# Conformity Assessment

> Conformity assessment is the formal process of demonstrating that a high-risk AI system meets the requirements of the EU AI Act before being placed on the market or put into service.

Category: Methodology
Source: https://impetora.com/glossary/conformity-assessment
Part of: Impetora AI consulting glossary (https://impetora.com/glossary)

## What is Conformity Assessment?

Conformity assessment for high-risk AI involves technical documentation (Annex IV), risk management, data and data governance evidence, testing records, human-oversight design, accuracy and robustness measurement, cybersecurity controls, and a quality management system. Most high-risk systems can self-assess; some require notified body involvement. The output is a CE marking and an EU declaration of conformity.

## How does Conformity Assessment apply to enterprise AI?

Enterprises building or procuring high-risk AI need a conformity assessment plan from day one. The artefacts overlap heavily with ISO 42001 and ISO 27001 evidence and can be produced once and reused.

## Related terms

- [EU AI Act](https://impetora.com/glossary/eu-ai-act) - The EU AI Act (Regulation (EU) 2024/1689) is the European Union's horizontal regulation for AI, classifying systems by risk and imposing obligations on providers, deployers, importers, and distributors.
- [ISO 42001](https://impetora.com/glossary/iso-42001) - ISO/IEC 42001 is the international standard for AI management systems, specifying requirements for establishing, implementing, maintaining, and continually improving an AI governance programme.
- [AI Risk Management](https://impetora.com/glossary/ai-risk-management) - AI risk management is the discipline of identifying, assessing, mitigating, and monitoring the harms an AI system can cause across its lifecycle.
- [TRACE Methodology](https://impetora.com/glossary/trace-methodology) - TRACE is Impetora's four-pillar methodology for delivering enterprise AI in regulated industries: Trust, Readiness, Architecture, Citations.

## External references

- [EU AI Act Annex IV](https://eur-lex.europa.eu/eli/reg/2024/1689/oj)

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