What a laboratory’s ISO 17025 accreditation actually covers

Certificates of analysis tend to carry logos and phrases meant to signal quality: "ISO 17025 accredited," "cGMP," "FDA registered," "ISO certified." They sound interchangeable. They aren't, and only one of them says anything about whether the laboratory is competent to run the particular test on the report in front of you.

The short answer: accreditation to ISO/IEC 17025 is granted test by test, not to a laboratory as a whole. The list of tests it covers is called the scope, the scope is public, and whether the result you're reading falls inside it is something you can check yourself.

What ISO/IEC 17025 accreditation means

ISO/IEC 17025 is the international standard for the competence of testing and calibration laboratories. A laboratory is accredited to it by an accreditation body, after an assessment of its methods, staff, equipment and quality system. In the United States, A2LA and ANAB are two of the main accreditation bodies. Internationally, bodies that have signed the ILAC mutual recognition arrangement recognize one another's accreditations.

The key word is scope. Accreditation is never granted for "testing" in general. It is granted for a defined list: a particular measurement, by a particular method, on a particular kind of material. That list is the laboratory's scope of accreditation, and the accreditation body publishes it.

An accredited laboratory versus an accredited result

This is where most of the confusion starts. A laboratory can be accredited, entirely legitimately, for heavy metals in dietary supplements, and not accredited for peptide purity by HPLC at all. The accreditation is real. It just doesn't cover the number you're reading.

So there are two statements that look alike and aren't:

• "This is an accredited laboratory." Some of what the facility does falls within an accreditation scope.
• "This is an accredited result." The specific test on this report falls within that scope.

Only the second tells you something about the number on the page. Many accredited laboratories mark on the report which results are within their accreditation and which aren't. When the report doesn't say, the scope document will.

Labels that are not the same thing

• ISO 9001 certifies an organization's quality management system. It says processes are documented and followed. It is not an assessment of technical competence to run any particular test.
• GMP or cGMP is good manufacturing practice, and it applies to manufacturing. On a testing report it usually refers to someone else's facility, or is simply self-declared.
• "FDA registered" means a facility is on a list. Registration is not approval and not endorsement, and the FDA says so itself.
• CLIA certifies laboratories that test human specimens for diagnosis. It has nothing to do with analyzing a product.
• "ISO certified," with nothing else, is too vague to mean anything until you know which standard, which body and which scope.

How to check an accreditation in about five minutes

1. Find the accreditation body and the certificate number, on the report or on the laboratory's own site.
2. Look the laboratory up in that body's public directory. Don't rely on a PDF the laboratory or the seller supplies.
3. Open the scope document.
4. Find the test on your report: the measurement, the method and the type of material.
5. Check that the accreditation is current, not expired, withdrawn or suspended.
6. Check that the name and address in the directory match the report.

If the test on your report isn't in the scope, the result isn't accredited, whatever the logo at the top says.

Unaccredited isn't the same as wrong

A great deal of good analytical work is done by laboratories that aren't accredited for a given test, and some of the tests used on research peptides fall outside most laboratories' scopes. What matters is that the status is stated accurately. A laboratory that says precisely what its accreditation covers is more trustworthy, not less, than one that lets a logo imply more.

Accreditation bodies also set rules on how their logos may be used. An accreditation logo on a report of a test outside the laboratory's scope is a small red flag, and worth noticing.

What accreditation can't tell you

An accredited result tells you a measurement was made competently. It doesn't say the product is suitable for any use, and it doesn't say the sample tested has anything to do with the vial you hold. That second question is the subject of why an unmarked peptide vial means a certificate can describe anything.