Here is a problem I watch teams walk into more often than they should: the packaging validation is done, the data looks clean, and then a supplier auditor or an FDA reviewer asks the one question the program can't answer cleanly. Where did this data come from, and how do you know the lab that generated it was competent to run the method?
If the answer is "an unaccredited lab ran it," you've just opened a door. Sometimes that door leads to a clarifying question. Sometimes it leads to re-testing, an Additional Information request, and weeks or months added to a timeline that was supposed to be closing out.
That risk is real and it is getting more attention, not less. FDA has publicly reminded device firms about a rise in fabricated, duplicated, and otherwise unreliable third-party laboratory testing data in premarket submissions, and told firms to vet their labs and independently verify results (FDA, Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions). When the agency is actively skeptical of test-data provenance, "trust us, the numbers are good" is not a strategy.
So the news first, then why it matters: LSO's in-house packaging test lab is now accredited to ISO/IEC 17025:2017. The accreditation covers the packaging test lab and its accredited methods, not the company as a whole.
Why Data Provenance Became a Problem
Most people assume the fight in a packaging validation is over the numbers themselves. Does the seal hold at 1.8 lbf/in? Did the package survive distribution and aging? Those matter, but they are not usually where submissions and audits get stuck.
Where they get stuck is the credibility of the data. That data lives in your files and comes out during audits, inspections, and any time a reviewer digs in. When it comes out, the reviewer is not just reading results. They are asking whether the lab that produced those results was competent, whether the methods were controlled, and whether the numbers can be trusted without re-doing the work.
For an OEM consolidating vendors, this is a supplier-qualification issue as much as a regulatory one. A quality auditor evaluating your contract manufacturer will look at where the packaging data originates. Data from an independently assessed lab holds up. Data from a lab nobody has assessed invites the follow-up questions that eat schedule.
What ISO/IEC 17025 Accreditation Actually Is
This is where language gets sloppy, so I'll be precise.
Under ISO/IEC 17025, laboratories are accredited, not certified. Accreditation is a third-party accreditation body's independent attestation of a lab's technical competence, tied to a specifically defined scope of methods (ISO/IEC 17025:2017). It is not a self-declaration and it is not a one-time audit. An accreditation body assesses the lab against the standard, confirms the lab can competently perform the specific test methods in its scope, and then keeps checking through ongoing surveillance.
Three things are worth pulling out of that.
First, it is independent. A qualified outside body did the assessment, not us and not a customer.
Second, it is method-level. Accreditation attaches to defined test methods within a defined scope, not to a building or a brand. This is the single most misunderstood point, and it is why the phrasing discipline matters: the lab is accredited for the methods in its scope.
Third, it is ongoing. Surveillance means the competence is monitored over time, not attested once and forgotten.
Accreditation Is Not Certification, and Auditors Know the Difference
Certification and accreditation are different activities that answer different questions, and conflating them is a tell that a supplier doesn't understand its own quality claims.
ISO/IEC 17025 accreditation is a lab-level attestation of technical competence for specific test methods. It answers a narrower and, for test data, more pointed question: is this lab technically competent to run this method and produce trustworthy results?
LSO now holds both: an ISO 13485:2016 manufacturing QMS and an ISO/IEC 17025:2017 accredited packaging test lab.
What Accreditation Does Not Do
I want to be straight about the limits, because overselling this would be its own credibility problem.
Accreditation does not make your data unchallengeable, and it does not remove your obligation to verify results. FDA has been explicit that using an accredited lab does not replace the firm's own verification of the data it relies on (FDA, Fraudulent and Unreliable Laboratory Testing Data in Premarket Submissions). You still own your submission. You still review the reports. You still need protocols with justified parameters, defined worst-case conditions, and traceability back to your design history file. Accreditation strengthens the provenance of the data. It does not do your regulatory homework for you.
When a reviewer or auditor asks where the packaging data came from and whether the lab was competent to produce it, that question now has a clean answer.
The Bottom Line
Most packaging validation delays I see are preventable, and provenance is one of the more preventable ones. You can run the right methods, hit the right numbers, and still lose weeks because the data came from a lab nobody assessed. Getting seal strength, aging, and distribution data from an ISO/IEC 17025 accredited lab closes that gap before it opens.