Timeline to Compliance: A Factory’s 12-Month Plan

The EU AI Act will be fully enforceable for high-risk AI systems by 2026. Manufacturers deploying AI in vision, robotics, or predictive maintenance must begin now to avoid penalties and production disruption. Here’s how to achieve full compliance in one year.

Month 1–2: Inventory and Classification

• List all AI or machine learning systems used in production, QA, logistics, and planning.
• Classify each as high-risk, limited-risk, or minimal-risk.
• Assign a compliance owner for each system.

Month 3–4: Gap Assessment

• Compare current documentation with AI Act Annex IV requirements.
• Assess data governance, explainability, and human-oversight readiness.
• Identify gaps in model traceability and post-market monitoring.

Month 5–6: Process and Policy Creation

Develop or update procedures covering:

• Data quality and bias detection.
• AI lifecycle management (training → validation → deployment).
• Incident reporting and fallback mechanisms.
• AI ethics and transparency statements.

Month 7–9: Conformity Assessment

• Prepare your technical documentation package.
• Engage internal or external auditors (Notified Body if required).
• Implement corrective actions for any non-conformities.

Month 10–12: Governance and Monitoring

• Finalize your AI governance framework.
• Register high-risk systems in the EU AI database.
• Set up continuous monitoring and retraining logs.

Case Example: Pharmaceutical Plant

A pharmaceutical manufacturer achieved AI Act readiness in 11 months by integrating model governance into its ISO 13485 QMS and creating automated traceability reports from its MLOps platform.

Related Articles

• EU AI Act for Manufacturing: Is Your Vision System ‘High-Risk’?
• Conformity Assessments for Industrial AI: Documentation That Passes
• AI Governance for Factories: Policies, Logs, and Human Oversight

Conclusion

Compliance with the EU AI Act requires planning, not panic. With a structured 12-month roadmap, manufacturers can integrate legal, technical, and governance requirements into existing quality systems — keeping innovation and compliance aligned.