# ISO 17025 Accreditation and Your Packaging Test Data > How ISO/IEC 17025:2017 accreditation differs from compliance, why PJLA-accredited packaging reports hold up in FDA submissions, and how to vet a contract lab. Source: https://lso-inc.com/news/what-iso-17025-accreditation-means-for-your-data-bb1b27dc/ --- spokeSeptember 24, 2026 # What ISO 17025 Accreditation Means for Your Data ME Matt Emrick A test report is only as good as the lab standing behind it. When you drop a contract lab's seal strength data into a 510(k), you are betting that an FDA reviewer will accept it without asking you to run it again. That bet is a lot safer when the lab is accredited to ISO/IEC 17025:2017 for the exact method that produced the number. Here is the distinction most people blur. A lab can be _compliant_ with a standard, meaning it says it follows the requirements. A company can be _certified_ to a management-system standard like ISO 13485, meaning a registrar audited its quality system. Neither of those is what happens to a testing lab. [A lab is **accredited**, which is a third-party attestation of technical competence for a defined list of methods](https://www.iso.org/standard/66912.html) (ISO/IEC 17025:2017, [https://www.iso.org/standard/66912.html](https://www.iso.org/standard/66912.html)). The accreditation body doesn't just look at your procedures. It watches your analysts run the test, checks your equipment calibration and traceability, reviews your method validation, and then grants competence for a specific scope. Get the terminology right when you evaluate a vendor: [labs are accredited, never "ISO 17025 certified."](https://www.iso.org/standard/66912.html) ## Why Accreditation Buys You Something in a Submission The practical payoff is mutual acceptance. [ISO/IEC 17025 exists so that accredited test reports can be accepted across borders and organizations without further testing](https://www.iso.org/standard/66912.html) (ISO/IEC 17025:2017, [https://www.iso.org/standard/66912.html](https://www.iso.org/standard/66912.html)). The accreditation body assessed the lab's competence so that you, the FDA reviewer, and a European notified body don't each have to re-verify it independently. That only works if the accreditation body itself is credible. LSO's packaging test lab is accredited by Perry Johnson Laboratory Accreditation, Inc. (PJLA), certificate L26-623, accreditation number 120500. [PJLA is a signatory to the ILAC Mutual Recognition Arrangement, which is the mechanism that makes accredited data portable internationally.](https://ilac.org/latest_ilac_news/signatory-status-pjla/) When a report carries that accreditation and the method is on the documented scope, the reviewer has an external, independent assessment of the lab's competence to lean on. That is the difference between data a reviewer trusts on sight and data that invites a re-test request. One clarification, because it comes up. [FDA runs a voluntary program called the Accreditation Scheme for Conformity Assessment (ASCA), under which labs accredited to ISO/IEC 17025 plus applicable ASCA specifications by an FDA-recognized accreditation body can be formally recognized](https://www.fda.gov/medical-devices/division-standards-and-conformity-assessment/testing-laboratories-how-participate-asca) (FDA, [https://www.fda.gov/medical-devices/division-standards-and-conformity-assessment/testing-laboratories-how-participate-asca](https://www.fda.gov/medical-devices/division-standards-and-conformity-assessment/testing-laboratories-how-participate-asca)). [ASCA covers a defined list of eligible standards, mostly biocompatibility and EMC, and not every ASTM packaging method sits inside an ASCA scope.](https://www.fda.gov/medical-devices/division-standards-and-conformity-assessment/testing-laboratories-how-participate-asca) Accreditation to ISO/IEC 17025 supports the credibility of your packaging data independently of whether the lab is enrolled in ASCA. Don't let anyone tell you packaging data needs ASCA to be defensible. It doesn't. It needs to come from a competent, accredited lab, and the method needs to be in scope. ## The Scope Is the Document That Actually Matters Accreditation is not a blanket. It is a fixed list of methods. A lab can be genuinely accredited and still run a test that falls outside its scope, in which case that particular result carries no accreditation weight at all. So the single most useful thing you can do when reviewing a contract lab is pull the scope of accreditation and read it against the tests you actually need. LSO's accredited scope covers the Brea, California packaging test lab (830 Challenger Street). It is a fixed method list, and it maps cleanly onto [a full ISO 11607-1:2019 sterile barrier program](https://www.iso.org/standard/70799.html) (ISO 11607-1:2019, [https://www.iso.org/standard/70799.html](https://www.iso.org/standard/70799.html)). The in-scope methods include: - [**Seal strength** by ASTM F88, measuring the force required to separate a seal](https://www.astm.org/standards/f88) (ASTM F88/F88M-21, [https://store.astm.org/f88\_f88m-21.html](https://store.astm.org/f88_f88m-21.html)) - **Leak and integrity** by [ASTM F2096](https://www.astm.org/standards/f2096), ASTM F1929 dye penetration, and [ASTM F3039](https://www.astm.org/standards/f3039). [F1929 detects channel defects in porous packaging by visually observing dye leakage through seals](https://www.astm.org/standards/f1929), the kind of channel a contaminant could travel through (ASTM F1929-23, [https://store.astm.org/f1929-23.html](https://store.astm.org/f1929-23.html)) - [**Visual inspection** by ASTM F1886](https://www.astm.org/standards/f1886) - [**Distribution simulation** by ASTM D4169, which defines distribution cycles for handling, vibration, and compression to challenge a package against its expected shipping environment](https://www.astm.org/standards/d4169) (ASTM D4169-22, [https://store.astm.org/d4169-22.html](https://store.astm.org/d4169-22.html)), along with the supporting ASTM D-series methods and ISTA procedures 1A, 2A, 3A, and 1G - [**Conditioning** by ASTM D4332](https://www.astm.org/standards/d4332) - [**Accelerated aging** by ASTM F1980, the guide used to support a claimed shelf life through elevated-temperature exposure](https://www.astm.org/standards/f1980) (ASTM F1980-21, [https://store.astm.org/f1980-21.html](https://store.astm.org/f1980-21.html)) - [**Biological indicator incubation** per the ANSI/AAMI/ISO 11138 series, which governs the biological indicators used to demonstrate sterilization effectiveness](https://www.iso.org/standard/66442.html) (ISO 11138-1:2017, [https://www.iso.org/standard/66442.html](https://www.iso.org/standard/66442.html)) Notice what a single accredited scope does for your program. Seal strength (F88), integrity (F1929, F2096, F3039), aging (F1980), and distribution (D4169, ISTA) are the load-bearing pieces of an ISO 11607 validation, and here they sit under one accreditation. You are not stitching together reports from a strength lab, an aging lab, and a transit lab and hoping the sample chain-of-custody holds up under audit. [ISO 11607-1 sets the framework and leaves method selection to the manufacturer; these ASTM methods are how you satisfy it](https://www.iso.org/standard/70799.html) (ISO 11607-1:2019, [https://www.iso.org/standard/70799.html](https://www.iso.org/standard/70799.html)). Two boundaries worth stating plainly, because they are the kind of thing a sharp auditor checks. The accredited scope covers the Brea packaging lab only. It does not extend to LSO's other sites. And the accreditation covers _testing_, which is a separate thing from the ISO 13485 quality system that governs manufacturing. Don't let a vendor blur those two into one badge. ## How to Vet Any Accredited Packaging Lab Use the same checklist whether you are qualifying LSO or anyone else. Start with the scope document, not the logo. Confirm the specific method and, ideally, the current revision of the standard appear on the accredited scope. A lab accredited for F88 seal strength is not automatically accredited for F1929 dye penetration. If the test you need isn't listed, the resulting report is a competent lab's data, but it is not accredited data, and you should know which one you're getting. Check the accreditation body. It should be a signatory to the ILAC-MRA, which is what makes the accreditation recognized beyond the body's own paperwork. Verify the certificate number and status directly rather than trusting a PDF a salesperson emailed you. For LSO that is PJLA, certificate L26-623, and you can confirm it with the accreditation body. Confirm the physical location on the scope matches where your samples will actually be tested. Accreditation is site-specific. A lab with three facilities may hold accreditation at one. Ask which site runs your work. Then look at the things accreditation is supposed to guarantee but that you should still see evidence of: equipment calibration with documented measurement traceability, method validation records, and analyst competency records. A mature accredited lab produces these without flinching. If a request for a calibration certificate or a method validation summary generates a long pause, that tells you something. The reason all of this matters lands in one place: audit and submission scrutiny. [Under the QMSR, FDA expectations now flow through ISO 13485:2016](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr), and supplier oversight and objective evidence are central to how your quality system is judged. When your [packaging validation](https://lso-inc.com/solutions/packaging-validation/) rests on data from an independently assessed, accredited lab, you have handed the reviewer a shorter path to confidence. The report says what it measured, the method is on a documented scope, the lab's competence was verified by a recognized body, and nobody has to re-run the test to believe the number. That is the entire point of accreditation, and it is worth insisting on before your samples ever ship. For how these methods fit together across a full validation, see our companion pieces on accelerated aging versus real-time aging and the packaging validation mistakes that delay FDA clearance. If you're consolidating packaging validation under fewer partners, our team can walk your quality group through the Brea lab's accredited scope, certificate L26-623, and how the data maps to your ISO 11607 program in a 30-minute technical review. [Request a Quote](https://lso-inc.com/contact/) ## Ship faster with fewer vendors LSO consolidates assembly, packaging, validation, and sterilization under one roof — FDA-registered, ISO 13485-certified, across three facilities. Tell us about your device and we'll map the fastest path to production. Or call us directly: [(714) 672-1090](tel:7146721090)