ISO 13485质量管理体系
ISO 13485 is an international standard that specifies quality-management-system requirements for organizations involved in the design, production, installation, and servicing of medical devices. In life-science translation, it is referenced in quality manuals, audit checklists, supplier agreements, and certificates; translators must keep its process terms consistent because the standard underpins regulatory compliance across multiple markets and languages and is often a condition for market access.
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
ISO 13485 terminology occurs in quality-system localization, audit preparation, and supplier qualification projects. Translators often work with terms like design control, document control, traceability, and CAPA, and must align them with corporate quality glossaries because auditors compare translated procedures across sites and languages during certification or surveillance audits and supplier reviews.
Translation checks
A common mistake is translating ISO 13485 process names literally without checking how they are used in an organization’s quality system. Terms such as 'document control' and 'design control' can sound like general administration if rendered loosely, which can disconnect translated procedures from the standard’s intended controls and create audit findings.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishQuality manuals, SOPs, production-process and clinical-trial documentation.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.