A laboratory’s ISO 17025 accreditation scope is one of the most information-dense documents in the TIC industry — and one of the most underused. Most manufacturers verify that a lab is accredited and stop there. The scope document is what tells you whether that accreditation is actually relevant to your testing needs.
Reading a scope document correctly takes some practice. The format varies by accreditation body, and the terminology can be dense. But the core information you need is always there: which tests are covered, which methods are used, and which matrices the accreditation applies to. Here’s how to find it and what to do with it.
Scope documents are public records maintained by accreditation bodies. You should always download the scope directly from the accreditation body’s website — not from the laboratory’s own materials. Labs sometimes post outdated scope documents, or scope documents that have been modified from the official version.
In the United States, the three major accreditation bodies for testing laboratories are:
Each lab has a unique certificate number. If a lab provides you with their accreditation certificate, the certificate number is on it. Use that number to pull the current scope directly from the accreditation body’s database. This confirms the certificate is current and that the scope you’re reviewing is the official, up-to-date version.
Scope documents from A2LA and PJLA typically follow a similar structure, though the exact format varies. The key fields in each scope entry are:
Test/Property: What is being measured or evaluated. This might be “Microbial Enumeration,” “Lead by ICP-MS,” “Potency by HPLC,” or “Moisture Content.” The specificity varies — some scope entries are broad, some are very specific.
Method: The specific method used for the test. This is one of the most important fields. The method reference tells you which version of which standard the lab is accredited to run. For example, “USP <61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests (2023)” tells you the lab is accredited for the current USP chapter, not an older version. If the method reference is to an older standard version, ask the lab whether they’ve updated their procedures.
Matrix: The type of sample the accreditation covers. This is where many manufacturers miss critical information. A lab might be accredited for lead testing by ICP-MS in “food products” but not in “dietary supplements” — and those are different matrices with different sample preparation requirements. Always confirm the matrix in the scope matches your product type.
Range/Limit: Some scope documents include the measurement range or detection limit for quantitative tests. This tells you whether the lab’s accredited capability covers the concentration range relevant to your specifications.
Some laboratories hold what’s called a “flexible scope” accreditation for certain test categories. A flexible scope allows the lab to add new tests or matrices within a defined category without seeking individual approval for each addition, as long as the new tests use the same general methodology and the lab demonstrates competence.
Flexible scope accreditation is legitimate and common, particularly for laboratories that run a large number of analytes by methods like ICP-MS (for elemental analysis) or GC-MS (for pesticide residues). But it requires a different verification approach. For a fixed scope, you can confirm a specific test is listed. For a flexible scope, you need to ask the lab directly whether the specific test and matrix you need falls within their flexible scope, and ask for documentation of their competence for that specific application.
Beyond the specific tests listed, a scope document tells you something about the lab’s overall capability and focus. A scope with 200+ entries across multiple test categories and matrices suggests a large, diversified laboratory. A scope with 15–20 entries in a specific area suggests a specialized laboratory. Neither is inherently better — the question is whether the scope matches your needs.
Look at the methods referenced. Are they current versions of recognized standards (USP, AOAC, ASTM, EPA)? Or are they older versions, or in-house methods? In-house methods aren’t inherently problematic — some specialized tests don’t have published standard methods — but they require more scrutiny. Ask the lab for their method validation data for any in-house method you’re relying on.
Look at the matrices. A laboratory with a scope that covers a wide range of matrices in your product category — different supplement forms, different food matrices, different cosmetic types — has likely encountered the specific challenges of testing in those matrices. A lab whose scope covers only one or two matrices may not have the experience to handle unusual samples or complex matrices.
When you qualify a testing laboratory as a supplier, the scope document should be a formal part of the qualification record. Document the date you downloaded the scope, the version or revision date of the scope, and which specific tests you verified are within the accredited scope.
Build an annual review into your supplier qualification SOP. Download the current scope once a year, compare it to the previous version, and confirm that all tests you rely on are still within the accredited scope. Scope changes — tests added, tests removed, matrices changed — happen, and labs don’t always proactively notify clients when their scope changes.
If a test you rely on is removed from a lab’s accredited scope, you need to know immediately — not when you’re reviewing a batch record during an FDA inspection. Annual scope review is a 20-minute task that prevents that kind of surprise.
At Aurora TIC, scope verification is a standard step in every lab qualification engagement we conduct. The scope document is the foundation of any defensible lab qualification — everything else builds on it.