ISO 15189
Quick facts
| Category | Medical laboratory quality and competence standard |
|---|---|
| Used by | Medical and clinical laboratories, hospital laboratories and diagnostic testing facilities |
| Also called | None widely standardized |
| Related standards | ISO 17025, ISO 9001 |
| Related processes | Calibration management, document control, internal audit, risk assessment |
| Semantic match | ISO 15189, medical laboratory quality standard, medical lab accreditation, clinical laboratory competence |
What is ISO 15189?
ISO 15189 sets out requirements specific to medical laboratories, combining general laboratory competence principles, similar to those in ISO/IEC 17025, with medical-specific requirements centered on patient safety and clinical relevance.
Unique to ISO 15189 are requirements covering the full testing process from a clinical perspective: pre-examination procedures such as patient preparation and specimen collection, examination processes covering the testing itself, and post-examination processes such as result interpretation, communication with clinicians and critical value notification when a result indicates immediate patient risk.
Because ISO 15189 was developed based on ISO/IEC 17025 and ISO 9000 principles, medical laboratories pursuing accreditation benefit from a framework harmonized with broader laboratory and quality management practices, while addressing the clinical-specific context ISO/IEC 17025 does not cover.
Why is ISO 15189 important?
ISO 15189 accreditation gives clinicians, patients and healthcare organizations confidence that a medical laboratory's results are accurate, timely and appropriately communicated, directly supporting patient safety.
The standard's emphasis on critical value notification and turnaround time significance reflects the reality that laboratory results can carry immediate clinical consequences, a dimension general testing laboratory standards do not address.
For laboratories performing both clinical and non-clinical testing, understanding the distinction between ISO 15189 and ISO/IEC 17025 ensures the right standard, or combination of both, is applied to each type of activity.
How does ISO 15189 work?
ISO 15189's core requirement areas include:
- Pre-examination processes. Manage patient preparation, specimen collection and handling.
- Examination processes. Ensure method validation, equipment calibration and technical competence.
- Post-examination processes. Interpret results and communicate findings, including critical values, to clinicians.
- Quality management system. Maintain documentation, risk management and continuous improvement.
- Risk and safety management. Address biosafety, data confidentiality and patient risk.
- Accreditation. Undergo assessment by an authorized accreditation body.
ISO 15189 vs. ISO 17025
| Comparison | ISO 15189 | ISO 17025 |
|---|---|---|
| Applies to | Medical laboratories specifically | Testing and calibration laboratories generally |
| Unique focus | Pre- and post-examination clinical processes, critical values | General technical competence and impartiality |
Real-world examples of ISO 15189
A hospital laboratory pursues ISO 15189 accreditation to demonstrate its clinical testing meets internationally recognized quality and competence requirements, supporting confidence among referring clinicians.
A diagnostic laboratory establishes a defined critical value notification process under ISO 15189, ensuring clinicians are alerted immediately when a test result indicates urgent patient risk.
A laboratory performing both clinical testing and environmental research testing pursues dual accreditation, using ISO 15189 for its clinical work and ISO/IEC 17025 for its non-clinical testing activities.
Regulations and standards related to ISO 15189
ISO 15189 accreditation is granted by an authorized accreditation body, and under frameworks such as the International Laboratory Accreditation Cooperation Multilateral Recognition Arrangement, accreditation to either ISO 15189 or ISO/IEC 17025 is generally recognized internationally for the scope each standard covers.
Medical laboratories should confirm which standard, or combination of standards, applies to their specific testing activities, since clinical testing falls under ISO 15189 while non-clinical laboratory work may fall under ISO/IEC 17025.
How QT9 helps with ISO 15189
QT9 QMS capabilities supporting ISO 15189 compliance
- Manage laboratory documentation, risk assessment and corrective actions in one system.
- Support calibration management for laboratory equipment and instruments.
- Maintain audit-ready records for accreditation body assessments.
- Automate document control for laboratory procedures and policies.
- Track training and competence records for laboratory personnel.
- Integrate laboratory quality data with broader organizational QMS processes.
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Common mistakes with ISO 15189
Common mistakes include applying ISO/IEC 17025 principles to a medical laboratory without addressing the clinical-specific requirements ISO 15189 adds, such as critical value notification and specimen handling.
Other problems include failing to maintain robust risk and safety management practices addressing biosafety and patient data confidentiality, both specifically emphasized under ISO 15189.
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