Artificial Intelligence Sector
Artificial Intelligence Testing, Certification and Conformity
Overview
Artificial Intelligence sector: an overview of conformity processes
The first international management system standard for AI governance is ISO/IEC 42001 (2023). The EU AI Act imposes obligations by risk class; 42001 provides a governance framework that supports these obligations but does not substitute for conformity assessment.
How we work
Six steps from scope to certificate
Scope
We determine your product, target market and sector; the required legislation list is produced.
Quote
Testing and audit items are priced separately; the quote is delivered within 24 hours.
Sample / Planning
Sample requirements are shared, or an on-site audit is scheduled.
Testing & Audit
Testing or audit is carried out according to the method of the relevant standard.
Report & Document
A report is issued; if within certification scope, the process proceeds to the decision stage.
Maintaining the validation
Surveillance audits and legislative changes are tracked.
Product groups
Artificial Intelligence sector: what do we test?
- 01AI models and platforms
- 02Decision support and forecasting systems
- 03Image and audio processing solutions
- 04Medical device software containing AI
- 05Autonomous system components
Services
The work we carry out in this sector
From testing laboratories to inspection, surveillance, audit, verification and calibration — all the services the Artificial Intelligence supply chain needs are under one roof.
All services
Standards
Standards referenced by the sector
Content is linked to standards based on the product's intended use, target market and technical characteristics.
- ISO 11607end product sterile barrier packaging
- ISO 11737-1determination of microbial load in medical devices
- ASTM F1980accelerated aging in packaging
- ASTM F88peeling resistance in sealing seam
- IEC 60601-1Basic safety in medical electrical devices
- IEC 60601-1-2electromagnetic compatibility in medical electrical devices
- IEC 62304medical device software lifecycle processes
- IEC 62366-1usability engineering in medical devices
- ISO 10993-10skin sensitivity assessment
- ISO 10993-11systemic toxicity
- ISO 10993-23irritation assessment
- ISO 10993-3genotoxicity, carcinogenicity and reproductive toxicity
- ISO 10993-4evaluation of interaction with blood
- ISO 10993-5in vitro cytotoxicity
Certification
Documents that enable your product to reach the market
Global Market Access
Artificial Intelligence which market will you offer your product to?
Artificial Intelligence when offering products to different markets, technical legislation, tests, documents and conformity requirements may vary by country and region.
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