A regulatory submission is only as strong as the evidence behind it. Dr Baranse Ozturk, Site Lead at Abingdon Analytical, explains how ISO 17025 accreditation helps testing laboratories demonstrate technical competence and generate evidence that regulators can trust.
Even a well-designed performance evaluation study may face additional scrutiny from regulatory bodies if the testing laboratory cannot demonstrate the technical competence, traceability and controls behind its results. For developers of medical devices and diagnostics navigating multiple regulatory pathways, that scrutiny can translate into delays, additional queries from reviewers, or repeat testing all of which carry a real cost in time and resources. ISO/IEC 17025 provides an internationally recognised framework for demonstrating that competence.
Our dedicated validation and verification laboratory in Doncaster, UK, was awarded ISO/IEC 17025 accreditation in September 2026, so this is a timely opportunity to explore what accreditation means in practice, both for how we operate and for the organisations that rely on our data.
What ISO/IEC 17025 Accreditation Demonstrates
ISO/IEC 17025 is the international standard for testing and calibration laboratories. It focuses on a laboratory’s ability to produce valid, reliable and defensible results, rather than assessing general business processes alone. The standard covers both management and technical requirements:
- Management requirements include document control, contract review, complaints, corrective action, internal audits and management review.
- Technical requirements address the factors that directly influence the reliability of results, including personnel competence, environmental conditions, method validation, equipment calibration, measurement traceability, sampling and reporting.
For diagnostics developers and medical device manufacturers, that distinction matters, ensuring that a laboratory has the systems and technical expertise needed to perform the activities listed within its accredited scope.
In the UK, ISO/IEC 17025 accreditation is granted and maintained by the United Kingdom Accreditation Service (UKAS), the sole national accreditation body recognised by government for this purpose. Accreditation is not a single event; UKAS carries out regular surveillance visits, and the scope of accreditation specifies precisely which tests, methods and matrices a laboratory is approved to report against, rather than covering the laboratory’s activities in general.
What Accreditation Means in Practice
For organisations using our performance evaluation testing services, studies performed within the accredited scope offer several practical benefits.
A stronger evidence trail. Accredited activities are supported by controlled methods and documented traceability. This helps create a clear, auditable link between a reported result, the method used, the equipment involved, and the personnel who performed the work.
Validated and verified methods. Method validation and verification is central to reliable laboratory testing. Non-standard or laboratory-developed methods, and standard methods used outside their intended scope, require appropriate validation. Standard methods also need to be verified so the laboratory can demonstrate that the test and studies perform as intended in its own environment.
Internationally recognised assurance. ISO 17025 is recognised across major regulatory markets. Accreditation gives clients and regulators confidence in the laboratory’s expertise and methods, although the acceptance of evidence remains subject to the requirements of the relevant regulator, notified body and submission pathway.
Quality is not a one-time achievement. It requires continual demonstration and continuous improvement. Accreditation is maintained through an ongoing commitment to quality and compliance. Regular surveillance, internal audits, method verification and review, management oversight, and the effective implementation of corrective actions are essential to demonstrate continued conformity with ISO/IEC 17025 requirements and maintain accredited status.
Clear handling of the unexpected. No laboratory eliminates every anomaly, but how they handle deviations, non-conforming results and how complaints are investigated, recorded and closed out matter most. A documented corrective action process, reviewed as part of routine management review, is one of the clearest indicators of how seriously a laboratory treats its accredited status.
Accreditation Is a Foundation, not a Guarantee
It is important to be clear about what accreditation does and does not mean. ISO/IEC 17025 provides an internationally recognised framework for competence, impartiality and consistent laboratory operation. It does not replace robust study design, sound scientific judgement or a strong quality culture.
The value comes from how the framework is applied in practice:
- How methods are developed, validated and controlled
- How data and performance trends are monitored and reviewed
- How non-conformities are investigated to identify root causes
- How corrective and preventive actions are implemented to drive continual improvement
Accreditation should be viewed as a robust foundation for confidence in laboratory data, rather than a guarantee of a specific regulatory outcome.
We experienced this first-hand during our own accreditation journey. Achieving accreditation required more than meeting the requirements of an assessment; it required embedding a disciplined approach to method control, data review, trend monitoring, investigation and corrective action throughout day-to-day laboratory operations. It is this culture of continual improvement and evidence-based decision-making, rather than the certificate itself, that ultimately delivers confidence in data quality and laboratory performance.
Why Accreditation Changes the Conversation
The most valuable benefit of accreditation is often realised before a study even begins.
Without an accredited scope to reference, early discussions with a testing partner frequently focus on reassurance: Can the laboratory demonstrate traceability? Has the method been appropriately validated? Will the resulting data withstand scientific and regulatory scrutiny? These are entirely reasonable questions but answering them can consume valuable time when submission timelines are already underway.
Accreditation moves those questions upstream. Because UKAS has already assessed, and continues to assess, a laboratory’s competence against its declared scope, stakeholders can start from a recognised and independently verified baseline rather than having to establish one from first principles. This does not remove the need for due diligence; rather, it allows discussions to focus more quickly on whether a specific study, matrix, methodology or regulatory pathway is appropriately aligned with the laboratory’s accredited capabilities.
The same principle applies from a regulatory perspective. Regulatory reviewers must still be satisfied that the underlying data is reliable and scientifically sound. Where that data has been generated within an accredited scope, reviewers have an independent point of reference for assessing laboratory competence, rather than relying solely on information presented within the submission. This can reduce the number of foundational questions raised during review and allow greater focus on study design, scientific interpretation and the relevance of the evidence to the intended use; areas where scientific judgement provides the greatest value.
Accreditation does not make a study’s conclusions correct, and it does not replace good science. No certificate can substitute for robust study design, appropriate controls, sound methodology or expert interpretation. What accreditation does provide is a recognised framework of confidence, allowing the science to be evaluated on its own merits rather than requiring trust in the laboratory to be established from the beginning every time. For organisations managing multiple studies, submissions or testing partners, that benefit compounds significantly, creating a foundation of confidence that improves efficiency, consistency and credibility across the entire development programme.
Why This Matters for Diagnostics and Medical Devices
For diagnostics developers navigating UKCA, CE marking under the IVDR or FDA submission pathways, and for medical device manufacturers preparing technical documentation under the EU MDR, laboratory data forms an important part of the evidence package.
Selecting the right testing partner is, therefore, more than an operational decision. The laboratory must be able to demonstrate that its methods, equipment, personnel, traceability and reporting are appropriate for the work being performed. Where testing falls within an accredited scope, ISO/IEC 17025 provides an independently assessed basis for that confidence.
Questions Worth Asking Any Testing Partner
Accreditation status alone does not answer every question a study sponsor should ask. The following points are worth confirming with any prospective laboratory, accredited or not.
- Is this specific test within the accredited scope? Accreditation is granted against a defined scope of tests, methods and matrices, not to a laboratory. A laboratory may be accredited for some activities and not others, so it is worth confirming that the exact test required is included.
- How are methods validated or verified? Ask what evidence exists that a method performs as expected in that laboratory’s own hands, particularly for non-standard, laboratory-developed or modified methods.
- What happens when something does not conform? A laboratory’s corrective action process, and its willingness to discuss past non-conformities and how they were resolved, is often a more useful indicator of quality culture than the certificate itself.
Building Confidence into Your Evidence Package
Strong evidence is not created by the final report alone. It is built through appropriate study design, controlled methods, competent personnel and traceable execution from the outset.
ISO/IEC 17025 accreditation provides a structured framework within which laboratory competence is independently assessed. For organisations preparing regulatory submissions, working with an accredited laboratory can help strengthen the traceability and defensibility of the supporting data, while reducing avoidable uncertainty in the evidence-generation process.
Abingdon Analytical supports diagnostics and medical device developers with structured testing and evidence generation aligned to recognised standards including ISO/IEC 17025. Speak to our team to discuss your study requirements and the activities covered by our accredited scope.
