A purchasing coordinator is assembling a supplier qualification file for a new research peptide. The analytical report attached to the product carries an accreditation body’s logo in the header, and below it sit two results: an HPLC purity figure and a mass spectrometry identity result. The coordinator’s manager asks a simple question: are both results accredited? The logo alone cannot answer that. The answer depends on the laboratory’s scope, and it can be checked in a few minutes without contacting anyone.
What the standard is
ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories; its current edition was published in 2017. A laboratory does not certify itself. It is assessed by an accreditation body, and if it meets the standard for particular activities, it is accredited for those activities.
Assessment covers two areas together. One is technical competence to perform specific methods. The other is the management system that surrounds that work. In practice, an accredited laboratory has demonstrated that, for the methods in its scope:
- its instruments are calibrated with traceability to recognized references;
- its staff are trained and their competence is documented;
- its methods are validated or verified for their intended use;
- its results can be accompanied by an estimate of measurement uncertainty;
- it takes part in proficiency testing or comparable checks against other laboratories.
Why those elements matter to a buyer
Two of those elements are especially useful when reading a result. Proficiency testing means the laboratory periodically analyzes samples also sent to other laboratories and has its answers compared with theirs; a laboratory that drifts away from its peers is likely to be noticed. Measurement uncertainty means the laboratory has estimated how far a reported value could plausibly differ from the true value. Together they turn a single number into something closer to a range with known reliability. A purity reported as 98.6 percent from an accredited method is not more accurate by virtue of the logo, but the laboratory has had to show evidence about how accurate that kind of figure is likely to be.
Accreditation is always for a scope
No laboratory is accredited in general. What is granted is a scope of accreditation: a list of specific tests, on specific types of material, often over stated ranges. A laboratory accredited for HPLC purity of synthetic peptides is accredited for that. The same laboratory may also run mass spectrometry, elemental analysis or other tests that are not in its scope. Those results are not accredited simply because they appear on the same letterhead.
That is exactly the situation in the opening example. If the laboratory’s scope lists chromatographic purity only, the HPLC figure may be an accredited result and the mass spectrometry result is not, even though a genuine logo sits above both. Nothing on the report is false; the logo just covers less than it appears to.
Checking a claim in three steps
- Find the identifiers. Locate the accreditation body’s name and the laboratory’s certificate or accreditation number on the report.
- Look up the laboratory. Accreditation bodies maintain public directories of the laboratories they accredit. Confirm that the named laboratory appears and that its accreditation is current.
- Read the scope. Open the scope document attached to that listing and confirm that the method behind the result you care about appears on it, for the kind of material tested.
If all three check out, the specific result was produced under an accredited method. If the method is absent from the scope, the result may still be good work, but it is not an accredited result.
What the logo does not mean
| Common assumption | What accreditation actually supports |
|---|---|
| The vial I received was tested | The laboratory reports on the sample it was given. Accreditation does not extend the report to other material. |
| Every result on the report is accredited | Only results from methods within the published scope. |
| The peptide is ISO 17025 certified | Accreditation belongs to the laboratory, not to any substance it tests. |
| It is equivalent to manufacturing standards | Good Manufacturing Practice governs how material is made; ISO/IEC 17025 governs how testing is done. They answer different questions. |
| A purity result covers everything | A purity figure measures purity. Other properties need their own tests. |
The first row deserves attention. A laboratory, accredited or not, can only speak to the sample in front of it. How that sample was chosen and how it relates to the product supplied are separate questions, discussed in what third-party tested means.
When no accreditation can be traced
A report may name no laboratory, or name one that does not appear in any accreditation directory. That is a different claim, not proof of poor work. Much competent analytical testing happens outside accredited scopes. It should simply be weighed as what it is, rather than as what the word “accredited” might suggest. The rest of what a report can and cannot show is covered in reading a peptide certificate of analysis.
For the qualification file, the useful approach is to record exactly what was verified: the accreditation body, the laboratory, the certificate number, the date checked, and whether the relevant method appears in scope. The structure of such a file is set out in building a supplier qualification file.
Battle Born has each product analyzed by independent reverse-phase HPLC and publishes the result for that product. Testing is per product rather than per production batch, and a vial is matched to its published test by crimp and cap color. As with any report, the scope of what was tested is the thing to read.
Questions
Does an accreditation logo mean every result on the report is accredited?
No. Only results from methods listed in the laboratory’s scope of accreditation are accredited, even if other results appear on the same document.
Can a peptide be ISO 17025 certified?
No. The standard applies to laboratories. A substance tested by an accredited laboratory is not itself certified.
How do I verify a laboratory’s accreditation?
Use the accreditation body and certificate number on the report to find the laboratory in the body’s public directory, then read its scope for the method in question.
Is unaccredited testing unreliable?
Not necessarily. It has not been independently assessed for that method, which is a narrower statement. Judge it on the evidence the report provides.
Research use only. All products supplied by Battle Born Peptides are laboratory reference materials for in-vitro research and analytical use by qualified professionals. They are not drugs, foods, dietary supplements, cosmetics or medical devices; they are not approved by the FDA or any other regulator for use in humans or animals; and they are not intended to diagnose, treat, cure, mitigate or prevent any disease, or to affect the structure or any function of the body of humans or animals. Nothing in this article is preparation, handling or dosing guidance. See our full research-use terms.