26 May ISO-Certified Medical Translation Services: Quality, Compliance and Patient Safety
In medical translation, quality is not optional. A single mistranslation can affect patient safety, regulatory compliance or the reliability of scientific information. That is why at Okodia we apply strict quality processes based on internationally recognised ISO standards.
Our certifications — ISO 17100, ISO 18587 and ISO 9001 — guarantee that every medical translation project follows verified procedures designed to ensure accuracy, consistency and confidentiality.
If you are looking for a reliable medical translation agency, here is how these standards work and how we apply them in our daily operations.
Why ISO standards matter in medical translation
ISO standards are international frameworks that define quality, safety and operational requirements for organisations worldwide. In the medical and healthcare sector, these standards are particularly important because they help minimise risks and ensure linguistic precision in highly sensitive documentation.
Medical translation projects often involve:
- Clinical trial documentation
- Medical reports
- Pharmaceutical leaflets
- Instructions for medical devices
- Scientific publications
- Regulatory submissions
- Patient information materials
Errors in any of these documents can have serious legal, medical or reputational consequences. ISO certification helps ensure that translation providers work according to robust and controlled procedures.
How ISO certification works
To obtain an ISO certification, companies must undergo a demanding external audit process carried out by accredited organisations such as AENOR or Bureau Veritas.
The process usually includes:
- Internal process review
- Documentation assessment
- Audit of real translation projects
- Evaluation of workflows and staff qualifications
- Ongoing follow-up audits
Certification is not permanent. Companies must continue proving compliance through regular audits and continuous improvement measures.
Okomeds’ ISO certifications for medical translation
At Okomeds, we currently hold three key certifications:
- ISO 17100:2015 – Translation services
- ISO 18587:2017 – Post-editing of machine translation
- ISO 9001:2015 – Quality management systems
These certifications support our commitment to delivering reliable medical and life sciences translations with maximum linguistic and procedural quality.
ISO 17100: Quality standards for professional medical translation
What is ISO 17100?
ISO 17100 is the international standard specifically developed for translation services. Rather than evaluating the final translated text alone, it regulates the entire translation process to ensure quality and consistency.
This is especially important in medical translation, where terminology accuracy and subject-matter expertise are essential.
Key requirements of ISO 17100
Qualified medical translators
According to ISO 17100, translators must have:
- A degree in translation, OR
- A degree in another field plus professional translation experience, OR
- Extensive professional experience in translation
In medical projects, this also means specialist knowledge in healthcare, pharmaceuticals or life sciences.
Mandatory revision process
Every translation must be reviewed by a second qualified linguist. This bilingual review compares the source text with the translated version to detect possible errors or inconsistencies.
Project management and quality control
Dedicated project managers coordinate each stage of the workflow and ensure that all client instructions, terminology and style requirements are followed correctly.
How Okodia applies ISO 17100 in medical translation
At Okodia, we work with specialised medical translators experienced in areas such as:
- Clinical research
- Pharmaceuticals
- Biotechnology
- Medical devices
- Healthcare communication
Each project follows a structured workflow:
- Project analysis
- Translation
- Bilingual revision
- Proofreading if necessary
- Final quality control
- Delivery and follow-up
We also use specialised translation management systems that allow us to monitor deadlines, terminology consistency and project status in real time.
Confidentiality and data protection in medical projects
Medical translation frequently involves confidential patient or clinical information. For this reason, our workflows include strict confidentiality measures and secure data handling procedures aligned with ISO requirements.
ISO 18587: Quality assurance in machine translation post-editing
What is ISO 18587?
ISO 18587 is the international standard that regulates machine translation post-editing services.
In medical translation, machine translation can help accelerate workflows for large volumes of content. However, human post-editing remains essential to guarantee accuracy, clarity and compliance.
Why human post-editing is critical in healthcare translation
Machine translation alone cannot fully understand:
- Medical terminology nuances
- Regulatory language
- Contextual meaning
- Patient safety implications
- Scientific precision
ISO 18587 establishes strict quality requirements to ensure that post-edited translations reach professional publication standards.
ISO 18587 requirements
Qualified post-editors
Post-editors must:
- Meet ISO 17100 translator requirements
- Be trained in machine translation post-editing
- Understand CAT tools and MT engines
- Identify typical machine translation errors
Prior text analysis
Before starting a project, the content must be analysed to determine whether machine translation is suitable for the text type, language pair and quality expectations.
Performance monitoring
Post-editors evaluate:
- Translation fluency
- Terminology accuracy
- Number of corrections required
- Overall machine translation quality
This helps improve future MT performance and workflow efficiency.
How Okodia applies ISO 18587 in medical translation
At Okodia, all medical post-editing projects are handled by qualified linguists specialised in healthcare translation.
Before applying machine translation, we assess:
- Medical complexity
- Terminology density
- Regulatory sensitivity
- Risk level of the content
Where appropriate, we also optimise source content beforehand to improve machine translation output and reduce post-editing effort while maintaining quality standards.
ISO 9001: Continuous quality management in translation services
What is ISO 9001?
ISO 9001 is the world’s leading quality management standard. It defines how organisations should structure processes to improve efficiency, consistency and customer satisfaction.
For medical translation providers, this means implementing controlled workflows and continuous quality improvement systems.
Main principles of ISO 9001
ISO 9001 focuses on:
- Customer satisfaction
- Continuous improvement
- Risk management
- Process optimisation
- Data-driven decision making
How Okodia applies ISO 9001
At Okodia, we maintain a secure internal management system where we document:
- Translation workflows
- Client preferences
- Terminology requirements
- Incident management procedures
- Corrective and preventive actions
This allows us to continuously optimise our medical translation services and ensure consistent quality across all projects.
Why ISO-certified medical translation matters
Choosing an ISO-certified medical translation agency offers several advantages:
- Greater linguistic accuracy
- Improved patient safety
- Regulatory compliance
- Consistent terminology management
- Confidential handling of sensitive data
- Verified quality assurance processes
For healthcare companies, pharmaceutical laboratories, CROs and medical device manufacturers, working with certified providers helps reduce risk and improve communication reliability.
Frequently asked questions about ISO standards in medical translation
What is ISO 17100 used for?
ISO 17100 defines the quality processes translation agencies must follow to deliver professional translation services.
What is ISO 18587 used for?
ISO 18587 regulates machine translation post-editing processes to ensure reliable human-reviewed translations.
What is ISO 9001 used for?
ISO 9001 establishes quality management systems focused on continuous improvement and customer satisfaction.
Why are ISO certifications important in medical translation?
Because medical content requires maximum accuracy, consistency and confidentiality. ISO standards help ensure that translation providers follow internationally recognised quality procedures.
Does machine translation replace medical translators?
No. Human medical translators and post-editors remain essential to ensure terminology accuracy, regulatory compliance and patient safety.
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