ISO/IEC 17025
What the laboratory-competence standard asks for and why.
ISO/IEC 17025 calibration explained
What accreditation to ISO/IEC 17025 does and does not tell you about a calibration.
ISO/IEC 17025:2017 structure: what each clause covers
The 2017 edition is organised into general, structural, resource, process and management-system requirements. Knowing the map makes the standard usable.
Impartiality and confidentiality under ISO/IEC 17025
The 2017 edition made impartiality a first-class requirement: laboratories must identify risks to it on an ongoing basis and show how they are managed.
Personnel competence records under ISO/IEC 17025
Competence must be defined, achieved, authorised and monitored — with records for each step, for every activity that affects results.
Equipment requirements in ISO/IEC 17025 (clause 6.4)
Equipment must be fit for purpose, calibrated where it affects results, checked, protected from adjustment, and fully recorded — including software.
Metrological traceability in ISO/IEC 17025 (clause 6.5)
Results must be traceable to the SI through a competent laboratory's calibration, the certified value of a reference material, or direct realisation.
Method selection, verification and validation (clause 7.2)
Standard methods must be verified before use; non-standard or modified methods must be validated. The extent depends on the intended use.
Evaluation of measurement uncertainty (clause 7.6)
Laboratories must identify the contributions to uncertainty and, for calibration, evaluate the uncertainty of every result — their own equipment included.
Reporting results and statements of conformity (clause 7.8)
A certificate must carry defined identification, method, traceability and uncertainty information — and any pass/fail statement must name the decision rule.
Nonconforming work under ISO/IEC 17025 (clause 7.10)
An out-of-tolerance reference, a failed data-quality check or a wrong method must be controlled, evaluated for impact on results issued, and recorded.
Technical records: what to keep and for how long (clause 7.5)
Records must let the measurement be repeated under conditions as close as possible to the original, and every amendment must show who changed what, when.
Internal audits and management review (clauses 8.8 and 8.9)
Internal audits check the system against the standard and your own procedures; management review asks whether it is still suitable, adequate and effective.