How to Evaluate ISO/IEC 17025 Accreditation Scope for Medical Device Testing

A lab can hold ISO/IEC 17025 accreditation and still not be accredited for the specific tests your device requires. Jason Langhorn, with hands-on experience across medical device testing programs, explains how to read accreditation scope correctly, what the consequences are when there’s a mismatch, and the questions to ask before you commit to a testing partner.

 

Why Accreditation Scope Is the Detail Most Manufacturers Miss

A lab can be ISO/IEC 17025 accredited and still not be accredited for the specific tests your medical device requires. This is the detail that trips up even experienced procurement and quality teams, and it’s one of the most common reasons test data gets challenged during regulatory review.

ISO/IEC 17025 accreditation is scope-specific. The certificate tells you the lab meets the standard’s requirements, but only for the methods and parameters listed in its annexe. A lab accredited for tensile strength testing is not automatically accredited for fatigue testing. A lab accredited for electrical safety to one edition of IEC 60601 may not hold accreditation for a revised version. The certificate is a starting point, not a guarantee of coverage.

To verify scope before committing to a lab, manufacturers should ask for the Schedule of Accreditation (sometimes called the Scope Document) directly from the accreditation body, not just from the lab. In the US, A2LA and NVLAP publish these schedules publicly. In Europe, look for the lab’s entry in the ILAC-registered national accreditation body database. Check that your specific test standard, edition, and parameter range are listed.

Three things to confirm when reviewing a lab’s Schedule of Accreditation:

• The test standard and edition match what your device program requires (e.g., ISO 10993-5:2009 not just “ISO 10993 series”)
• The specific parameter or analyte is listed (e.g., particular extractables techniques like ICP-MS or GC-MS are named, not implied)
• The accreditation is current and held at the specific facility location where your testing will be performed (not a sister site)

If a lab cannot clearly confirm all three of these points, that is a signal to probe further before committing.

 

What This Looks Like in Practice

A manufacturer developing a polymer-based implantable device selected a laboratory holding ISO/IEC 17025 accreditation and proceeded with chemical characterization testing to support a biocompatibility evaluation under ISO 10993. The scope check had not been carried out at method level.

During regulatory review of the 510(k) submission, a reviewer flagged that the specific extractables analysis technique used was not listed in the laboratory’s Schedule of Accreditation. The testing itself had been competently performed, but the absence of accreditation coverage for that analytical method introduced questions about method validation and measurement traceability. The manufacturer was asked to provide supplementary documentation.

In this case, the documentation was accepted. In others, manufacturers elect to repeat testing at a lab whose scope explicitly covers the method, to avoid extended regulatory dialogue. Either way, the delay and the additional cost were preventable with a scope check before the program started.

 

What Regulators Actually Look For, and Where Scope Gaps Create Risk

The FDA does not explicitly mandate ISO/IEC 17025 accreditation for 510(k), De Novo, or PMA submissions. But the agency consistently expects test data to be scientifically valid, reproducible, and defensible. When a reviewer questions the competence of the lab that generated the data, that becomes your problem, not the lab’s.

In Europe, MDR (EU 2017/745) and IVDR (EU 2017/746) have significantly raised the bar on technical documentation quality. Notified Bodies are now asking harder questions about test method validity and the competence of labs that generated the data. Using a lab without scope-matching accreditation can lead to requests for additional evidence or re-testing, at a point in the process when delays are most costly.

For manufacturers targeting multiple markets, using labs participating in the ILAC Mutual Recognition Arrangement (MRA) means accredited results may be accepted across regions, reducing the need to repeat testing. But that benefit only applies when the accreditation scope matches the tests in question. Scope gaps don’t disappear across borders.

The practical risk: a manufacturer proceeds with testing, receives a report, submits to a regulatory body, and only at review stage discovers the lab was not accredited for that specific method or version of the standard. The cost is not just the testing budget. It is the timeline.

 

What Accreditation Scope Does (and Doesn’t) Tell You About a Lab

Scope confirmation tells you a lab is authorized to run a specific test. It does not tell you how experienced the team is, how well the lab communicates, or whether the reporting will meet the depth regulators expect. Manufacturers need both.

What accreditation scope confirms:

Measurement traceability
Results are linked to recognized national or international standards through documented calibration chains.

Method validation
The specific method listed in the schedule has been validated and is fit for purpose under the lab’s conditions.

Ongoing performance monitoring
Participation in proficiency testing and inter-laboratory comparisons provides independent verification that results remain consistent over time.

What accreditation scope does not confirm: whether the team running the test has done it on devices like yours before, whether the lab understands the regulatory context for your submission, or whether reporting will be detailed enough to withstand review. That is where technical conversations with the lab matter, before you place an order.

 

Questions to Ask a Lab Before You Commit

Before committing to a testing program, these are the questions worth asking directly. A confident, specific answer to each is a positive signal. Vague or hedged answers warrant follow-up.

Scope and coverage:

• Can you provide the Schedule of Accreditation from your accreditation body, and confirm the specific test standard, edition, and parameters that are in scope?
• Is the testing I need accredited at this specific facility, or at a different location within your network?
• If any of my required tests fall outside your accreditation scope, what is the process for conducting and documenting those tests, and how will that be reflected in the report?

Regulatory and reporting depth:

• Can you share a sample report for this type of testing, so I can assess whether the reporting format and level of detail will meet regulatory expectations?
• Have you worked with similar device types before, and are you familiar with the specific regulatory pathway (FDA 510(k), MDR, etc.) this data will be used to support?

Engaging the lab early in the development process, before testing starts, gives you time to address scope gaps, clarify reporting requirements, and build a test plan that holds up at submission.

 

Where Scope Gaps Carry the Highest Risk

Scope gaps cause more problems in some testing areas than others. The highest-risk areas are those where results directly influence safety determinations or where the analytical technique is highly sensitive to calibration and method execution.
Biocompatibility and chemical characterization are where scope gaps most frequently surface during regulatory review. Evaluations under ISO 10993 increasingly depend on advanced analytical techniques, including GC-MS, LC/HR-MS, and ICP-MS, each of which must be explicitly listed in the Schedule of Accreditation to provide full coverage. Because chemical characterization results directly underpin safety conclusions, regulators examine the traceability and validation of these methods closely. A lab accredited for “ISO 10993 biocompatibility testing” is not necessarily accredited for the specific extraction and analytical techniques your program requires.
Sterility and microbiological testing carries similar risk. Quantitative measurement precision is central to sterility assurance level claims under ISO 11135, ISO 11137, and ISO 11737. Variability in method traceability can influence the validity of those claims, making scope alignment particularly important at the method level, not just the standard level.
Electrical safety and EMC testing under IEC 60601 depends on precise electrical measurement and calibration traceability. This is also an area where standard editions matter: accreditation for one version of a test standard does not automatically apply to a revised edition. Confirm the exact edition your submission requires.

When No Lab Holds Full Accreditation for a Required Method

For testing involving emerging materials, advanced analytical techniques, or research-stage methodologies, manufacturers sometimes find that no lab holds ISO/IEC 17025 accreditation for the specific method required. This is more common than many teams expect, particularly in chemical characterization for novel polymers or in biological evaluations for combination products. There are three accepted approaches when this happens.

1. Documented technical justification

The manufacturer works with the lab to produce documentation showing that the analytical technique is scientifically appropriate and aligned with established methodologies. This typically includes method validation data, measurement uncertainty estimates, and relevant technical literature. Regulatory reviewers are less focused on whether a technique appears in a scope schedule than on whether its scientific validity and traceability are clearly demonstrated.

2. Subcontracting to a specialist lab

The primary lab manages the overall testing program and quality framework, while specific analytical techniques are subcontracted to a lab that holds accreditation for those methods. ISO/IEC 17025 includes provisions for managing subcontracted work, so the arrangement can be structured transparently and documented in the final report.

3. Method validation within an accredited quality system

Even when a specific method falls outside formal accreditation scope, testing conducted within an ISO/IEC 17025-accredited lab still benefits from the broader quality controls: calibrated equipment, qualified personnel, and documented data integrity. When a method is properly validated and these controls are documented, results can still be scientifically robust and suitable for regulatory evaluation.

In all three cases, transparency is the most important factor. Knowing which option applies to your program and having that documented upfront puts you in a much stronger position if a reviewer asks questions.

ISO/IEC 17025 accreditation matters, but the certificate alone is not enough. The question worth asking is not whether a lab is accredited, but whether its accreditation scope covers the specific tests your device program requires. Checking the Schedule of Accreditation before you start, asking direct questions about scope and reporting, and involving your testing partner early in the development process are the steps that reduce the risk of data challenges at the worst possible time. To learn more about how Element’s accreditations align to medical device testing programs, visit our accreditations and approvals page or speak with one of our technical experts.