2026 surveillance audit at AbroadLink: renewal of our ISO 9001, ISO 13485 and ISO 17100 certifications
At AbroadLink Translations, we are delighted to announce the renewal of our ISO 9001, ISO 17100 and ISO 13485 certifications for 2026. This milestone highlights our ongoing commitment to quality standards, accuracy and compliance in multilingual projects, particularly in life sciences and medical devices.
This renewal comes after an external surveillance audit carried out by Bureau Veritas, providing independent confirmation that the system is consistently applied, that controls remain effective, and that continuous improvement is demonstrated through real actions.
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What each ISO certification renewal means (and why it is relevant for our clients’ documentation)
ISO 9001 is the leading standard for quality management systems. It helps us work with defined and measurable processes to provide a consistent, client-oriented service.
ISO 17100 is the specific standard for translation services. It sets out requirements for resources, processes and delivery, reinforcing language quality assurance and traceability in each project.
ISO 13485 is focused on quality management in the medical device sector and regulatory requirements. Its emphasis on control, evidence and traceability is particularly important when documentation impacts compliance and safety.
What is a surveillance audit?
A surveillance audit checks that the system “truly works”: it is applied in day-to-day operations, indicators are monitored, incidents are managed and improvements are validated. For clients, this makes quality demonstrable through clear, consistent and repeatable practices.
Why is it key in life sciences and regulated sectors?
In regulatory and technical documentation, risk is not limited to language errors: consistency between versions, change control and terminological consistency also matter. In the EU, frameworks such as Regulation (EU) 2017/745 (MDR) on EUR-Lex and Regulation (EU) 2017/746 (IVDR) on EUR-Lex increase documentation demands.
Furthermore, when notified bodies are involved in conformity assessment, maintaining consistent documentation is essential, as illustrated by notified bodies for medical devices (European Commission).
Benefits for you as a client
Renewing these certifications for 2026 has certain practical advantages:
- Consistency across projects, languages and teams.
- Traceability (who did what, when, and under which criteria).
- Fewer incidents thanks to defined processes and controls.
- Better change control for projects with multiple versions.
- Quality assurance supported by external review.
If your documentation is linked to regulated environments, you may be interested in specialised services such as medical device translation and pharmaceutical translation.
Conclusion
Once again, by renewing our ISO 9001, ISO 17100 and ISO 13485 certifications at AbroadLink following a surveillance audit, we show our clients that our quality management remains reliable with stable processes, consistent controls and a verifiable quality culture.
If you are looking for a translation agency with a focus on quality and traceability, we would be happy to help.
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Josh Gambin holds a 5-year degree in Biology from the University of Valencia (Spain) and a 4-year degree in Translation and Interpreting from the University of Granada (Spain). He has worked as a freelance translator, in-house translator, desktop publisher and project manager. From 2002, he is a founding member of AbroadLink and is the Head of Sales and Strategy of the company.
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