Quality Management In Life Sciences Translation

by | Jul 2, 2020

Quality management is a key element of the translation and localization industry. It ensures that the translation keeps the original content and intended purpose.

According to ISO 9001:2015, quality is “the degree to which a set of inherent characteristics of an object fulfill requirements.” This means that the translated text must be accurate and error-free, meet the client’s requirements, and fit the purpose and target audience. In Life Sciences, this also means that translators must ensure that the final text complies with strict national and international regulations.

Quality is not just the product of a meticulous translation and proofreading process. Rather, it results from a well-designed quality management framework implemented from the very start of the translation project.

Quality Assurance vs Quality Control

Although often used interchangeably, quality assurance (QA) and quality control (QC) are two separate but complementary components of quality management.

QA is a proactive step that sets out the rules and standards to prevent non-conformities, whereas QC is a reactive step aimed at detecting potential non-compliance against these rules and standards.

A quality management system that includes systematic QA and QC criteria will result in a final text that meets all linguistic and regulatory requirements.

Key Aspects Of Quality Management

Translation quality management is based on four key aspects that all language service providers (agencies and freelancers) should observe:

1. Expertise
The translator’s expertise is the most important factor in translation quality. Here, qualifications and continuous professional development play a key role, particularly in a field marked by high standards and constant innovation, such as Life Sciences. Apart from language and translation skills, translators must be qualified and understand the subject matter, the purpose, and the target audience. Life Sciences translators may have a background in the Life Sciences field and, later on, specialize in translation, or may be trained in translation and subsequently choose to specialize in Life Sciences.

2. Three-Step Process (minimum)
Translation, editing, and proofreading – this is the basic methodology in the translation process. Even the “simplest” text should go through this standard process before being considered final. The translator produces the initial translation; the editor reviews the translated text against the source document; and finally, the proofreader checks the content for formatting, grammar, and punctuation errors.

Some projects may require additional steps. For example, in clinical trials, it is recommended to include a back-translation step (translating an existing translation into its original language) for informed consent forms and other documents to ensure that all translations are accurate.

3. Translation Technology
Computer-assisted translation (CAT) tools have certainly contributed to increasing productivity and quality. The use of translation memories, glossaries, and QA checkers allows translators to produce consistent and accurate texts more efficiently. These tools help to ensure that the whole text is translated in a consistent fashion using the correct terminology. However, without the necessary preparation steps, CAT tools cannot be used to their full extent. Before starting the translation task itself, translation memories should contain all relevant legacy texts, glossaries should list the most appropriate and relevant terms, and the QA/QC criteria should be set from the outset.

4. Workflow Automation
Traditional process management systems are error-prone. Recurrent tasks such as file management, assignment, and versioning control can be performed by a Translation Management System (TMS), allowing translators to focus on the translation task itself. Collaboration and communication features are also important since they allow all those involved in the translation steps to access the project files and specifications. A good TMS is of utmost importance during the preparation phase.

Quality And Safety

In Life Sciences, quality goes hand-in-hand with safety. When properly implemented from top to bottom in the translation process, a comprehensive quality management system will prevent poor translations that can jeopardize the whole product development process, compromise clinical data interpretation, or cause injury or worse of those involved.


Ana Sofia Correia

Translator & Language Consultant

Ana Sofia Correia is an English to Portuguese translator and language consultant. With over twelve years of experience, both as a freelance and in-house translator, she works with Medical and Life Sciences Companies and Clinical Research Organizations who need to have their clinical trial materials, product information, and questionnaires translated and validated into Portuguese. She also works with patient organizations to provide clear and accurate information to Portuguese-speaking patients, caregivers and healthcare professionals. 

There are several ways within Wordbee to manage translation quality and ensure the best outcome for your clients. Contact the Wordbee team to learn more.

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