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ISO/IEC 42001 – Artificial Intelligence Management System

Show your quality compliance with the requirements in the pharmaceutical industry and open the door to new opportunities.

Key benefits of
ISO/IEC 42001

  • How to establish the artificial intelligence management system according to ISO/IEC 42001?
    Establishing ISO/IEC 42001 — the international standard for artificial intelligence management systems — involves several key steps:

    1. Understand ISO/IEC 42001 Requirements
      Study the scope, clauses, and controls of ISO/IEC 42001, focusing on governance, risk, and lifecycle management.
    2. Define Organizational Context & Scope
      Identify AI use cases, stakeholders, regulatory obligations, and define which AI systems the AIMS covers.
    3. Secure Leadership Commitment
      Top management must approve AI policy, assign responsibilities, allocate resources, and promote responsible AI culture.
    4. Establish AI Governance Structure
      Create roles, committees, and accountability for AI ethics, compliance, risk ownership, and decision-making.
    5. Perform AI Risk Assessment
      Identify risks related to bias, transparency, safety, security, privacy, and misuse across the AI lifecycle.
    6. Define Controls & Processes
      Implement documented procedures for:
      • AI design and development
      • data management and quality
      • model validation and testing
      • deployment, monitoring, and change management
    7. Integrate Ethical & Legal Principles
      Ensure fairness, explainability, human oversight, and alignment with applicable AI laws and regulations.
    8. Train Employees & Build Awareness
      Provide role-based training so teams understand AI risks, responsibilities, and AIMS requirements.
    9. Monitor, Measure, and Audit
      Track AI performance, incidents, and compliance; conduct internal audits and management reviews regularly.
    10. Improve Continuously & Prepare for Certification
      Address nonconformities, improve controls, and engage an accredited certification body when ready.

Tadej Borštnar

Already established and certified management systems are my guarantee for your success