Lead Auditor ISO 13485 – MDQM

About ISO 13485:

The ISO 13485 Lead Auditor course for medical devices quality management system aims to provide participants with the knowledge and skills necessary to conduct and master the skills and techniques of effective auditing of the quality management system for medical devices in accordance with the audit guidelines according to this standard.. The course includes the following topics:

1. Understanding the Standard Requirements:

This section aims to provide a comprehensive understanding of the standards to be audited:

• Basic concepts and principles: The basic principles and concepts of service management and the planning, implementation, verification, and action cycle.
• The concept of a quality management system in medical devices.
• The importance of implementing the system in the medical device sector.
• Definition of the scope and importance.
• A detailed explanation of the requirements of the standard (e.g., context, leadership, planning, support, operation, performance evaluation, and improvement).
• The relationship between ISO 13485 and other management systems (e.g., ISO 9001).
• Background on the development of the standard and its importance in regulatory compliance.
• Regulatory requirements (e.g., FDA, CE, MDSAP).
• Basic concepts: risk, traceability, and process control.
• Product realization: planning, design and development processes, procurement, production, and service delivery.
• Identification of risks and opportunities and the actions required to address them…

2. Implementing a Medical Device Quality Management System

• Identifying internal and external stakeholder issues.
• Roles and responsibilities of senior management.
• Management and resource management responsibilities.
• Risk management: Integrating risk management principles (according to standards such as ISO 14971) into the medical device quality system.
• Identifying risks and opportunities, setting strategic objectives and policies.
• Resources, competencies, awareness, communication, and document control and purchasing.
• Design and development: Planning, inputs, outputs, review, and verification.
• Production and service delivery (process control, hygiene, process validation, definition, and traceability).
• Measurement, analysis, and improvement:
• Monitoring and measuring processes and products.
• Handling feedback and complaints.
• Operations (planning and controlling service delivery, service management processes such as incident management, problems, change, capacity, availability, service continuity, etc.).
• Nonconforming Product.
• Monitoring and Measurement, Internal Audit, Management Review.
• Nonconformity, Corrective Actions, and Continuous Improvement…

3. Audit Principles and Guidelines

This section focuses on the methodological foundations of the audit process:

• Definition and objectives of auditing.
• Principles of auditing: integrity, fair presentation, due professional care, confidentiality, independence, and an evidence-based approach.
• Types of auditing (systems, processes, compliance).
• Roles and responsibilities of auditors.
• Audit ethics (neutrality, objectivity, confidentiality).
• Qualities of a successful auditor.
• Ethical behavior during an audit.
• Managing opening and closing meetings.
• Dealing with difficult cases during an audit.

4. Audit Guidelines:

Discuss this topic based on the empirical foundations of the audit process:

• Preparing the Medical Device Quality audit program.
• Defining the scope and objectives of the audit.
• Various types of audit items.
• Preparing checklists.
• Organizing the kickoff meeting.
• Evaluating and analyzing surgical procedures and risks.

5. Case Studies and Practical Exercises:

• Analyzing Real Scenarios.
• Simulating Audits.
• Discussing Potential Nonconformities.

6. Preparing for the Final Exam

• Comprehensive Review of the Material.
• Sample Questions.
• Exam Passing Strategies.