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AI in Management Systems: Implementing ISO/IEC 42001:2023 in the Life Sciences

Artificial intelligence (AI) is a powerful tool, but its unique operation requires a specialized approach to risk management. This course introduces ISO/IEC 42001:2023, the new global standard for Artificial Intelligence Management Systems (AIMS). Life science organizations—including medical device and pharmaceutical manufacturers—must use AI responsibly to ensure product safety and efficacy. This training explains the standard and provides a clear roadmap for integrating AIMS activities with your existing Quality Management System (QMS). Throughout the course, active discussions will focus on identifying the objective evidence that auditors will seek to confirm your organization is meeting its responsible AI obligations.

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Brief Overview of this AI in Management Systems Training Class

SkillsLab Class ?

Class Content

In-Depth

Class Duration

4 Half-Days*

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person**

Certification of Completion

Yes

Continuing Education Units (CEUs)

1.6

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 2 consecutive days.
** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!
 
Upcoming Classes

Upcoming AI in Management Systems Training Classes

SkillsLab $2600

SkillsLab $2600

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
MAF VIRTUAL DELIVERY (Eastern time - PM) 08 Dec 2025 11 Dec 2025 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
MAF VIRTUAL DELIVERY (Eastern time - PM) 26 Jan 2026 29 Jan 2026 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
MAF VIRTUAL DELIVERY (Eastern time - PM) 23 Mar 2026 26 Mar 2026 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
MAF VIRTUAL DELIVERY (Eastern time - PM) 15 Jun 2026 18 Jun 2026 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
MAF VIRTUAL DELIVERY (Eastern time - PM) 14 Sep 2026 17 Sep 2026 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
MAF VIRTUAL DELIVERY (Eastern time - PM) 09 Nov 2026 12 Nov 2026 1:00PM - 5:00PM Eastern US Time Virtual REGISTER

GROUP DISCOUNT

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Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

What You Will Learn

This program is designed to provide you with the foundational knowledge and practical context needed to implement ISO 42001 effectively within a regulated Life Science environment:

  • Introduction to ISO/IEC 42001: Understand the structure, requirements, and intent of the new global standard for AI Management Systems (AIMS)
  • Responsible AI Principles: Explore the unique risks posed by AI and the organizational activities required to manage them effectively and ethically
  • QMS Integration: Learn practical methods for embedding ISO 42001 requirements into your existing GxP and ISO 13485 Quality Management Systems
  • Auditor Readiness: Identify key compliance documentation and objective evidence to demonstrate that your organization is using AI safely and responsibly
  • Product Safety & Efficacy: Discuss how to maintain the safety and effectiveness of products (drugs, devices) that utilize AI throughout their lifecycle
Course Overview
SkillsLab Class

Introduction to AI for Life Sciences

  • What is AI and how it is different from other tools?
  • AI system life cycle
  • Life science organization use cases
  • AI risks
  • AI governance in life science organizations
Exercise!: Assess Risks for Example Life Science AI Use Cases

Overview of ISO/IEC 42001:2023 for Life Science Organizations

  • Purpose and scope of ISO/IEC 42001
  • Overview of clauses and annexes
  • Applying ISO/IEC 42001 with other life science requirements and processes
Exercise!: Explain How ISO/IEC 42001 Supports Responsible AI

The Life Science Organization and Its Context

  • The organization and its context, including external and internal issues and the role of the organization
  • Interested parties
  • Scoping and setting up the AI management system
  • AI requirements roundup
Case Study!: Determine the Organization’s Context

The Leadership Responsibilities

  • Leadership and commitment activities
  • AI policy
  • Roles, responsibilities, and authorities
Case Study!: Apply Leadership Requirements

Planning Processes

  • Planning changes
  • Addressing risks and opportunities
  • Establishing AI objectives
  • Planning activities for the:
    • AI system impact assessment process
    • AI risk assessment process
    • AI risk treatment process
Case Study!: Apply Planning Requirements

Support Processes

  • Resources
  • Personnel competence
  • Awareness
  • Communication
  • Documented information
Case Study!: Apply Support Requirements

Operational Processes

  • Operational planning and control
  • Performing AI system impact assessments
  • Performing AI risk assessments
  • Implementing AI risk treatment plans
Case Study!: Apply Operation Requirements

Performance Evaluation

  • Monitoring, measurement, analysis, and evaluation
  • Internal audits
  • Management review
Case Study!: Apply Performance Evaluation Requirements

Improvement

  • Continual improvement
  • Nonconformities and corrective actions
Case Study!: Apply Improvement Requirements

Implementation Best Practices

  • Implementation success tips for life science organizations
  • Keeping up with AI technology and requirements
  • Ask the expert: Q&A
Exercise!: Identify Next Steps at Your Organization
What You Will Learn

What You Will Learn

At the conclusion of this training class, you will be able to
SkillsLab

Identify risks posed by AI use in life science organizations.

Describe the activities in ISO/IEC 42001:2023 that support responsible AI use.

Plan or participate in the implementation of ISO/IEC 42001:2023 at a life science organization.

Who Should Attend

Who Should Attend

This is an introductory course intended for personnel at life science organizations, including medical device and pharmaceutical manufacturers and suppliers. It is designed for individuals who will actively participate in the implementation, use, or oversight of the ISO/IEC 42001:2023 Artificial Intelligence Management System.

Note: Participants are expected to have a basic understanding of their organization's existing Quality Management System and to be familiar with ISO 13485 (for medical devices), ISO 9001, or Good Manufacturing Practices (GMPs) for pharmaceuticals. Specific Roles That Will Benefit:

  • QMS Implementation Team Members for AI initiatives
  • Quality Assurance (QA) & QMS Managers
  • Regulatory Affairs & Compliance Specialists
  • IT & Data Governance Managers
  • AI/Machine Learning (ML) Product Developers
  • Validation Engineers (especially those involved in Computer Systems Validation)
  • Individuals New to AI Governance and Risk Management
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