What a translation standard and a certificate cover
Translation standards describe service processes and quality systems. A certificate can provide evidence about those processes without guaranteeing the quality of the translated text.
Process standards and text quality
European standard EN 15038 was introduced in 2006, with a certification process that encouraged providers to advertise proprietary quality management methods. It regulated translation service requirements and the rights and obligations of clients and providers through a standardised process and measures supporting a sustainable working environment. As assessed in March 2012, it did not specify how to evaluate the quality of the translated text. A sound process is a prerequisite for high-quality output, but is neither a measure nor a guarantee of the quality of a particular translation. Even a robust process needs expert translators to produce accurate, readable and graceful text.
Some providers developed proprietary metrics, reportedly based on SAE J2450, described in 2012 as the only available standard for rating translation deliverables. These metrics identified obvious faults such as wrong meaning or terminology, omissions, additions and punctuation errors, but did not adequately assess style or register and were unsuitable where style mattered.
ISO 17100 and the agreed service
ISO 17100, “Translation services – Requirements for translation services”, sets out specifications for providing quality translations. A provider without certification may already fulfil many of its specifications and processes.
A medical translation agency's 2024 description associated ISO 17100 with three required steps: source-text analysis that allows translators to report potential problems, translation and revision. In that workflow, revision was described as essentially proofreading under the standard's terminology. The agency specified which standard the client wanted to work to when gathering the requirements for a new project.
Quality management standards
ISO 9001 is a generic quality management system standard applicable to any organisation. ISO 13485:2016, “Medical devices – Quality management systems – Requirements for regulatory purposes”, focuses more strongly on device safety, traceability and risk management. ISO 14971 addresses risk management for medical devices and helps companies systematically apply practices that reduce risk.