Course description

This course provides in-depth guidance on implementing ISO/IEC 42001:2023, the first international management system standard for Artificial Intelligence (AI). Designed for organizations that develop, deploy, or use AI systems, ISO 42001 sets out a framework for responsible AI governance, risk management, transparency, and continuous improvement. Participants will learn how to operationalize AI ethics, manage lifecycle risks, and align with evolving regulatory expectations.

What You’ll Learn

By the end of the course, you will be able to:

• Understand the scope, terminology, and structure of ISO/IEC 42001:2023.

• Establish and maintain an AI Management System (AIMS) aligned with organizational strategy.

• Apply principles of trustworthy and responsible AI across the lifecycle.

• Conduct AI-specific risk assessments, impact assessments, and conformity evaluations.

• Define accountability, roles, and oversight structures for AI governance.

• Implement controls for data quality, bias mitigation, explainability, and traceability.

• Align AIMS with legal, regulatory, and ethical frameworks (e.g., EU AI Act, OECD AI Principles).

• Monitor AI system performance, incidents, and continual improvement mechanisms.

• Integrate AI governance into existing management systems (e.g., ISO 27001, ISO 9001).

• Prepare for internal audits or third-party certification of AI governance systems.

Who Should Attend

• AI Project Leaders and Data Scientists

• Chief AI Officers and Tech Governance Teams

• Compliance, Risk, and Ethics Officers

• CTOs, CIOs, and Digital Transformation Leaders

• AI Solution Developers and Product Managers

• Legal, Regulatory, and Quality Professionals in AI fields

• Consultants in AI governance, trust, and auditing

Recommendations

• Familiarity with AI system development, ML models, or data governance is helpful

• No prior ISO 42001 experience is required

• Strong fit for organizations building or deploying high-impact AI application

Course Description

This course equips participants with the knowledge and skills to perform effective internal audits of a Quality Management System (QMS) in accordance with ISO 13485:2016. Designed for organizations involved in the medical device lifecycle, the training focuses on assessing conformity with the standard’s requirements, regulatory expectations, and risk-based controls. It also integrates ISO 19011 audit principles and provides practical techniques for planning, executing, and reporting internal audits that support certification and continual improvement.

What You’ll Learn

By the end of the course, you will be able to:

• Understand the structure and key requirements of ISO 13485:2016.

• Explain the internal audit process based on ISO 19011:2018.

• Plan internal audits based on process, risk, and regulatory focus areas.

• Develop audit checklists and gather objective evidence through records and interviews.

• Assess implementation of procedures, documentation, traceability, and control of outsourced processes.

• Identify nonconformities and generate clear, actionable audit findings.

• Write professional audit reports and communicate results to stakeholders.

• Follow up on corrective actions and verify effectiveness.

• Contribute to continual improvement and readiness for regulatory inspections or certification audits.

• Evaluate supplier audits and integration into the internal audit program.

Who Should Attend

• Internal Auditors in medical device organizations

• QMS Coordinators and Quality Assurance Staff

• Regulatory Compliance Officers

• Manufacturing and Operations Managers

• Design and Development Engineers

• Consultants supporting ISO 13485 compliance

Recommended

• Familiarity with ISO 13485:2016 or your organization’s medical device QMS is helpful

• No prior internal audit experience is required

• Basic understanding of medical device regulatory context is beneficial

Course Description

This course provides in-depth knowledge of the ISO 13485:2016 standard, designed specifically for organizations involved in the life cycle of medical devices. It guides participants through the structure and requirements of the standard and shows how to implement an effective Quality Management System (QMS) that ensures product safety, regulatory compliance, and customer satisfaction. The training emphasizes risk management, regulatory requirements, process controls, and documentation practices aligned with medical device industry expectations.

What You’ll Learn

By the end of the course, you will be able to:

• Explain the purpose, structure, and clause requirements of ISO 13485:2016.

• Define the QMS scope and apply a process-based approach for medical device organizations.

• Understand risk management principles specific to medical device manufacturing and supply.

• Interpret and implement regulatory requirements within the ISO 13485 framework.

• Establish documentation, procedures, and controls for design, production, and traceability.

• Set up effective monitoring, measurement, and CAPA processes.

• Define roles, responsibilities, and training requirements for QMS support.

• Integrate supplier control and outsourcing management.

• Prepare documentation and records to demonstrate conformity and certification readiness.

• Build a roadmap for ISO 13485 implementation across the organization.

Who Should Attend

• Quality Managers and QMS Coordinators in medical device companies

• Regulatory Affairs Specialists

• Design and Manufacturing Engineers

• Internal Auditors and Compliance Officers

• Consultants supporting ISO 13485 implementation

• Any staff involved in medical device lifecycle management

Recommended

• Understanding of your organization’s medical device processes is helpful

• No prior ISO experience is required

• Familiarity with regulatory or technical documentation is beneficial

Course Overview

This hands-on course provides the knowledge and tools to implement a Quality Management System (QMS) in alignment with ISO 9001:2015. You’ll explore the standard’s structure and principles, learn to interpret and apply its requirements, and build practical systems to manage quality performance, risks, and customer satisfaction. The course maps all activities to clauses 4 through 10 of ISO 9001, enabling participants to translate requirements into an operational QMS tailored to organizational needs.

What You’ll Learn

By the end of the course, you will be able to:

• Explain ISO 9001:2015 structure, key principles, and clause requirements (4–10).

• Analyze the organization’s context and interested parties to define QMS scope.

• Identify quality risks and opportunities and integrate them into the QMS.

• Set quality objectives and KPIs aligned with strategic direction.

• Establish operational processes, controls, and documented procedures.

• Define roles, responsibilities, and support mechanisms (competence, awareness, communication).

• Build internal audit, management review, and corrective action routines.

• Understand the PDCA (Plan-Do-Check-Act) cycle within the QMS framework.

• Prepare a step-by-step roadmap for ISO 9001:2015 implementation.

• Collect evidence to demonstrate conformity and certification readiness.

Who Should Attend

• Quality Managers and QMS Coordinators

• Operations Managers and Department Heads

• Internal Auditors and Compliance Officers

• Process Owners and Document Controllers

• Consultants supporting ISO 9001 implementations

• Any staff involved in QMS development, implementation, or transition

Recommended

• Familiarity with your organization’s processes and structure

• No prior ISO experience required

• Understanding of basic process and performance metrics is helpful