ISO 17025 accreditation scope on a peptide COA

ISO/IEC 17025 accreditation means an independent accreditation body has assessed a laboratory's competence for a defined list of tests. That list is its scope. Accreditation applies to the tests on the scope, not to everything the laboratory does. So when a peptide certificate comes from an accredited laboratory, the useful question is whether the specific test on the certificate is on that scope. Often it is not, and an honest certificate or supplier says so. This note explains how accreditation and scope work, how to check them, and how Alphex certificates are described. All Alphex products are for laboratory and in-vitro research only.

What ISO/IEC 17025 is

ISO/IEC 17025:2017 is the international standard for the competence of testing and calibration laboratories. It covers how a laboratory manages impartiality, staff competence, equipment, method validation, measurement uncertainty, traceability, reporting and complaints. A laboratory can follow the standard on its own, but accreditation is something else: an accreditation body assesses the laboratory against the standard and grants accreditation for named activities. ILAC, the international body for accreditation cooperation, describes accreditation as the independent evaluation of conformity assessment bodies against recognised standards. Through the ILAC Mutual Recognition Arrangement, accreditation by one signatory body, such as A2LA in the United States or UKAS in the United Kingdom, is recognised by the others.

Scope: the part most people skip

Every accreditation comes with a scope document, sometimes called a schedule. It lists the specific tests, the materials or matrices they apply to, the methods and sometimes the ranges for which the laboratory has shown competence. The accreditation certificate on its own is not enough. It has to be read together with the scope.

This matters because a laboratory can be accredited for some tests and not others. A laboratory accredited for cannabinoid potency, microbial testing or heavy metals can also run peptide HPLC under its general quality system without that HPLC test being on its accredited scope. The test may still be run competently. It has simply not been assessed by the accreditation body as part of the scope.

How to check a laboratory's scope

1. Find the accreditation body and certificate number on the certificate. If neither is there, ask for them.
2. Look the laboratory up in the body's public directory. A2LA's directory is at customer.a2la.org. UKAS has an equivalent search.
3. Open the scope document and look for the test by name and matrix, for example "peptides" or "pharmaceutical substances" with "HPLC purity" or the method reference.
4. Check the dates. Accreditation is reassessed and can lapse or change.
5. If the test is not listed, treat the result as a laboratory result under a quality system, not as an accredited result. It may still be good data, but it is a different claim. See how to verify a peptide COA with the lab.

How Alphex certificates are described

All Alphex testing is carried out by Vanguard Laboratory, Olympia, Washington, which is accredited to ISO/IEC 17025:2017 by A2LA under certificate scope 6377.01. The chromatographic purity results on Alphex certificates are not represented as accredited-scope tests. The COA library says so beside the certificates and points to A2LA Certificate 6377.01.01 for the list of accredited tests.

We state it this way because it is accurate. The value of the certificate is that an independent laboratory, not the manufacturer or Alphex, ran the analysis and issued the report with its own laboratory ID, and that the chromatogram is published. Those points are covered in testing partner independence and third-party versus in-house testing. A supplier that writes "ISO 17025 tested" on a product page without naming the scope is making a broader claim than the paperwork usually supports.

Alphex certificates report RP-HPLC chromatographic purity, and identity by comparison with a reference standard where the certificate states it. They do not cover mass spectrometry, endotoxin, water content, heavy metals or net peptide content. The exception is bacteriostatic water, which is also tested for sterility, benzyl alcohol content and pH. See reading a bacteriostatic water certificate.

What accreditation does and does not guarantee

• It does show that an accreditation body has assessed the laboratory's management system and its competence for the listed tests, including method validation and measurement uncertainty.
• It does not make a result outside the scope wrong, or a result inside the scope immune from error.
• It does not say anything about where the sample came from. Laboratories state that results relate only to the sample tested. See what that limitation means.
• It does not grade a product. Accreditation is about the laboratory, not the material it tests.

Frequently asked questions

Is a non-accredited HPLC result worthless?

No. Most peptide HPLC in research is run outside any accredited scope. What matters is that the method is suitable and documented, the chromatogram is published, and the laboratory is independent of the seller. See how to read a research peptide COA.

Why not only use an accredited peptide method?

Scope is granted test by test and method by method. Adding a new peptide method means validating it and having it reassessed, so many research peptide HPLC results are reported outside an accredited scope. What the reported figure means in practice is set out in measurement uncertainty on an HPLC purity result.

Where can I see the certificates?

In the COA library, and from the GHK-Cu and bacteriostatic water product pages.

Sources and further reading

• ILAC. About ILAC: accreditation of testing laboratories to ISO/IEC 17025 and the ILAC Mutual Recognition Arrangement
• A2LA. Directory of accredited organizations: look up a laboratory and open its scope of accreditation
• EMA. ICH Q2(R2) Validation of analytical procedures, effective 14 June 2024: what method validation for purity and identity procedures covers
• Eurachem/CITAC guide: Quantifying Uncertainty in Analytical Measurement, 3rd edition, 2012: measurement uncertainty, a core ISO/IEC 17025 requirement

Alphex research peptides are supplied for laboratory and in-vitro research by qualified researchers only. They are not authorised for human or veterinary use.

Research use only. Alphex products are supplied exclusively for laboratory and in-vitro research by qualified researchers. They are not authorised for human or veterinary use, and nothing in this note is advice on any such use.

Published 26 October 2026. Alphex reviews research notes when the testing method, the catalogue or UK guidance changes.

Alphex Research Team

Alphex Limited, UK research peptide supplier

The Alphex research team writes and maintains these notes for UK laboratories buying research peptides. Every batch Alphex lists is tested by reverse-phase HPLC (RP-HPLC) at an independent laboratory, with a batch-matched Certificate of Analysis. Content covers laboratory and in-vitro research only.