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ISO/IEC 17025 lab accreditation: what it signals

AuraVia Research-team4 min leestijd

GMP auditing covers how a compound is manufactured. ISO/IEC 17025 accreditation covers something different but equally relevant: whether the lab that tested the finished batch is itself competent to produce a reliable result. The two standards answer separate questions, and a supplier's documentation is stronger when it can speak to both.

What the standard actually assesses

ISO/IEC 17025 is the general international standard for the competence of testing and calibration laboratories. Accreditation against it means an independent accreditation body has assessed the lab's technical competence, its equipment calibration and maintenance records, its staff qualifications, and its quality management system — not just reviewed a sample report.

Crucially, it's assessed method by method: a lab can hold accreditation for specific test types rather than blanket accreditation for everything it offers, which is why it's worth checking that the accreditation actually covers the test being relied on (such as HPLC purity analysis) rather than assuming a lab's accreditation is universal.

How it complements GMP

GMP auditing and ISO 17025 accreditation sit on either side of the same supply chain: GMP is about the discipline behind how a batch was made, while 17025 is about whether the lab result describing that batch can itself be trusted. A well-documented supplier chain generally has some form of both — controlled manufacturing and competently assessed testing — rather than relying on just one.

What to ask for

A lab confident in its accreditation status will generally cite its accreditation body and scope directly, or make that information available on request, rather than relying on general assurances of accuracy. That specificity is itself a useful signal when comparing suppliers.

Dit artikel is algemeen naslagmateriaal voor onderzoeksgebruik en vormt geen doserings-, medisch of klinisch advies. Productspecifieke kwaliteitsdocumentatie is beschikbaar op elke productpagina en via onze batchverificatietool.

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