When it comes to quality and competence in the life sciences, two international standards are most frequently mentioned: ISO 20387 and ISO 15189. At first glance, they may appear similar, since both address laboratories, quality, and competence. However, they actually serve very different domains: one is designed for patient health and clinical decisions, while the other is intended for research, development, and biobanking.
Understanding this distinction is critical not only for compliance but also for ensuring reliability, transparency, and global collaboration. If your organization works with biological samples or provides medical testing services, knowing which standard applies to you is of vital importance.
What is ISO 15189?
ISO 15189: Medical laboratories — Requirements for quality and competence is regarded as the gold standard for medical laboratories worldwide. This standard ensures that diagnostic test results are accurate, reliable, and traceable. In doing so, it directly impacts patient safety and clinical decision-making.
Key points of ISO 15189:
- Accuracy and reliability: Guarantees that test results are correct and reproducible.
- Competent personnel: Requires documented competence, continuous training, and clearly defined responsibilities.
- Quality management system: Covers all processes from sample collection (pre-analytical), to the testing process (analytical), and reporting phase (post-analytical).
- Patient-centeredness: Links laboratory activities directly to clinical outcomes and regulatory requirements.
In short, ISO 15189 is the standard of trust in medicine. When physicians make treatment decisions, they rely on laboratory results — and behind this trust stands ISO 15189.
What is ISO 20387?
ISO 20387: Biotechnology — Biobanking — General requirements is a newer standard, designed specifically for biobanks. Biobanks are organizations that collect, process, store, and distribute biological materials of human, animal, plant, or environmental origin for research and development purposes.
Key points of ISO 20387:
- Governance body: Requires the presence of an independent body that provides advice on scientific, technical, and administrative matters.
- Sample integrity: Ensures that biological materials are stored under conditions that prevent degradation and allow long-term use.
- Ethics and consent: Places strong emphasis on informed consent, ethical oversight, and legal compliance.
- Support for reproducibility: Through standardized processes, researchers can obtain comparable results worldwide.
- Broad scope: While ISO 15189 focuses solely on human health laboratories, ISO 20387 also covers biobanks used in biotechnology, pharmaceuticals, agriculture, and environmental studies.
In short, ISO 20387 is the standard of trust in research. Scientists rely on biobanks accredited to this standard to provide reliable and ethically sourced biological materials.
Key Differences Between ISO 20387 and ISO 15189
| Area | ISO 15189 | ISO 20387 |
| Scope | Clinical and medical laboratories | Biobanks (human, animal, plant, environmental)) |
| Core Purpose | Patient diagnosis, treatment decisions, and clinical care | To support scientific research and innovation |
| Users | Patients, physicians, hospitals, health authorities | Researchers, biotechnology companies, pharmaceutical industry |
| Quality Focus | Accuracy and reliability of diagnostic results | Integrity, traceability, and ethical management of biological samples |
| Governance | Patient confidentiality, clinical ethics, health regulations | Governance board, ethical oversight, and informed consent |
| Impact | Direct impact on patient health | Indirect contribution to reliable science and future treatments |
Why Is This Difference Important?
The distinction between ISO 15189 and ISO 20387 is not merely technical; it has real-world consequences:
- For hospitals and diagnostic laboratories: ISO 15189 accreditation demonstrates competence and reliability in patient-centered services.
- For biobanks and research centers: ISO 20387 accreditation shows commitment to transparency, ethical principles, and the reliability of samples.
- For global collaborations: It prevents confusion. While a research center may require ISO 20387-accredited samples, a health authority expects diagnostic results compliant with ISO 15189.
- For industrial innovation: Pharmaceutical development, biotechnology initiatives, and agricultural research all rely on both standards to ensure trustworthy data and products.
Common Ground: Quality and Competence
Although the two standards serve different purposes, they share key principles:
- Both require documented processes and quality management systems.
- Both demand the use of competent personnel.
- Both aim to build trust: ISO 15189 ensures patient trust, while ISO 20387 guarantees scientific reliability.
Institutions such as university hospitals with biobanks may opt for both accreditations to secure credibility in both patient services and research.
Conclusion
While ISO 15189 and ISO 20387 appear similar, their missions differ. ISO 15189 ensures the competence of medical laboratories and patient safety, whereas ISO 20387 guarantees that biobanks provide reliable, traceable, and ethically managed samples for research.
For institutions operating at the intersection of health and biotechnology, understanding this difference is critical. Choosing the right standard—or, in some cases, applying both—is not only about compliance but also about achieving global recognition, fostering collaboration, and contributing reliable knowledge to science.
In today’s landscape of cross-border research, personalized medicine, and biotechnology-driven innovation, aligning with the right ISO standard is not merely an obligation; it is also a secure investment in the future.
Author: Z. Naz Ayvaz