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ISO/IEC 17025 Explained: What Lab Accreditation Covers

Botanical Blends — kratom-free botanical supplement brands

ISO/IEC 17025 is the international standard for the technical competence of testing and calibration laboratories, and accreditation to it means an independent accreditation body has assessed a laboratory against that standard and signed off. What almost every buyer gets wrong is the unit of measurement: accreditation is granted method by method, not to the building. A laboratory can hold entirely genuine accreditation and still print results on the same certificate that fall outside its accredited scope.

Those results are disclosed. They are disclosed in footnotes, marked with asterisks, at the bottom of the page, in small type. This article is about learning to read that part of the document, using a real cat's claw certificate that flags its own MGM-15 method as non-accredited.

What the standard actually covers

ISO/IEC 17025 is published jointly by the International Organization for Standardization and the International Electrotechnical Commission. The current edition dates from 2017. It sets requirements in a few broad areas:

  • Impartiality and structure — the laboratory must identify and manage risks to its independence, and commercial pressure must not bear on results.
  • Resources — competence of personnel, suitability of equipment, and metrological traceability, meaning instruments are calibrated against recognised references rather than against themselves.
  • Process — method selection and validation, sampling, handling of test items, evaluation of measurement uncertainty, and the content of reports.
  • Management system — documentation, control of records, internal audit, corrective action, and handling of nonconforming work.

Two of those separate an accredited result from a merely plausible one. Method validation means the laboratory has demonstrated that a procedure produces reliable results for a particular analyte in a particular matrix — a compound in a chewable tablet is not the same analytical problem as the same compound in a powder. Measurement uncertainty means the laboratory can state how confident it is in the number, which is why a credible report carries detection and quantitation limits rather than bare results.

What an accreditation body does

An accreditation body is a third party to the third party. It does not test anything. It assesses laboratories, on site, against the standard, and grants accreditation for a defined list of work.

In the United States the recognised bodies include the ANSI National Accreditation Board, A2LA, and Perry Johnson Laboratory Accreditation. Assessment normally involves a document review, an on-site visit by technical assessors who watch analysts perform methods, review of quality records, and proficiency testing — blind samples of known composition sent to many laboratories and the results compared. Accreditation is maintained through periodic reassessment rather than granted once and kept.

Most of these bodies are signatories to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement, which is what the ilac-MRA mark on a certificate refers to, and why an accreditation granted in one country is recognised in others.

What an accreditation body does not do is vouch for any particular result, approve a product, or take a position on whether a product is safe or lawful. It attests to competence within a scope.

Scope is the document nobody reads

Every accredited laboratory has a scope of accreditation: a published document, usually a few pages, listing the specific test methods, matrices, and measurement ranges the accreditation covers. It is held by the accreditation body, not the laboratory, and it is normally searchable on the body's public directory by certificate number.

This is the single most useful thing in this article. If a certificate names its accreditation body and certificate number, you can look up the scope yourself and see whether the method used on your product appears on it. Most people never do. Almost nobody in this category does.

Anything not on that list is not accredited work, even when it is performed by the same analysts on the same instruments in the same room. A laboratory may be excellent at a method it has never submitted for assessment. Accreditation simply does not speak to it.

The catch, in a real document

Here is the case that made us write this. We reviewed BLACK, a cat's claw tablet brand, as a sourcing candidate. We did not list it, for reasons set out in our full review of the product and its paperwork. But its certificate is the clearest teaching example we have found, precisely because it is unusually honest.

The report was issued by NN Analytics of San Diego for batch B260216-7, sample ID 2602-352, received and analysed on February 16, 2026, and digitally signed the following day by a named analyst and a named reviewer. The page carries the ilac-MRA mark and the ANAB accredited-testing-laboratory mark. All of that is real.

The document contains two separate alkaloid method groups:

Method group Method Detection limits stated? Accredited?
Cat's Claw Alkaloids (WKI-03-0107) HPLC with diode-array detection; analysis dated Yes — LOD 0.125 mg/g, LOQ 0.2604 mg/g on every line Not flagged
Kratom Alkaloids (WKI-03-0119) GC/MS, analysis date printed as "TBD" No — LOD and LOQ both printed "N/A" on every line Flagged non-accredited by the certificate's own footnote

The second group is where MGM-15 appears. Every analyte in it carries a double asterisk, and the footnote at the foot of the page explains what the asterisk means: those methods were validated by NN Analytics "but not by ANAB, and is therefore not an ISO17025 accredited work item." A second footnote names Dihydro-7-hydroxy Mitragynine — MGM-15 — explicitly.

So the certificate reports MGM-15 as not detected, and in the same breath tells you that the method producing that result sits outside the laboratory's accredited scope, has no stated detection limit, and carries no analysis date. The laboratory disclosed all three things. It behaved well. The disclosure is simply in six-point type under two signatures, where nobody looks.

Non-accredited does not mean wrong

It is worth being fair about what that footnote does and does not imply.

An in-house-validated method can be perfectly sound. Laboratories routinely develop methods for new analytes ahead of accreditation, because accreditation is slow and expensive and the compounds in this category are moving faster than assessment cycles. MGM-15 is a recent regulatory concern; there is no long-established accredited method sitting on a shelf waiting for it. A laboratory that develops one and says plainly that it is not yet accredited is doing the right thing.

What the footnote does mean is that nobody outside that laboratory has checked the method. There is no external assessment of its validation, no proficiency-testing comparison against other laboratories, and — on this document — no stated limit of detection, so a reader cannot tell what threshold "not detected" sits above. As we cover in what non-detect actually means, a non-detect without a detection limit is not an interpretable result.

That is why a non-accredited non-detect cannot carry a marketing claim. It is evidence of good faith. It is not evidence a buyer can rely on, and it is nowhere near enough to support a sentence like "contains no MGM-15" on a product page.

How to read the footnotes

The disclosures are formulaic once you know the shapes. Look at the bottom of the page, and at any asterisk, dagger, or superscript beside a method name or analyte.

What the footnote says What it means
Method validated in-house / by the laboratory, but not by the accreditation body The result is real but externally unverified. Not an accredited work item.
Not included in the laboratory's scope of accreditation Same thing, stated directly.
Results marked with an asterisk were obtained by non-accredited methods Go back and check which lines carry the mark. It is often the ones that matter most.
Subcontracted to another laboratory Someone else ran it. Their accreditation status is a separate question, and the report may not answer it.
Sampling performed by the client The laboratory did not draw the sample and takes no responsibility for whether it represents the lot.
Opinions and interpretations are outside the scope of accreditation Any conclusion the report draws beyond the raw numbers is not accredited work.
Results relate only to the items tested Standard and correct. It is also a reminder that the report is about one sample, not a product line.

A practical rule: read the footnotes before the results. If the compound you care about turns out to be footnoted, the number above it means less than it appears to. The rest of the document-reading routine is in our guide to reading a certificate of analysis.

What accreditation never covers

  • The sample. Accreditation says nothing about whether what arrived at the laboratory represents the lot you are buying.
  • Analytes nobody ran. An accredited method for one compound tells you nothing about a compound absent from the panel — the point we make at length in what third-party testing actually proves.
  • Panels marked "not tested." On the BLACK document the heavy metals, residual solvents, and microbial sections are all marked NT with dates listed as TBD. Those rows are printed, but nothing was run.
  • The label. A laboratory tests what it is sent. It does not audit whether the ingredient deck on the box reconciles with the tablet.
  • Legality. No accreditation body has a view on whether a product may lawfully be sold in your state.

Where this leaves our own claims

We will not use an accreditation mark as a substitute for reading a panel, including on our own paperwork. The supplier certificates we hold report non-detect for seven analytes: 7-hydroxymitragynine, mitragynine, speciociliatine, speciogynine, paynantheine, corynantheidine, and mitraphylline. That supports three statements about the products we carry — no kratom, no mitragynine, no 7-OH — and nothing further.

Those panels do not cover mitragynine pseudoindoxyl, MGM-15, MGM-16, or corynoxine B. Every compound named, with no threshold at all, in the DEA's second Notice of Intent — published in the Federal Register on July 6, 2026 as FR Doc 2026-13581 — is a compound our panels never looked for. We explain what those substances are in MGM-15 and MGM-16 explained. Until we hold an independent, accredited panel covering them, we will not write "no MGM" or "free of scheduled compounds," and we would rather publish the gap than fill it with an accreditation logo. Everything we hold is on our certificate of analysis page, footnotes included.

Frequently Asked Questions

Does ISO/IEC 17025 accreditation mean a product is safe or approved?

No. It speaks to the competence of the laboratory within a defined scope of methods. It is not a product approval, not a safety finding, and not an opinion on the result. A perfectly accredited laboratory can report a failing number.

How can I check whether a specific method was accredited?

Two ways. Read the footnotes and asterisks on the certificate, which is where laboratories disclose non-accredited work. Then look up the laboratory's published scope of accreditation on its accreditation body's public directory, using the certificate number printed on the report, and check whether the method appears.

Is a non-accredited result worthless?

No, but it is weaker, and how much weaker depends on what else is missing. A non-accredited method with a stated detection limit, a real analysis date, and a named analyst is meaningful supporting data. One with no detection limit and no analysis date is not something anyone should build a claim on.

Why would a laboratory run a non-accredited method at all?

Usually because the analyte is new. Accreditation for a method takes time and money, and regulatory attention in this category has moved faster than assessment cycles. Developing a method, validating it internally, and disclosing its status on the report is the honest way to handle that gap.

These statements have not been evaluated by the Food and Drug Administration. These products are not intended to diagnose, treat, cure, or prevent any disease. For adults 21+. Legality depends on the specific formulation and applicable state law — check the rules where you live. Nothing here is legal advice.