AI Quality Management System Policy Template

Structured 20-page policy framework providing a starting point for organizations developing QMS documentation for high-risk AI systems

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AI Quality Management System Policy Template

This policy template provides a foundational framework for organizations beginning their AI Quality Management System documentation. The 20-page template includes 16 pre-structured sections with placeholders and basic guidance for customization. Organizations will need to customize all bracketed sections, adapt content to their specific AI systems, and supplement with additional procedures and work instructions. This template serves as an organized starting point that can save several days of initial structure development.

What's Included ✓

• 20-page Word document with structured sections
• Placeholders marked for customization ([Company], [Product], etc.)
• Basic regulatory reference table
• Section headers aligned to ISO/IEC 42001 structure
• Quick start customization guide
• Version control and approval tables

Best Suited For:

• Organizations starting QMS documentation from scratch
• Teams needing a structural framework to build upon
• Companies seeking organized section templates
• Small to medium organizations with limited resources

What This Template Provides:

This template offers a structured starting point for AI Quality Management System documentation. It includes 16 main sections covering organizational context, leadership, planning, support, operations, performance evaluation, and improvement processes. Each section contains basic subsections and placeholder text that organizations must customize.

The document structure follows ISO/IEC 42001:2023 clause organization and includes references to EU AI Act requirements, particularly Article 17 on quality management systems. However, achieving actual compliance requires significant additional work beyond this template, including developing supporting procedures, training materials, and implementation evidence.

Framework References in Template:

• EU AI Act Article 17 structure considerations
• ISO/IEC 42001:2023 section alignment
• Basic regulatory mapping table included
• References to Articles 9, 27, and 61 of EU AI Act

What's Actually in the Document:

• Purpose and scope sections with placeholder text
• Organizational context framework (requires full customization)
• Leadership commitment section templates
• Basic risk assessment and treatment sections
• AI system lifecycle section headers
• Data management section outlines
• Performance evaluation structure
• Improvement process sections

Comparison Table: What's Included vs. What You'll Need to Add

FAQ Section

Q: Is this a complete QMS solution? A: No, this is a policy template that provides structure. You'll need to customize all content and develop supporting procedures, work instructions, and implementation tools.

Q: How much customization is required? A: Significant customization is needed. Every bracketed placeholder must be replaced, examples must be rewritten for your context, and sections must be adapted to your specific AI systems and organizational structure.

Q: Does this guarantee EU AI Act compliance? A: No, this template provides a documentation framework that may support compliance efforts. Actual compliance requires legal review, complete customization, and implementation of described processes.

Q: What expertise is needed to complete this template? A: You'll need understanding of your AI systems, organizational structure, quality management principles, and applicable regulations. Legal and compliance consultation is recommended.

Q: What format is provided? A: Documents are optimized for Microsoft Word to ensure proper formatting and collaborative editing capabilities.

Q: Are updates included? A: No, this is a one-time purchase of the current template version. Regulatory changes would require separate updates.

Ideal For:

• Quality managers needing structure to start documentation
• Small organizations without existing QMS frameworks
• Teams looking for organized section templates
• Consultants seeking base documentation structure
• Organizations with limited documentation budget
• Companies preferring to build internally from framework

Why This Price:

• Saves 2-3 days of structure research
• Costs less than 2 hours of consultant time
• Accessible for small organizations
• Fair value for starter framework

⚖️ Realistic Value Proposition

This policy template provides value as an organized starting framework for AI QMS documentation. Rather than beginning with a blank page, organizations receive a structured 20-page template with appropriate sections mapped to current AI governance standards. The primary value lies in the time saved researching proper QMS structure and understanding which sections to include.

The template requires substantial work to become a functioning QMS policy - all placeholders need customization, examples must be rewritten, and organizations need to develop their own procedures and controls. Think of this as purchasing the framework of a house rather than a move-in ready home. It provides the structure upon which you'll build your specific QMS documentation.

At $595, this template is priced appropriately for what it delivers: a well-organized starting point that can save several days of initial research and structure development, while being clear that significant customization work remains.