Certifications and standards in the translation of medical documents.
Certifications and standards in the translation of medical documents are a way to guarantee the quality of such translations. This quality is essential in the medical sector since a lack of precision in the communication between professionals, patients and regulatory bodies can generate a significant risk to people’s health.
Below, we analyze the main standards and certifications that regulate this discipline, their impact on the industry and how to ensure quality translations in medical documents.
Why are certifications and standards important in the translation of medical documents?
The accurate translation of medical documents is very important. Clinical reports, informed consents, trial protocols and scientific studies require precise terminology and an accurate understanding of the medical context. Certifications and standards in the translation of medical documents establish criteria that ensure quality, consistency and professionalism in these translations, minimizing the risks associated with misinterpretations.
These regulations are especially relevant for:
– Comply with international regulations in clinical research and pharmacology.
– Ensure patient safety through clarity of medical information.
– Facilitate the approval of medical devices and drugs by regulatory authorities.
Main certifications and standards in the translation of medical documents.
1. ISO 17100
ISO 17100 is one of the most recognized standards in professional translation, including medical translation. This certification establishes the requirements for translation service providers, covering aspects such as:
– Competence of translators and revisers.
– Quality control processes.
– Project and deadline management.
ISO 17100 ensures that translations of medical documents are performed by qualified professionals and reviewed by experts, minimizing critical errors.
2. ISO 13485
Although focused on medical devices, ISO 13485 impacts medical translation by setting requirements for equipment manufacturers in terms of multilingual documentation. Translated documents must meet the accuracy required by this certification to ensure their approval in international markets.
3. Good Translation Practices
Good Translation Practices are a set of guidelines adopted by the industry to ensure efficient work processes and high quality results. These practices include:
– Exhaustive review of translations.
– Terminology consistency through computer-assisted translation tools.
– Continuous evaluations of translators.
4. Compliance with regulatory standards
In addition to ISO certifications, it is important to comply with country-specific regulations, such as those of the FDA (Food and Drug Administration) in the United States or the EMA (European Medicines Agency). Medical documents must be translated and submitted in accordance with these requirements to ensure their legal and technical validity.
Benefits of working with certified medical translation providers.
– Quality assurance: Certifications and standards in the translation of medical documents ensure that the work meets the highest levels of accuracy.
– Risk reduction: Minimizes the possibility of costly errors that could affect the reputation or results of a medical project.
– Regulatory compliance: Facilitates the approval of clinical trials, medical devices and drugs in international markets.
– Process optimization: Certified suppliers use technologies and processes that streamline translation without sacrificing quality.
How to identify a certified medical translation service.
To ensure that you are working with a provider that meets the certifications and standards for medical document translation:
1. Verify your certifications: Requests evidence of ISO 17100, ISO 13485 or equivalent standards.
2. Evaluates the team’s experience: Make sure they have translators specialized in the medical field.
3. Reviews quality control processes: Ask if the translation includes revisions by a second professional.
4. Consult references and previous projects: A track record in certified medical translation is key to ensuring quality results.
Conclusion
Certifications and standards in the translation of medical documents are an essential guarantee in an industry that requires accuracy and reliability. Complying with international standards such as ISO 17100 and ISO 13485 not only ensures the quality of work, but also facilitates compliance with global regulations and protects the patients and professionals involved. Choosing certified translation services is an investment that minimizes risks and guarantees the success of any medical or scientific project.
