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.
Clause 6.4 is the equipment clause. It covers measuring instruments, software, reference standards, reference materials and consumables. Equipment must be verified to meet requirements before being placed into service, and a calibration programme must be established and reviewed to maintain confidence in calibration status.
Records the clause asks for
- Identity of the item and its software/firmware version.
- Manufacturer, model, serial number or other unique identifier.
- Evidence of verification that it meets requirements.
- Current location.
- Calibration dates, results, acceptance criteria and the date the next calibration is due (or the interval).
- Reference-material documentation.
- Maintenance plan and maintenance performed.
- Damage, malfunction, modification or repair.
When equipment is found out of tolerance, the laboratory must examine the effect on previous results and apply nonconforming-work procedures where needed.
Frequently asked questions
- Must every thermometer in the laboratory be calibrated?
- Only those whose accuracy or uncertainty affects the validity of results or that are needed for traceability. Others need to be fit for purpose, which may be shown by a simpler check.
References
- [1]ISO/IEC 17025:2017 — General requirements for the competence of testing and calibration laboratories
General technical guidance written against the cited sources. It is not regulatory or legal advice and does not replace the applicable standard, guideline or a qualified reviewer's judgement.
Have a question on this topic?
Ask ValiTrac AI and see the evidence and calculation behind the answer.
Ask ValiTrac AIFree calculator: Guard band / decision rule
Turn a tolerance and an expanded uncertainty into acceptance limits under ILAC-G8 rules, and see the false-accept and false-reject risks.
Open the calculatorCalibration on ValiTrac
Support calibration workflows, uncertainty budgets and certificate generation.
See the calibration workflowRelated articles
How to set calibration intervals
There is no universal interval. Set it from risk, manufacturer data and — above all — the instrument's own as-found history.
Metrological traceability in ISO/IEC 17025 (clause 6.5)
Results must be traceable to the SI through calibration by a competent laboratory, certified values of certified reference materials, or direct realisation of SI units.