AI Compliance Checklist - Manufacturing Edition

Overview

Manufacturing AI compliance spans three domains: safety regulations that protect workers and equipment, quality standards that ensure product integrity, and emerging AI-specific laws that govern how AI systems are developed and deployed. Each domain has different regulators, different requirements, and different consequences for non-compliance.

This comprehensive checklist integrates all three domains into a unified compliance approach. It covers what regulations apply to different manufacturing AI use cases, what each requires, and how to satisfy multiple frameworks efficiently.

What's Inside

• Manufacturing AI Regulatory Map: Overview of which regulations apply to different AI use cases (predictive maintenance, quality inspection, robotics, process control)
• Safety Compliance Checklist: OSHA requirements for AI-controlled equipment, EU Machinery Regulation compliance, and risk assessment requirements for AI in safety-related functions
• Quality Standards Compliance: ISO 9001 requirements for AI in quality systems, IATF 16949 for automotive, AS9100 for aerospace, and documentation requirements
• Machine Safety Standards: ISO 12100 (risk assessment), ISO 13849 (safety-related control systems), and requirements for AI integrated with safety functions
• Industry-Specific Compliance: Additional requirements for automotive (IATF 16949), aerospace (AS9100), food manufacturing (FSMA, HACCP), and pharmaceutical (FDA 21 CFR Part 11)
• EU AI Act for Manufacturing: High-risk classification for manufacturing AI, conformity assessment requirements, and safety component provisions
• Environmental Compliance: AI in environmental monitoring and reporting, emissions controls, and sustainability
• Cybersecurity Compliance: IEC 62443 requirements for manufacturing AI, OT security standards, and network segmentation
• Documentation Requirements: What auditors expect for manufacturing AI including validation records, risk assessments, and change control
• Audit Preparation Guide: Preparing for ISO certification audits, customer audits, and regulatory inspections

Who This Is For

• Manufacturing CIOs/CTOs deploying AI across operations
• Quality Directors maintaining ISO certification with AI
• Safety Officers ensuring AI complies with safety regulations
• Compliance Managers managing regulatory requirements
• Automation Engineers implementing compliant AI systems

Why This Resource

Manufacturing compliance is fragmented across safety regulators, quality certification bodies, and now AI-specific laws. This checklist unifies these requirements—showing how to satisfy multiple frameworks with efficient, integrated controls.

Industry-specific sections ensure you address the additional requirements for your sector (automotive, aerospace, food, pharma) beyond baseline manufacturing compliance.

FAQ

Q: Does OSHA regulate AI specifically?

A: OSHA doesn't have AI-specific regulations, but general duty clause requirements apply to AI-controlled equipment. The safety section covers how to satisfy OSHA requirements for manufacturing AI including risk assessment and safeguarding.

Q: How do ISO quality standards apply to AI?

A: ISO 9001 and sector standards (IATF 16949, AS9100) require documented validation of any process affecting quality—including AI. The quality section covers how to document AI validation, maintain process control, and satisfy auditor expectations.

Q: What about EU AI Act for manufacturing?

A: Manufacturing AI may be classified as high-risk under EU AI Act, particularly AI in safety components or quality-critical applications. The EU AI Act section covers classification and conformity requirements.