressures. Confidentiality requirements are also strengthened.

What to do: Conduct an impartiality risk assessment. Document how the lab manages potential conflicts of interest.

Transition Timeline

Most accreditation bodies required labs to transition to ISO 15189:2022 by the end of 2025. If your lab has not yet transitioned, contact your accreditation body immediately to understand the current requirements.

How LabComply Supports ISO 15189:2022

LabComply's quality management module is aligned with ISO 15189:2022 requirements, including risk management documentation, POCT tracking, measurement uncertainty templates, and management review workflows. Labs in the UK, Australia, Canada, UAE, Saudi Arabia, and India use LabComply to manage their ISO 15189 compliance.

[Start your free trial today](https://labcomply.net/register) and see how LabComply simplifies ISO 15189:2022 compliance.