Nonconformance不符合项
A nonconformance is a failure to meet a specified requirement, standard, or procedure, including deviations in products, processes, documentation, supplier materials, equipment, or records. In translation and localization, it appears in quality event reports, CAPA records, audit findings, and supplier complaint files that document what went wrong, how it was classified, and what corrective and preventive actions were taken and verified.
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
Nonconformance terminology appears in quality management system documentation, internal and external audit reports, supplier corrective action requests, and CAPA investigation summaries. Translators must use the client’s approved QMS terms consistently and must not soften the wording, because the classification of a nonconformance affects investigation and escalation.
Translation checks
A frequent error is translating nonconformance as a synonym for “defect” or “complaint,” which may be narrower or broader than the quality-system meaning. That can change how a deviation is recorded and prioritized, making audit responses look inconsistent or causing a CAPA to be opened at the wrong level.
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.