ISO/IEC 17025:2017 applies to testing and calibration laboratories of any kind, such as food, water, environmental, pharmaceutical QC and calibration labs. ISO 15189:2022 applies to medical laboratories that examine human samples to support patient care. If your results are used to diagnose, treat or monitor a patient, ISO 15189 is normally the right standard; if they describe a product, material, environment or instrument, it is ISO/IEC 17025.
The choice shapes your quality system and what assessors expect. Forcing one lab's work into the other standard creates gaps that show up at assessment.
What each standard covers
ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories, is used by food and water testing labs, environmental labs, contract pharmaceutical QC labs, materials and construction testing, and calibration labs. Its focus is technically valid results, metrological traceability and impartial reporting to customers.
ISO 15189:2022, Medical laboratories: Requirements for quality and competence, is written for clinical laboratories: biochemistry, haematology, microbiology, molecular diagnostics, histopathology and similar. It covers the whole patient pathway, from request and sample collection to reporting, interpretation and clinical advice. It also includes point-of-care testing (POCT), with additional requirements in Annex A.
Shared structure since 2022
The 2022 edition of ISO 15189 was aligned with the structure of ISO/IEC 17025:2017. Both now follow the same clause pattern:
- Clause 4: general requirements, including impartiality and confidentiality
- Clause 5: structural requirements
- Clause 6: resource requirements, including personnel, facilities, equipment and externally provided services
- Clause 7: process requirements
- Clause 8: management system requirements, with Option A and Option B
This makes life easier for organisations running both types of lab. Document control, internal audit, management review, complaints and supplier evaluation can share one framework, with discipline-specific procedures where the standards differ.
ISO 17025 vs ISO 15189: comparison table
| Aspect | ISO/IEC 17025:2017 | ISO 15189:2022 |
|---|---|---|
| Scope | Testing and calibration laboratories in any sector | Medical laboratories examining human samples |
| Typical labs | Food, water, environmental, pharma QC contract, materials, calibration | Hospital, diagnostic and reference clinical labs, including POCT |
| Customers | Clients, manufacturers, regulators, internal users | Patients, clinicians and healthcare organisations |
| Process emphasis | Test or calibration methods, sampling, handling of test items | Pre-examination, examination and post-examination processes |
| Unique requirements | Sampling, decision rules and statements of conformity, calibration certificates | Patient requirements, reference intervals, critical result communication, advisory services, POCT |
| Risk focus | Risks and opportunities affecting the validity of results and the lab's activities | Risks to patients across the examination process |
| Personnel | Competence for the tests or calibrations performed | Also a qualified laboratory director with defined responsibilities |
| Accreditation bodies | National bodies, e.g. NABL in India; e.g. EIAC in the UAE; confirm with your national accreditation body | Same national bodies, under a medical laboratory programme |
Requirements unique to each standard
Only in ISO/IEC 17025
ISO/IEC 17025 includes requirements for sampling where the lab samples items for later testing, such as a food lot or a water supply. It also has detailed rules on statements of conformity: when a report states pass or fail against a specification, the lab must apply a documented decision rule that accounts for measurement uncertainty. Calibration labs have specific requirements for calibration certificates. For more detail, see our ISO 17025 accreditation roadmap.
Only in ISO 15189
ISO 15189 covers areas that make sense only in patient care. These include requirements regarding patients, request information and patient preparation, sample collection, biological reference intervals and clinical decision limits, communication of critical results, interpretive comments and advisory services. POCT governance is also covered. Our ISO 15189:2022 checklist walks through these clause by clause.
When labs hold both
Some laboratories legitimately hold both accreditations, because they do both kinds of work. Common examples include:
- A private lab group with a clinical division and a food or water testing division
- A public health laboratory testing patient samples and food, water or environmental samples during outbreak investigations
- A molecular lab running clinical PCR for patients and pathogen detection in food or environmental samples
Each accreditation is scope-specific, so the same lab may have one scope under ISO 15189 and another under ISO/IEC 17025. Assessments may be combined or held separately, depending on the accreditation body's arrangements.
Decision guide: which standard applies to your lab?
- Are the results used for the diagnosis, treatment, monitoring or prevention of disease in a person? If yes, ISO 15189 is normally the right standard.
- Do you test products, materials, food, water, environmental samples or animal samples? If yes, ISO/IEC 17025.
- Do you calibrate instruments or equipment for others or yourself? ISO/IEC 17025.
- Do you test human samples for non-clinical purposes? Check your accreditation body's policy, as some such work falls under ISO/IEC 17025.
- Do you do more than one of the above? You may need both, with separate scopes.
- Still unsure? Ask your national accreditation body before investing in documentation.
Regulatory and licensing requirements are separate from accreditation. A health authority licence, a food authority approval or a GMP inspection does not replace either standard, and accreditation does not replace them. Confirm with the relevant regulator in your country or emirate.
Worked example: a Dubai lab doing food and clinical testing
A private laboratory in Dubai has two divisions. The food division tests imported foods for microbiology and chemical contaminants for traders and manufacturers. The clinical division performs routine biochemistry, haematology and molecular tests for outpatient clinics.
Management first considers one accreditation for everything, but the quality manager explains why that will not work. Food results go to clients who need statements of conformity against specifications, with decision rules that account for measurement uncertainty. Clinical results go to doctors who need reference intervals, critical result calls and interpretive comments. Each standard is written for one of those needs.
The lab builds one integrated management system, with a common quality manual, document control, internal audit programme, management review and complaints process. Below that sit two sets of process procedures: an ISO/IEC 17025 set for sampling, test item handling and conformity statements, and an ISO 15189 set for pre-examination, critical results and advisory services.
Shared resources such as purchasing are documented once, with records showing how they meet both standards. The lab applies for two scopes, confirms assessment arrangements in advance and trains internal auditors in both standards.
Common mistakes
- Seeking ISO/IEC 17025 for clinical diagnostics because it seems more familiar
- Assuming the shared structure means the standards are interchangeable
- Writing statements of conformity on food reports without a documented decision rule
- Ignoring pre-examination and critical result requirements in a clinical lab moving from ISO/IEC 17025 habits
- Running two separate quality systems where one integrated system would be simpler
- Confusing accreditation with licensing or GMP approval
Key takeaway: Choose the standard by what your results are used for. Patient care points to ISO 15189:2022; products, environments and calibrations point to ISO/IEC 17025:2017. Labs doing both can run one integrated system with two scopes.
Frequently Asked Questions
What is the difference between ISO 15189 and ISO 17025?
ISO 15189:2022 is written for medical laboratories and covers the full patient pathway, including sample collection, reference intervals, critical results and clinical advice. ISO/IEC 17025:2017 applies to testing and calibration labs in any sector, with requirements on sampling, decision rules and calibration certificates. Since 2022 the two standards share a similar clause structure.
Can a medical laboratory be accredited to ISO 17025?
Medical laboratories examining human samples for patient care are normally accredited to ISO 15189, which addresses patient-specific requirements that ISO/IEC 17025 does not. Some labs that test human samples for non-clinical purposes may fall under ISO/IEC 17025. Check the policy of your national accreditation body, such as NABL in India or EIAC in the UAE.
Is ISO 15189 based on ISO 17025?
The two standards share common roots and many technical requirements, and the 2022 edition of ISO 15189 was aligned with the structure of ISO/IEC 17025:2017. ISO 15189 adds requirements specific to medical laboratories, such as patient requirements, pre-examination processes, reference intervals and point-of-care testing.
Which standard applies to a food testing laboratory?
Food testing laboratories are normally accredited to ISO/IEC 17025:2017, because they test products for clients and often issue statements of conformity against specifications. Food authorities may also have their own approval or recognition schemes for laboratories, so confirm requirements with the relevant authority in your country or emirate.
Can one laboratory hold both ISO 15189 and ISO 17025?
Yes. A laboratory that performs both clinical examinations and testing or calibration can hold both accreditations, each with its own scope. Many such labs run one integrated management system with procedures specific to each standard. Ask your accreditation body how assessments for the two scopes will be arranged.
Next steps
If you work in testing or calibration, our ISO/IEC 17025 Advanced: Laboratory Competence & Accreditation course covers the standard in depth. For clinical labs, ISO 15189 Advanced: Medical Laboratory Quality & Competence is the natural fit. For related reading, see our ISO 17025 accreditation roadmap and ISO 15189:2022 checklist. If you need help deciding, speak to a counsellor.
Looking for structured certification?
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