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Posted on 22 Mar,2026

Overview of ISO 15189:2022 – Key Changes and Requirements

ISO 15189:2022 is the latest international standard that specifies requirements for quality and competence in medical laboratories. Effective 1^st January 2026, the 2017 version has been passed out and replaced with the 2022 version of the standard with the latter version aligning more closely with ISO/IEC 17025:2017.  It introduces a modern, risk-based and process-oriented approach. The revised standard focuses on improving patient safety, enhancing laboratory efficiency, and ensuring technically valid results.

One of the most significant changes in ISO 15189:2022 is the adoption of a risk-based thinking approach. Laboratories are now required to identify, evaluate, and manage risks and opportunities that could impact the quality of test results. This shift ensures proactive decision-making rather than reactive corrective actions, strengthening overall quality management.

The structure of the standard has also been revised. Instead of rigid clauses, ISO 15189:2022 follows a more flexible framework divided into general requirements, structural requirements, resource requirements, process requirements, and management system requirements. This alignment improves integration with other ISO standards and simplifies implementation for laboratories already accredited under similar frameworks.

Another key change is the increased emphasis on laboratory processes. The standard clearly defines requirements across the total testing process, including pre-examination (sample collection and handling), examination (testing and analysis), and post-examination (reporting and interpretation). This ensures end-to-end quality and traceability of laboratory operations.

Competence of personnel is given greater importance in the updated version. Laboratories must ensure that all staff members are adequately trained, qualified, and continuously assessed for competence. There is also a stronger focus on defining roles and responsibilities, ensuring accountability at every level.

ISO 15189:2022 also strengthens requirements related to equipment, metrological traceability, and measurement uncertainty. Laboratories must ensure proper calibration, maintenance, and performance verification of equipment. The concept of traceability to internationally recognized standards is emphasized to ensure reliability and comparability of results.

The updated standard enhances requirements for quality assurance activities, including Internal Quality Control (IQC) and participation in External Quality Assessment (EQA) or Proficiency Testing (PT) programs. These activities are essential for monitoring performance and maintaining accuracy and consistency of results.

Another important aspect is the focus on information management systems. Laboratories must ensure data integrity, confidentiality, and secure handling of patient information. With increasing digitalization, robust Laboratory Information Management Systems (LIMS) play a crucial role in compliance.

ISO 15189:2022 also promotes continual improvement and customer focus. Laboratories are expected to monitor performance indicators such as turnaround time (TAT), handle complaints effectively, and implement corrective actions where necessary. Patient care and satisfaction remain central to all laboratory activities.

In conclusion, ISO 15189:2022 introduces a more flexible, risk-based, and patient-centred approach to laboratory quality management. By implementing these updated requirements, medical laboratories can enhance their competence, ensure reliable results, and contribute effectively to improved healthcare outcomes.