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 1st
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.