ISO 17100 in Medical Translation: What It Means and Why It Matters for Your Project

Key Takeaways

• ISO 17100:2015 is the international quality standard for translation services, covering translator qualifications, the translation process, and quality control requirements.
• For medical translation, ISO 17100 is not a marketing badge — it defines the minimum process required to produce safe, reliable translations for regulated use.
• The standard mandates independent review by a second qualified translator, which is the single most important quality safeguard in medical translation.
• When commissioning medical translations for regulatory submissions, procurement teams and regulatory affairs departments should ask for ISO 17100 certification as a baseline requirement.
• Certification alone is not sufficient — ask specifically how the agency applies the standard, who reviews your translations, and what their subject-matter qualifications are.

If you have ever requested a quote from a translation agency, you have almost certainly seen “ISO 17100 certified” somewhere in their credentials. But what does it actually mean, and why does it matter specifically for medical translation?

This article explains what ISO 17100:2015 requires, how it applies to medical and pharmaceutical translation projects, and what questions to ask to distinguish agencies that genuinely apply the standard from those that treat it as a box-ticking exercise.

What Is ISO 17100:2015?

ISO 17100:2015 is the international standard published by the International Organization for Standardization (ISO) that defines quality requirements for translation services. Its full title is Translation services — Requirements for translation services.

The standard replaced the earlier European standard EN 15038 in 2015 and is now the globally recognised benchmark for professional translation quality management. It covers:

• Translator and reviser competence requirements
• The core translation process (translation, revision, proofreading, final verification)
• Project management requirements
• Customer agreements and confidentiality
• Handling of source and target files

Agencies that claim ISO 17100 certification have been audited by an accredited certification body (such as BSI, Bureau Veritas, or TÜV SÜD) and confirmed to operate processes that meet the standard’s requirements.

What Does ISO 17100 Actually Require?

Translator Competence

Under ISO 17100, translators must demonstrate competence through one of the following:

• A recognised degree in translation
• A degree in any other subject combined with two years of documented professional translation experience
• Five years of documented professional translation experience

For medical translation, this baseline is necessary but not sufficient. The standard does not specify subject-matter expertise requirements — that is a judgement call for the agency. A responsible medical translation agency will require translators to have relevant medical, pharmaceutical, or biomedical qualifications in addition to meeting the ISO 17100 competence criteria.

The Two-Step Process: Translation and Revision

The most important practical requirement of ISO 17100 is the mandatory two-step process:

Translation — the primary translator produces the target text from the source document.

Revision — a second, independent qualified translator reviews the translation against the source document, checking for accuracy, completeness, terminology consistency, and suitability for purpose.

This independent revision step is not optional under ISO 17100. It is the core quality safeguard that distinguishes a compliant translation from a single-translator output. For medical documents where a missed phrase or wrong term can have direct patient safety consequences, this step is critical.

Note: revision under ISO 17100 is specifically a bilingual review — the reviser works with both source and target documents. It is not the same as proofreading, which is monolingual.

Project Management Requirements

ISO 17100 also specifies requirements for project management, including:

• Pre-production processes: agreement on scope, terminology resources, reference materials, and delivery format
• Handling of client-supplied glossaries and translation memories
• Final verification before delivery (checking formatting, completeness, and file integrity)
• Complaint and feedback handling

These requirements matter for medical projects, where terminology consistency across product lines and multiple language pairs is a regulatory concern as much as a quality one.

Why ISO 17100 Matters Specifically for Medical Translation

Regulatory Submissions Require Documented Quality

When you submit a translation as part of a regulatory dossier — whether that is an EU MDR technical file, an EMA marketing authorisation application, or an MHRA submission — the regulatory body expects the translation to have been produced to a documented quality standard. ISO 17100 certification provides auditable evidence that the required processes were followed.

If a regulator questions a translation, or if a product recall investigation examines your documentation, being able to demonstrate ISO 17100 compliance is considerably more defensible than relying on an agency’s assurance of quality without documentary evidence.

The Revision Requirement Catches Critical Errors

In general translation, a single experienced translator often produces output that is entirely fit for purpose. For most business documents, a single-translator workflow is proportionate to the risk.

Medical documents are different. An IFU that contains a dosage error, a contraindication translated with altered meaning, or a safety warning that has been softened in the target language represents a direct patient safety risk. The mandatory independent revision under ISO 17100 exists precisely to catch errors that the primary translator — however qualified — may not detect in their own work.

Research consistently shows that independent review catches errors that self-review misses. This is true across professions, and translation is no exception.

Terminology Consistency Across Product Lines

ISO 17100’s project management requirements include provisions for terminology resources and translation memories. For medical device manufacturers with multiple products, multiple language versions, and ongoing documentation updates, this matters directly.

Consistent terminology across IFUs, labelling, technical files, and post-market surveillance documents is a regulatory expectation under EU MDR and similar frameworks. An ISO 17100-certified agency with proper project management processes is better placed to maintain that consistency over time than an agency without documented workflows.

What ISO 17100 Does Not Cover

ISO 17100 is a process standard, not a subject-matter standard. It tells you that the agency has a defined, auditable translation process — it does not guarantee that translators are qualified in your specific medical field.

This distinction matters. An agency can be fully ISO 17100 compliant and still assign a translator with general medical experience to a highly specialised cardiovascular device IFU. The standard does not prevent this.

When evaluating a medical translation agency, ISO 17100 certification is a necessary starting point, not a sufficient one. Ask specifically:

• How do you select translators for medical projects?
• What subject-matter qualifications do your medical translators hold?
• Can you demonstrate that the reviser on my project has relevant sector experience?
• How do you manage terminology consistency across an ongoing project?

An agency that is genuinely applying ISO 17100 in a meaningful way will have clear, specific answers to these questions.

ISO 17100 vs Other Translation Standards

A small number of translation agencies also hold ISO 13485 certification, which covers their role as a supplier within a medical device manufacturer’s quality management system. This is a more demanding credential than ISO 17100 alone and may be relevant for device manufacturers who need to include their translation supplier in their technical file.

How to Verify ISO 17100 Certification

ISO 17100 certification is issued by accredited third-party certification bodies. You can verify an agency’s certification by:

• Asking for their certificate, which will show the certification body, scope, and expiry date
• Checking directly with the certification body (BSI, Bureau Veritas, TÜV SÜD, and others publish lists of certified organisations)

Be cautious of agencies that describe themselves as “ISO 17100 compliant” or “working to ISO 17100 standards” without holding formal third-party certification. Self-declared compliance is not the same as certification.

Summary

ISO 17100:2015 is the foundation of professional medical translation quality. It mandates translator competence, independent bilingual revision, and documented project management processes — all of which are essential for translation work that will be used in regulatory submissions, patient-facing materials, or clinical settings.

For anyone commissioning medical translation, ISO 17100 certification from an accredited body should be a baseline requirement. The questions you ask beyond that — about subject-matter expertise, terminology management, and the specific credentials of the translators assigned to your project — are what distinguish a genuinely qualified agency from one that holds a certificate without applying its principles.

Global LTS holds ISO 17100:2015 certification and provides certified medical translation services for medical device manufacturers, pharmaceutical companies, and clinical research organisations across 32+ languages. Contact us for a free project consultation.