Quality Assured Test House Capabilities
Reviewers judge laboratory evidence on two questions: was the study designed to a recognised standard, and can the laboratory demonstrate its competence?
Accreditations and standards
Standards reviewers expect to see
Our protocols reference the CLSI, ICH and ISO documents that notified bodies, such as the MHRA and the FDA, expect to see and our quality management system provides the traceability behind every result. The tables below show which standards we apply to our clinical and analytical performance evaluation services, and where.
Accreditation
ISO/IEC 17025
Abingdon Analytical is accredited to ISO/IEC 17025, the international standard for testing and calibration laboratory competence. View our certificate.
Read more: Why ISO/IEC 17025 Accreditation Matters to Your Regulatory Submission
Standards and guidelines
CLSI and ICH guidelines
CLSI guidelines
Many Clinical and Laboratory Standards Institute (CLSI) guidelines are FDA-recognised consensus standards and are widely referenced in IVDR technical documentation. We use these principles to set sample sizes, replicate structures and acceptance criteria, so your data satisfy a regulatory notified body or reviewer's statistical questions before they are asked.
ICH guidelines
International Council for Harmonisation (ICH) Q2(R2) and Q14 guidance sets out how analytical performance evaluation procedures should be developed and validated. We will apply their principles to method development and validation, particularly for critical reagents, calibrators and materials where pharmaceutical-grade expectations apply.
Evidence reports
Standards we apply
Our clinical and analytical verification and validation (V&V) evidence reports are structured to drop into your technical documentation, whichever market you are entering first.
| Standard | What it covers | Where we apply it |
|---|---|---|
| CLSI EP05, EP15 | Precision and user verification | Repeatability and reproducibility studies |
| CLSI EP06 | Linearity | Measuring range studies |
| CLSI EP07, EP37 | Interference testing | Analytical specificity |
| CLSI EP12 | Qualitative test performance | Lateral flow and other qualitative assays |
| CLSI EP17 | LoB, LoD and LoQ | Analytical sensitivity |
| CLSI EP25 | Reagent stability | Shelf-life and in-use claims |
| CLSI EP35 | Specimen type equivalence | Matrix equivalence |
| ICH Q2(R2), Q14 | Analytical procedure validation and development | Method development and validation |
| ISO 20916 | Clinical performance studies for IVDs | Clinical study design and conduct |
| ISO 23640 | Stability of IVD reagents | Stability protocols |
| ISO 14971 | Risk management | Study scoping and flex testing |
| IEC 62366-1 | Usability engineering | Usability studies |
| ISO 10993 series, ISO 11737-1 | Biological evaluation and bioburden | Planned medical device services |
Regulatory pathways
Regulatory pathways our study designs reference
| Market | Framework | Typical evidence our studies feed |
|---|---|---|
| EU | IVDR (EU) 2017/746; MDR (EU) 2017/745 | Performance evaluation report, PMPF |
| UK | UKCA marking, MHRA registration | Performance evaluation, technical documentation |
| US | FDA 510(k), De Novo, CLIA waiver | Analytical and clinical performance data, validation and verification evidence, flex studies |
Independence
Impartiality
Our independence as a test house is enforced through four core management controls:
Commercial Separation
Technical and testing personnel operate independently of commercial, sales, or revenue targets to eliminate conflicts of interest.
Governance & Oversight
Routine impartiality risk assessments and independent management reviews evaluate potential threats to objectivity. Transparent reporting lines guarantee results remain unbiased.
Financial Insulation
Remuneration for testing personnel is entirely detached from the outcome of tests or the volume of testing completed.
Contractual Commitments
All staff and contractors sign binding impartiality and confidentiality agreements upon joining.
From the Knowledge Centre
Read more on Accreditations and standards
Practical guidance from the specialists who deliver this work every day.
Article
Why ISO/IEC 17025 Accreditation Matters to Your Regulatory Submission
Learn how ISO/IEC 17025 accreditation supports reliable testing, method validation and regulatory confidence for medical devices and diagnostics.
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Frequently asked questions
Accreditations and standards FAQs
ISO 13485 is the internationally recognised quality management system standard for medical device manufacturers. It helps organisations establish controlled processes that support product quality, regulatory compliance and market access.
ISO/IEC 17025 is the international standard for testing and calibration laboratories. Accreditation demonstrates technical competence, validated methods and robust quality processes for laboratory testing activities.
ISO 13485 focuses on quality management systems for medical device manufacturers, while ISO/IEC 17025 applies to the competence of testing laboratories. Together, these standards support product development, testing and regulatory compliance.
International standards provide recognised frameworks for quality management, risk management, testing and validation. Implementing appropriate standards can help manufacturers meet the expectations of FDA, MDR and IVDR regulatory pathways.
Accredited laboratories and established quality systems help ensure that testing data is reliable, traceable and generated through controlled processes. This evidence can strengthen technical documentation and regulatory submissions for medical devices and IVDs.
Start the conversation
Discuss your Performance Evaluation study
Tell us about your device, its intended purpose and the markets you are targeting, and we will map the studies your submission needs.
- ISO/IEC 17025 accredited (UKAS 32723)
- CLSI, ICH and ISO referenced protocols
- Evidence for IVDR, UKCA and FDA