General requirements for the competence of testing and calibration laboratories
The international standard for laboratory competence, impartiality and consistent operation. Published November 2017 as the third edition, replacing ISO/IEC 17025:2005, it is the standard against which testing and calibration laboratories are accredited worldwide.
What this does not cover
stated in the document's own scope- Addresses laboratory competence for testing and calibration; the conduct of nonclinical safety studies is governed by GLP (OECD GLP Principles / 21 CFR Part 58).
- Is a voluntary standard, not a regulation; any legal duty to use accredited testing comes from a regulator or customer, not from the standard itself.
- Covers testing and calibration laboratories, not medical/clinical laboratories, which are addressed by ISO 15189.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories. It specifies the general requirements a laboratory must meet to be judged technically competent, impartial, and able to produce valid results — covering both the management system that supports the work and the technical basis of the work itself: personnel competence, equipment and calibration, method validation and verification, sampling, measurement traceability, measurement uncertainty, and the reporting of results. Accreditation to ISO/IEC 17025 is granted against a defined scope, and that scope is specific: competence is recognised per method and per matrix, not as a blanket capability.
Scope & applicability
Any organisation performing laboratory activities — contract testing laboratories, calibration providers, and in-house laboratories seeking accreditation.
Legal basis & how it acquires force
ISO/IEC 17025 is a voluntary international standard jointly published by ISO and the IEC; it is not itself law. It becomes operative through accreditation: a national accreditation body assesses a laboratory against the standard and grants accreditation for a stated scope. The 2017 third edition is the current version, replacing the 2005 edition. Where regulators or customers require accredited testing, the requirement flows from their own rules or contracts, and ISO/IEC 17025 accreditation is the recognised means of demonstrating the laboratory’s competence.
Document structure
| Part | Covers |
|---|---|
| General requirements | Impartiality and confidentiality of the laboratory |
| Structural requirements | The laboratory’s organisation, responsibilities, and scope of activities |
| Resource requirements | Personnel, facilities and environmental conditions, equipment, metrological traceability, and externally provided products and services |
| Process requirements | Method selection and validation, sampling, handling of items, measurement uncertainty, reporting results, and complaints |
| Management system requirements | Documentation, control of records, corrective action, internal audits, and management review (Options A and B) |
Key requirements
- Demonstrated competence for each method within the accredited scope
- Metrological traceability to SI units or certified reference materials
- Method validation or verification appropriate to the method's status
- Management of risks to impartiality, and control of laboratory information systems
Implementation tips
- Read the accreditation schedule, not the certificate — the certificate tells you the laboratory is accredited, the schedule tells you for what
- Where a contract laboratory performs GMP testing, qualify it against GMP as well as accreditation, and say so in the quality agreement
- Confirm the accreditation body is an ILAC MRA signatory if the result has to be accepted in another jurisdiction
Where this control fails
live FDA enforcementLive FDA recalls SPEQ maps to this standard’s topics — a SPEQ interpretation, not an FDA classification.
International alignment
ISO/IEC 17025 is the technical basis for the ILAC Mutual Recognition Arrangement, through which accreditations are recognised across signatory economies. It complements ISO 15189 for medical laboratories and ISO/IEC 17020 for inspection bodies within the ISO/CASCO conformity-assessment family. In a GxP context it underpins the competence of contract testing and calibration laboratories that support GMP and GLP work, without replacing the GLP or GMP requirements that govern the studies or products themselves.
ISO/IEC 17025:2017: frequently asked questions
Quick answers to common questions about ISO/IEC 17025:2017.
Which edition of ISO/IEC 17025 is current?
The third edition, ISO/IEC 17025:2017, published on 30 November 2017. It replaced the 2005 second edition.
Is ISO/IEC 17025 accreditation for a whole laboratory?
No. Accreditation is granted for a defined scope and is specific per method and per matrix. A laboratory is recognised as competent for the tests and materials in its scope, not for testing in general — so the accreditation schedule matters.
Who publishes and who grants ISO/IEC 17025?
ISO and the IEC jointly publish the standard. Accreditation against it is granted by national accreditation bodies, whose recognitions are made portable through the ILAC MRA.
This standard in practice
Recall domain is a SPEQ mapping of this standard’s topics, not an FDA classification.