Comparison · laboratories
ISO 17025 or ISO 15189: it depends on the sample
Both accredit a laboratory's competence and since 2022 they share a structure, so on paper they look very much alike. The dividing line is not size or technique: it is whether the result is used to make a clinical decision about a person.
The short answer
The criterion is simple: if the result serves to diagnose, treat or prevent in a specific patient, the standard is ISO 15189; for everything else — materials testing, water analysis, instrument calibration, product control — it is ISO/IEC 17025. The 2022 edition of ISO 15189 brought the two much closer: it adopted the ISO/IEC 17025 structure and absorbed point-of-care testing, previously covered by the withdrawn ISO 22870.
- ISO/IEC 17025:2017
- Testing and calibrationThird edition, November 2017
- ISO 15189:2022
- Medical laboratoriesDecember 2022; transition closed 6 December 2025
Side by side
What they share and where they part
| Criterion | ISO/IEC 17025:2017 | ISO 15189:2022 |
|---|---|---|
| Object | Competence to test and calibrate | Competence for clinical examination |
| Sample type | Materials, products, water, instruments | Samples of human origin |
| Current edition | 2017 | 2022, with the transition closed in December 2025 |
| Structure | Impartiality, resources, process and management | The same since the 2022 edition |
| Risk approach | Risks and opportunities for the laboratory | Risk centred on the impact on the patient |
| Distinctive point | Decision rule when declaring conformity | Pre-analytical phase and point-of-care testing |
| Absorbed standard | — | ISO 22870 (POCT), withdrawn and integrated |
| Accreditation in Spain | ENAC | ENAC |
How to decide
Which one is yours
ISO/IEC 17025:2017
Yours if…
- You test materials, food, water or industrial product
- You calibrate instruments for third parties or for your own plant
- You issue batch certificates of analysis for a customer
- Your result feeds a quality control, not a clinical decision
ISO 15189:2022
Yours if…
- You analyse samples of human origin for diagnostic purposes
- A clinician interprets your results to treat a patient
- You carry out point-of-care testing
- You need to manage risk from the patient's perspective
Frequently asked questions
What people ask us before getting started
Can a laboratory hold both?
Yes, and it happens where clinical analysis sits alongside testing that is not clinical, such as water or surface control. Since ISO 15189 adopted the ISO/IEC 17025 structure, keeping both costs considerably less than it used to.
What is the decision rule?
It is how measurement uncertainty is accounted for when declaring whether a result meets the specification. ISO/IEC 17025 requires agreeing it with the customer and documenting it, because a value sitting right on the limit means different things depending on the rule applied.
What changed with ISO 15189:2022?
It was reorganised to align with ISO/IEC 17025, explicitly absorbed the point-of-care testing previously covered by ISO 22870 — now withdrawn — and strengthened risk management from the patient's perspective.
Does ISO 9001 replace either of these?
No. ISO 9001 certifies a quality management system but does not accredit technical competence: it says nothing about whether the laboratory can measure. They are different things and do not substitute for each other.
Must uncertainty be estimated in both?
Yes, both require it. The difference is in how it is communicated: in the clinical setting what matters is that the clinician can interpret the result in context.
What about the pre-analytical phase?
It is where much of a medical laboratory's error concentrates — identification, collection, transport, storage — and ISO 15189 gives it specific attention. In ISO/IEC 17025 the equivalent is sampling, treated in less detail because the scenario differs.
One system that serves both accreditations
We'll show you the module running with data similar to yours.
Sources
Where each figure comes from
References to the official text in force. If a standard is revised, this page is updated and the review date says so.
- ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories ISO/IEC · November 2017
- ISO 15189:2022 — Medical laboratories. Requirements for quality and competence ISO · December 2022
- Entidad Nacional de Acreditacion ENAC · Official portal
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Differences between ISO 17025 and ISO 15189
ISO/IEC 17025 accredits the competence of testing and calibration laboratories, and ISO 15189 that of medical laboratories. What separates them is not size or technique but whether the result is used to make a decision about a specific patient.
Since the 2022 edition, ISO 15189 shares its structure with ISO/IEC 17025 — impartiality, resources, process and management system — and integrates the point-of-care testing previously covered by the withdrawn ISO 22870, which makes holding both accreditations on one system considerably simpler.