Internal Auditor ISO13485 MDMS

About ISO 13485:

The ISO 13485 Medical Device Quality Management System Auditor course aims to provide participants with the knowledge and skills necessary to conduct effective internal audits of the medical device quality management system in accordance with the audit guidelines of 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 plan-do-verify-act (PIA) cycle.
• Definition of the scope and importance.
• 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.
• Requirements of regulatory bodies (e.g., FDA, CE, MDSAP).
• Key concepts: risk, traceability, and control of specific processes.
• Identification of risks and opportunities and the actions required to address them..

2. Implementing a Medical Device Quality Management System

• Identifying internal and external stakeholders.
• Roles and responsibilities of senior management.
• 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 Tracking).
• 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, and management review.
• Nonconformities, corrective actions, and continuous improvement..

3. Audit Principles and Guidelines

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

• Audit principles according to the International Standard (19011) Guidelines for Auditing Management Systems.
• The role and responsibilities of the internal auditor according to the standard.
• The competencies and personal characteristics required for the auditor.
• Auditing the IT Service management system
• Assessing and analyzing threats and risks and selecting audit processes.

4. Internal 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.