Quality
ISO/IEC 17025:2017 — Competence of testing and calibration laboratories
The accreditation standard for testing and calibration laboratories: demonstrate your technical competence and the reliability of your results.
At a glance
- Type
- International standard, accreditation basis
- Publishers
- ISO and IEC (ISO/CASCO committee)
- Edition
- 2017 (3rd edition)
- Accreditation
- COFRAC in France, for a defined scope
141 requirements tracked · 93 shared controls
What is ISO/IEC 17025?
ISO/IEC 17025 sets out the general requirements for the competence, impartiality and consistent operation of testing and calibration laboratories, including when they perform the associated sampling. It is the standard against which national accreditation bodies assess laboratories: in France, COFRAC (Comité français d’accréditation).
The 2017 edition groups its requirements into five clauses: general requirements (impartiality, confidentiality), structural, resource, process and management system requirements. It adopts risk-based thinking and offers two management system options: Option A, described in the standard, or Option B, based on a system that conforms to ISO 9001.
Accreditation recognises the laboratory’s technical competence for a precise scope (tests or calibrations, methods, items, measurement ranges): it goes further than an ISO 9001 certification, which only covers the management system. European and international recognition arrangements (EA, ILAC) make reports issued under accreditation easier to accept abroad.
Key requirements
- 1
Impartiality and confidentiality
Identify risks to impartiality on an ongoing basis (financial links, commercial pressure, conflicts of interest) and control them; protect customer information, with a commitment from all personnel.
- 2
Structure and responsibilities
A legally responsible entity, identified management, a defined range of activities and documented responsibilities, including for technical decisions.
- 3
Competent and authorised personnel
Define competence requirements per function, train and supervise, then authorise each person for the activities they perform and monitor their competence over time.
- 4
Facilities, equipment and metrological traceability
Control environmental conditions, calibrate and check equipment according to a programme, and relate results to SI units through an unbroken chain of calibrations.
- 5
Methods, sampling and measurement uncertainty
Select appropriate methods, verify standard methods and validate the others, plan sampling and evaluate measurement uncertainty.
- 6
Validity of results and reporting
Monitor the validity of results (internal quality control, proficiency testing, interlaboratory comparisons), review requests and issue accurate reports, with a decision rule whenever conformity is stated.
- 7
Nonconforming work, data and management system
Handle nonconforming work and complaints, control data and laboratory information systems, and keep the management system alive (Option A or B): documents, risks, internal audits, management review.
Summary written by OK-GRC. The texts of ISO standards are protected by copyright and are not reproduced.
How OK-GRC helps
- The 141 requirements of clauses 4 to 8 linked to 93 common controls, including 21 laboratory-specific controls (calibration, uncertainty, proficiency testing, decision rules…)
- Six bilingual templates: laboratory quality manual, impartiality and confidentiality, equipment and metrological traceability, method validation and uncertainty, review of requests and reporting, validity of results
- Options A and B tracked as requirements: the option not chosen is excluded with its justification, without distorting the score
- A ready-made accreditation programme in the Programme management module: target scope, COFRAC application, assessment, decision and surveillance, with milestones and automatically checked deliverables
- Dated evidence (calibration certificates, proficiency testing results) with reminders before expiry
- Internal audits, management review, nonconforming work and corrective actions linked to the requirements
Related frameworks
With ISO 27001 controls in place, your ISO/IEC 17025 starting score is about 26 to 29%.
With an ISO 9001 quality management system in place, your ISO/IEC 17025 starting score is about 31 to 41%.
The controls you put in place for ISO/IEC 17025 also count for:
- ISO 9001Option B: an ISO 9001 QMS already covers, at least partly, 23 to 24 of the 25 requirements of clause 8 (starting score of about 73 to 80% on that clause). The technical clauses 6 and 7 remain to be built.
- ISO 27001Confidentiality of customer information (4.2) and control of data and laboratory information systems (7.11) rely on your information security controls.
Frequently asked questions about ISO/IEC 17025
ISO/IEC 17025 accreditation or ISO 9001 certification: what is the difference?
ISO 9001 certification attests that your management system conforms; it is issued by a certification body. ISO/IEC 17025 accreditation also recognises your technical competence for a precise scope of tests or calibrations; it is granted by the national accreditation body (COFRAC in France) after an assessment carried out with technical assessors from the field. An ISO 9001 certification is therefore not an accreditation.
We are already ISO 9001 certified: what is left to do?
Your QMS can serve as the foundation (Option B): it covers, at least partly, 23 to 24 of the 25 requirements of clause 8. Across the whole standard, the starting score remains about 31 to 41%: most of the work concerns impartiality, staff competence and authorisation, equipment and metrological traceability, method validation, measurement uncertainty, validity of results and reporting.
How does COFRAC accreditation work?
The laboratory defines the target scope, implements the standard and the COFRAC requirements (in particular LAB REF 02), builds up records, then submits its application. After the admissibility review, a team made of a lead (quality) assessor and technical assessors carries out the on-site assessment; the findings are handled through an action plan before the accreditation decision. Accreditation is then maintained through surveillance assessments and renewed at each cycle: check the current arrangements with COFRAC.
Are medical laboratories concerned?
No. In France, medical biology laboratories are accredited against NF EN ISO 15189, a standard specific to the medical field that OK-GRC does not include at this stage. ISO/IEC 17025 is for testing and calibration laboratories.
Informational content up to date as of October 2026; it does not constitute legal advice. Always check the official texts in force.
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