ISO/IEC 17025 is the international standard that testing and calibration laboratories are accredited against to show they work competently and impartially and produce valid results. The current edition is ISO/IEC 17025:2017, which ISO last reviewed and confirmed in 2023, and there is no 2025 edition.
This guide is for quality and technical managers in commercial testing, calibration and in-house laboratories.
Is ISO/IEC 17025:2017 still the current edition?
Yes. The third edition was published in November 2017 and replaced ISO/IEC 17025:2005.
ISO's page for the standard shows it completed a systematic review in August 2023 with the decision to confirm it. The same page lists no revision project. Claims about an "ISO 17025:2025" refer to nothing ISO has published, so check the cover page of any copy or course you buy.
The move from the 2005 edition is long finished. ILAC first set 30 November 2020 as the end of the transition, then extended it to 1 June 2021 because of COVID-19. After that date, accreditation to the 2005 edition was no longer recognised under the ILAC arrangement.
One institutional change is recent. On 1 January 2026, ILAC and the International Accreditation Forum (IAF) were replaced by a single body, Global Accreditation Cooperation Incorporated (Global ACI), with its own recognition arrangement. Accreditations recognised under the ILAC arrangement continue to be recognised during the move, and the standard itself did not change.
What does ISO/IEC 17025 require, clause by clause?
The requirements sit in clauses 4 to 8. Clauses 4 to 7 cover impartiality, structure, resources and the testing or calibration process.
Clause 8 covers the management system and offers two options. Option A sets out the management system clauses in full. Option B lets a laboratory that already runs a system in line with ISO 9001 use it, provided it supports clauses 4 to 7.
The table shows each group and the records assessors usually ask to see. The records column is AGS's interpretation, not the standard's wording.
| Clause | What it covers | Records assessors usually ask for |
|---|---|---|
| 4.1 and 4.2 | Impartiality and confidentiality | Impartiality risk register, signed confidentiality agreements |
| 5 | Legal identity, management structure, range of laboratory activities | Organisation chart, defined scope of activities, job descriptions |
| 6.2 to 6.4 | Personnel, facilities and environmental conditions, equipment | Competence and authorisation records, environmental monitoring logs, equipment history cards |
| 6.5 and 6.6 | Metrological traceability, externally provided products and services | Calibration certificates, approved external provider list |
| 7.1 to 7.5 | Contract review, methods, sampling, handling of items, technical records | Contract review records, method verification and validation reports, worksheets |
| 7.6 to 7.8 | Measurement uncertainty, validity of results, reporting | Uncertainty budgets, quality control charts, proficiency testing results, report checks |
| 7.9 to 7.11 | Complaints, nonconforming work, data and information management | Complaint log, nonconforming work reports, software validation records |
| 8 | Management system, Option A or Option B | Internal audit reports, management review minutes, corrective actions |
ISO lists three main changes from 2005 in the foreword. Risk-based thinking replaced some prescriptive rules with performance-based ones. Processes, procedures and documented information became more flexible. A definition of "laboratory" was added.
How does the standard apply to testing, calibration and in-house laboratories?
The same clauses apply to every laboratory, whatever its size. What assessors focus on depends on what the laboratory does.
A calibration laboratory is judged first on its traceability chain and its uncertainty statements. Clause 6.5 covers traceability and clause 7.8.4 sets specific requirements for calibration certificates. ILAC's policies P10:07/2020 on traceability and P14:09/2020 on uncertainty in calibration are what accreditation bodies apply here.
A commercial testing laboratory often issues pass or fail statements against a specification. Clause 7.8.6 covers those statements of conformity. You agree a decision rule with the customer that says how measurement uncertainty is taken into account. ILAC G8:09/2019 is the guidance most bodies point to.
An in-house laboratory inside a factory faces a different risk. Production may want a batch released, and the laboratory reports to the same management. Clause 4.1 expects you to identify that pressure as an impartiality risk and show how you manage it.
Laboratories that take samples on site, such as environmental testers sampling water, air or stack emissions, also meet clause 7.3 on sampling and clause 7.8.5 on reporting sampling.
How does accreditation work, and what is a scope of accreditation?
Laboratories are accredited, not certified, against ISO/IEC 17025. A national accreditation body assesses technical competence as well as the management system. In the UAE, the Emirates International Accreditation Centre (EIAC) accredits testing, calibration and medical laboratories. The GCC Accreditation Center (GAC) accredits testing laboratories to ISO/IEC 17025:2017.
The process usually runs from application and document review to an on-site assessment. Technical assessors watch staff perform tests or calibrations and trace results back through the records. The laboratory then closes any findings before the accreditation decision. Surveillance visits follow, and each body sets its own cycle and fees.
Accreditation never covers the whole laboratory by default. It covers a scope of accreditation, which lists the specific tests or calibrations, methods, materials and ranges assessed. A test outside the scope cannot be reported as accredited, so define the scope before you write procedures.
How often must a laboratory take part in proficiency testing?
Clause 7.7 requires a laboratory to monitor the validity of its results, including by comparison with other laboratories where available. ILAC P9:01/2024 sets the accreditation bodies' policy. It cites clause 7.7.2 and expects laboratories to plan the level and frequency of participation according to risk.
In practice, assessors look for a multi-year plan that covers each major area of the scope, the results, and the action taken on any unsatisfactory result. Our guide to ISO/IEC 17043:2023 explains how proficiency testing providers are run and how to choose one.
How is GLP different from ISO/IEC 17025, and where does ISO 15189 fit?
GLP and ISO/IEC 17025 answer different questions. The OECD Principles of Good Laboratory Practice, as revised in 1997, apply to non-clinical safety studies. These cover test items in pharmaceuticals, pesticides, cosmetics, veterinary drugs, food and feed additives and industrial chemicals, according to the OECD Council decision. In the United States, 21 CFR Part 58 sets GLP for non-clinical studies that support FDA applications.
GLP is built around the individual study. It requires a study director with overall responsibility, a study plan, a quality assurance programme independent of the study, and archived records. Compliance is verified by government GLP monitoring programmes through inspections, not by accreditation.
ISO/IEC 17025, by contrast, accredits a laboratory's competence for routine tests and calibrations. A laboratory that runs regulatory safety studies and routine testing may need both.
Medical laboratories use a different standard. ISO 15189:2022, published in December 2022, covers quality and competence in medical laboratories. Our ISO 15189 guide covers it.
A calibration or industrial testing laboratory is accredited to ISO/IEC 17025, not ISO 15189. Other conformity assessment standards are listed in our Quality, Excellence and Accreditation collection.
How AGS can help
Two AGS kits cover this topic. Both contain editable Microsoft Word files.
- ISO/IEC 17025:2017 Management System: 128 documents, including a quality manual, 21 procedures, 75 forms and records, a gap-analysis checklist and templates for environmental testing.
- IMS Commercial Testing & Calibration Laboratories (GLP, ISO/IEC 17025, ISO 15189, ISO 9001): 75 documents, including an integrated manual, a standards cross-reference matrix and 24 procedures.
Frequently asked questions
Does an ISO 9001 certificate make a laboratory compliant with ISO/IEC 17025?
No. ISO 9001 covers the management system only. ISO/IEC 17025 adds technical requirements such as method validation, traceability and measurement uncertainty, which an accreditation body assesses.
Can a laboratory be accredited for only some of its tests?
Yes. Accreditation covers the tests or calibrations listed in the scope, and a laboratory can apply to extend the scope later.
Do accreditations recognised under the ILAC arrangement still count after the move to Global ACI?
Yes. Global ACI states that accreditations recognised under the ILAC arrangement continue to be recognised during the transition to its own arrangement.
Does buying documentation mean the laboratory will be accredited?
No. Documents are a starting point. Accreditation depends on how the system is implemented and on the accreditation body's assessment.
AGS provides independent documentation toolkits. This guide and the referenced kits are not affiliated with, endorsed by or approved by ISO, IEC, ILAC, Global ACI, the OECD, EIAC, GAC or any other accreditation body. They do not guarantee any assessment or accreditation outcome.
Reviewed October 2026. Facts checked against the sources current at publication.
