Recommended ISO certifications for medical translation agencies

Published on 14/04/2023

In the field of medical translation, the quality, accuracy and consistency of translations are key factors when it comes to ensuring patient safety. That is why agencies working with medical translators must adhere to strict standards to ensure quality translations. 

In this article we will discuss three key ISO standards for medical translation agencies : ISO 17100:2015, ISO 13485:2016 and ISO 9001.

What is a ISO declaration of conformity?

An ISO certification (ISO stands for International Organization for Standardization) is an official recognition given to a company by an independent third-party certification body for the successful implementation of ISO standards.

ISO standards are international standards that establish requirements and guidelines for different management systems.

Through these certifications, companies can demonstrate their commitment to internationally recognised quality standards and good management practices. 

Third-party certification bodies conduct regular audits to verify that the organisation continues to comply with ISO standards and to renew certification.

ISO certifications can offer several benefits to companies, such as improved efficiency, reduced costs, increased customer and employee satisfaction, regulatory compliance and improved brand image.

The ISO 17100:2015 standard

Wondering what ISO 17100:2015 is? We will explain it to you!

ISO 17100:2015 specifies the requirements for translation services, including the skills required for translators, the translation and revision processes, and the tools and technologies used to ensure the quality of translations.

This standard is also essential for translation agencies seeking to ensure the quality and accuracy of their translations, particularly for projects involving the translation of sensitive medical documents such as medical reportspatient records and medical device manuals.

But what are the requirements specified by this standard for medical translation agencies?

One of the particularities of this standard is that it requires a review of the translation by a second professional.

Its requirements also include a high level of language skills, a thorough knowledge of the medical field and cultural aspects, and significant professional experience as a medical translator. In addition, translators carry out specialised translations into their mother tongue to ensure the quality of the final output.

For this reason, ISO 17100 certified translation agencies are considered to have a high level of translation competence, which gives them a competitive advantage over non-certified translators.

The ISO 13485:2016 standard

Now that you know about ISO 17100:2015, let us tell you more about ISO 13485:2016.

ISO 13485:2016 specifies the requirements for the quality management system (QMS) of medical devices.

It is applicable to manufacturers of medical devices, but also to providers of services related to medical devices, such as medical device translation services

This standard aims to ensure the quality and safety of medical devices throughout their life cycle, from design and development to production, distribution and after-sales service. It includes requirements for documentation management, process validation, traceability and risk management.

Its requirements also include high quality translation and editing processes that ensure consistency and accuracy of translations.

It allows for a demanding procedure towards the control of translators, paying attention to their professional references and specialisation in the medical field. 

The auditors of the Notified Bodies highly value those translation companies certified under the ISO 13485 standard as a guarantee of their commitment to quality and security in the translation of medical documents.

The ISO 9001 standard

Last but not least, we will explain the ISO 9001 standard.

This standard specifies the requirements for the quality management system in all types of companies. 

Although not specific to medical translation, it is relevant here because it requires the implementation of a quality management system that ensures customer satisfaction and the consistent quality of products and services provided.

The quality, accuracy and consistency of medical translations are essential to ensure patient safety. Poorly done translations can have serious consequences for patients' health.

Companies wishing to use ISO 9001 certified translation agencies can be assured that the translation and revision processes meet the highest quality standards.

Clients can therefore have confidence in the quality of the professional translations provided by these translators, which can be a competitive advantage for those seeking to establish their reputation in this field.

Conclusion: essential certifications for medical translation agencies

In conclusion, we can say that ISO 17100:2015, ISO 13485:2016 and ISO 9001 are all essential for medical translation agencies

The strict requirements for these standards guarantee the qualityaccuracy and safety of medical translations. 

The ISO certifications of translation providers are a proof of the commitment of the economic operators regarding the quality of translations vis-à-vis the auditors of Notified Bodies. 

If you want a medical translation that meets these standards, we advise you to rely on translation agencies certified according to these 3 standards. 

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Emeline PADIEU's picture
Emeline PADIEU

Emeline holds a Master's degree in Applied Foreign Languages, specialising in International Management and International Trade Techniques. She completed her end-of-studies internship at AbroadLink Translations and now works there as a sales and marketing assistant

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