- Why translation standards exist
- ISO 17100: the central reference for professional translation services
- Other standards with direct impact on technical translation
- What to check when commissioning certified technical translation
- M21Global and technical document translation
- Related Services
- Frequently Asked Questions
Anyone commissioning or managing technical document translation in an international context will at some point need to understand the standards that apply. The regulatory framework is not a single rule but a set of overlapping requirements that affect the translation process in different ways depending on the sector, the document type, and the target market.
Why translation standards exist
Translation standards do not define what constitutes a good translation in linguistic terms. They define processes, competency requirements, and quality controls that translation service providers must follow. The underlying logic is the same as any industrial quality standard: to ensure the output is consistent, traceable, and fit for purpose.
For technical documentation, this matters more than in most other content types. A mistranslated operating manual can create safety risks. An inconsistent maintenance procedure can lead to costly errors on the factory floor. Standards provide a systematic way to reduce these risks, and they give buyers a basis for evaluating and comparing providers.
ISO 17100: the central reference for professional translation services
ISO 17100:2015 is the most widely recognised standard for professional translation services. It specifies requirements for the core processes of a translation project: translator qualifications, the revision process, project management, and the use of translation technology.
The most consequential requirement is independent revision. All translation work performed under ISO 17100 must be reviewed by a second qualified linguist who was not involved in the original translation. This is not optional: it is a compliance requirement. For high-stakes technical documentation, such as instructions for use for medical devices, safety data sheets, or installation manuals for critical systems, this requirement has direct implications for quality and for the provider's accountability.
ISO 17100 certification from a provider may also be required as a contractual condition in public procurement or in industrial supply chains that demand traceable documentation.
Other standards with direct impact on technical translation
Beyond ISO 17100, several other standards affect technical document translation depending on the sector and document type.
IEC 82079-1 is the international standard for the preparation of instructions for use of products. Although primarily directed at technical writers, it has clear implications for translation: it defines requirements for structure, completeness, and target-audience appropriateness that apply equally to translated versions. A translated user manual that does not meet the principles of this standard may be considered non-compliant even if the original does.
ISO 18587:2017 governs the post-editing of machine translation output by human translators. It defines competencies and processes for projects where machine translation is used as a starting point and a human translator reviews and corrects the output. This standard is particularly relevant for large volumes of technical documentation where turnaround time is a critical factor.
EN 15038 was the European predecessor to ISO 17100 and was formally superseded by it in 2015. It may still appear in older contracts, but it is no longer the active normative reference.
Sector-specific regulations add further layers. In the medical sector, EU Regulation 2017/745 (MDR) imposes precise requirements on the translation of instructions for use and device labelling. In the chemical sector, the REACH Regulation and the GHS system determine the content and presentation of safety data sheets in each target language. These regulations do not replace translation standards but complement them with content-specific obligations.
What to check when commissioning certified technical translation
Understanding the standards is useful. Knowing what to verify before awarding a project is what matters in practice.
- Active ISO 17100 certification: confirm the certification is current and issued by an accredited body. Self-declaration of compliance is not equivalent.
- Translator qualifications: ISO 17100 requires translators to hold a relevant higher education qualification in translation or a combination of equivalent academic training and documented experience in the relevant technical field.
- Revision process: confirm the workflow includes independent review by a second linguist, not just self-review by the translator.
- Terminology management: technical documentation projects benefit from controlled glossaries and translation memories. Ask whether these resources are created and maintained throughout the project.
- Traceability: in regulated sectors, it may be necessary to retain records of the translation process for audit purposes. Check whether the provider can supply this documentation.
For a concrete overview of what professional technical translation involves in practice, the M21Global technical translation service page covers the document types handled and the process applied.
M21Global and technical document translation
M21Global has been working with technical documentation for over 20 years and holds ISO 17100:2015 certification issued by Bureau Veritas. The process includes independent revision on all projects requiring compliance with this standard, as well as glossary and translation memory management by technical domain. For projects with sector-specific requirements, such as medical device documentation or safety data sheets, the team has direct experience with the applicable regulations.
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Frequently Asked Questions
What is ISO 17100 and why does it matter for technical translation?
ISO 17100:2015 specifies process requirements for professional translation services, including translator qualifications, mandatory independent revision, and project management controls. For technical documentation, it ensures consistent quality and provides a traceable audit trail.
Is ISO 17100 certification legally required for technical document translation?
It is not a general legal requirement, but it may be mandated as a contractual condition in public procurement or industrial supply chains. In regulated sectors such as medical devices, the quality obligations imposed by sector regulations are broadly equivalent in practice.
What is the difference between ISO 17100 and ISO 18587?
ISO 17100 covers human professional translation processes. ISO 18587 covers the post-editing of machine translation output by human translators, defining the competencies and workflow requirements for projects that use machine translation as a starting point.
Does IEC 82079-1 apply to translated versions of user manuals?
Yes. IEC 82079-1 defines requirements for instructions for use and applies to translated versions as much as to the source document. A translation that does not meet the structural and content requirements of this standard may be considered non-compliant.
What does ISO 17100-compliant technical translation require in practice?
It requires translation by a qualified linguist, independent revision by a second qualified linguist, a final quality check, and terminology and translation memory management. Self-revision by the translator alone is not sufficient for ISO 17100 compliance.
