In many regulated organizations, translation is still treated as a low-impact operational task. It is hired when a one-off need arises, measured by speed and cost, and evaluated only when something goes wrong. The problem is that in environments where quality, traceability and compliance are critical, translation is not an add-on. It is a direct risk or control factor.
When a regulatory document, an internal procedure or a communication with authorities is translated without professional criteria, the risk is not only in the language. It is in the interpretation, in the consistency of terminology, in the correct version of the document and in the ability to demonstrate how that content was produced. This impacts audits, inspections and compliance processes silently but constantly.
Quality and compliance know this well. A translation error can lead to audit observations, delays in approvals or even the invalidity of a key document. But beyond the specific error, the biggest risk is the lack of a system. Without defined processes, version control and traceability, the organization loses control over its own multilingual information.
Therefore, in regulated companies, professional translation must be understood as part of the management system. Not as an isolated external service, but as a process that is integrated into the quality, documentation and internal control flows. This change of approach makes the difference between reacting to problems and preventing them.
ISO 17100 sets out clear requirements for translation processes, from translator competence to independent review and project management. Its value is not in the label, but in the operational discipline it introduces. Applying these criteria reduces variability, ensures consistency and demonstrates control to third parties. In regulatory contexts, this is a concrete form of risk mitigation. For more information, you can consult the standard at https://www.iso.org/standard/59149.html.
In the operational practice of companies like yours, it is common to find critical translations managed by multiple vendors, with no centralized memories or validated glossaries. Each new project starts from scratch, increasing the risk of inconsistencies. When this happens, translation ceases to be a support and becomes a source of uncertainty.
Integrating professional translation into the quality system involves defining clear criteria: who translates, how it is reviewed, how it is approved and how evidence of the process is retained. It also involves aligning this process with other management standards, such as ISO 9001, which promotes a process-based approach and continuous improvement. More information on this standard is available at https://www.iso.org/standard/62085.html.
This approach does not seek to make the operation more complex, but rather to give it stability. When translation is managed as a critical process, the quality and compliance areas gain visibility, predictability and confidence. Dependence on improvised solutions is reduced and operational continuity is strengthened.
The beginning of the year is a good time to review these points. Not from the point of view of urgency, but from the point of view of strategy. Asking yourself if the translation is aligned with the control levels required by your industry is a first step to reduce risks that often go unnoticed.
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