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.
Clause 7.2 requires appropriate methods and procedures, kept up to date and available to personnel. The laboratory must verify that it can properly perform methods before introducing them; where a method is non-standard, laboratory-developed or used outside its intended scope, it must be validated.
Validation evidence for a calibration method
- Uncertainty evaluation demonstrating the claimed capability.
- Comparison with a reference method or interlaboratory comparison.
- Repeatability and reproducibility studies.
- Systematic assessment of influence factors (immersion, stability, environment).
Changes to a validated method require assessment of their influence and, where they affect results, re-validation.
Frequently asked questions
- Do EURAMET calibration guides count as standard methods?
- They are widely accepted technical guidance; laboratories still verify that they can perform the method to the claimed uncertainty in their own facility.
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.
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