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Pharmaceutical Translation: The Role of ISO 17100:2015 Certification

Medical Pharmaceutical Translations • Jun 3, 2024 11:48:00 AM

In the intricately woven tapestry of pharmaceutical translation, precision isn't just a preference; it's a prerequisite. Every word, every phrase carries immense significance, impacting patient safety, regulatory compliance, and global accessibility to life-saving medications. Amidst this demanding landscape, ISO certification emerges as a beacon of quality assurance, setting the stage for excellence and reliability. In this article, we'll explore the pivotal importance of ISO certification, with a special focus on ISO 17100:2015, in pharmaceutical translation companies.

ISO Certification: A Mark of Excellence

ISO (International Organization for Standardization) certification is synonymous with excellence, providing a framework for organizations to establish and maintain robust quality management systems. For pharmaceutical translation companies, ISO certification signifies a commitment to upholding the highest standards of quality, accuracy, and compliance. ISO certification serves as a testament to a company's dedication to meeting customer requirements, adhering to industry best practices, and driving continuous improvement.

Understanding ISO 17100:2015

ISO 17100:2015 is a specific standard tailored to the translation industry, focusing on the requirements for translation services providers (TSPs). It outlines the essential criteria for the provision of quality translation services, covering various aspects of the translation process, including:

  1. Competence of Personnel: ISO 17100:2015 emphasizes the importance of employing qualified translators and reviewers with expertise in both language and subject matter. It ensures that personnel possess the necessary linguistic skills, technical knowledge, and cultural understanding to deliver accurate and reliable translations.
  2. Quality Assurance Processes: The standard mandates the implementation of comprehensive quality assurance processes throughout the translation workflow. This includes measures such as translation memory usage, terminology management, proofreading, and revision to maintain consistency, accuracy, and coherence in translated content.
  3. Project Management Procedures: ISO 17100:2015 requires translation companies to establish efficient project management procedures to oversee translation projects from initiation to completion. This involves clear communication with clients, adherence to project timelines, and documentation of project specifications and requirements.
  4. Client Communication and Feedback: The standard emphasizes the importance of effective communication with clients and the solicitation of feedback to ensure alignment with client expectations and preferences. It encourages transparency, responsiveness, and collaboration to enhance customer satisfaction and service quality.

The Impact on Pharmaceutical Translation

ISO 17100:2015 certification holds particular significance for pharmaceutical translation companies due to the critical nature of the content they handle. By adhering to the requirements outlined in the standard, pharmaceutical translation companies can:

  • Ensure the accuracy and consistency of translated medical and scientific terminology, reducing the risk of errors and misunderstandings.
  • Enhance regulatory compliance by following standardized processes for document translation, localization, and quality assurance.
  • Foster trust and confidence among pharmaceutical clients and regulatory authorities, demonstrating a commitment to delivering reliable and high-quality translation services.
  • Drive continuous improvement and innovation within the organization, leading to greater efficiency, effectiveness, and customer satisfaction.


In the realm of pharmaceutical translation, where precision is paramount and stakes are high, ISO certification, particularly ISO 17100:2015, serves as a cornerstone of quality assurance. By adhering to the rigorous requirements outlined in the standard, pharmaceutical translation companies can uphold the highest standards of accuracy, reliability, and regulatory compliance. ISO 17100:2015 certification not only elevates the quality of translation services but also reinforces trust, credibility, and excellence in serving the global healthcare community.



Language access and its importance in the pharmaceutical industry

Language access refers to the provision of language services and resources to ensure that individuals with limited proficiency in the dominant language(s) of a given region can effectively communicate with healthcare providers, understand medication instructions, and access pharmaceutical products and services. It encompasses various forms of language support, including translation of written materials such as medication labels, package inserts, and patient information leaflets, as well as interpretation services for verbal communication during medical consultations and interactions.

Language access is crucial in the pharmaceutical industry for several reasons:

  1. Patient Safety: Clear and accurate communication between healthcare providers and patients is essential for ensuring patient safety. Inaccurate understanding of medication instructions due to language barriers can lead to medication errors, adverse drug reactions, and other safety concerns. Language access ensures that patients can understand dosage instructions, potential side effects, and other important information related to their medications.
  2. Regulatory Compliance: Regulatory agencies such as the FDA (Food and Drug Administration) in the United States and the EMA (European Medicines Agency) in Europe have stringent requirements for pharmaceutical labeling and patient information. These regulations often mandate the translation of medication labels and package inserts into multiple languages to ensure that patients can access vital information about their medications. Compliance with these regulations is essential for pharmaceutical companies to obtain regulatory approval and market their products effectively.
  3. Informed Consent in Clinical Trials: In multinational clinical trials, participants may come from diverse linguistic backgrounds. Providing informed consent requires clear communication of the study's purpose, procedures, risks, and benefits. Language access ensures that participants can fully understand the information provided in their preferred language and make informed decisions about participating in the clinical trial.
  4. Health Equity and Access to Care: Language barriers can disproportionately affect individuals from linguistic minority groups, immigrant communities, and non-native speakers of the dominant language. Language access promotes health equity by ensuring that all patients, regardless of their language proficiency, can access healthcare services, receive appropriate medical care, and understand their treatment options.
  5. Cultural Sensitivity: In addition to linguistic differences, cultural factors can also influence healthcare communication and decision-making. Language access initiatives often incorporate cultural competency training for healthcare providers to ensure respectful and culturally sensitive interactions with patients from diverse backgrounds.
  6. Pharmacovigilance and Adverse Event Reporting: Accurate reporting of adverse drug reactions and other medication-related events is essential for pharmacovigilance efforts. Language access ensures that patients can report adverse events in their preferred language, facilitating timely and accurate data collection and analysis.

In summary, language access is integral to promoting patient safety, regulatory compliance, health equity, and cultural competence in the pharmaceutical industry. By providing language services and resources, pharmaceutical companies and healthcare providers can ensure that all patients receive the information and care they need, regardless of their language background.



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