Internal Audit/ Auditing Skills of ISO13485:2016 Medical Management System (MMS)

Course Title:

Internal Auditing Skills for ISO 13485:2016 Medical Management System (MMS)

Course Duration:

2-3 Days (Customizable based on participant needs)

Course Mode:

• In-person / Online
• Instructor-led training with practical exercises

1. Course Overview

This course is designed to provide participants with the necessary knowledge and skills to perform internal audits of a Medical Management System (MMS) based on ISO 13485:2016. Participants will gain a deep understanding of audit principles, techniques, and reporting in compliance with ISO 19011 guidelines.

2. Course Objectives

By the end of this course, participants will:
✅ Understand the ISO 13485:2016 standard and its relevance to medical device quality management.
✅ Develop practical skills to plan, conduct, and report internal audits in compliance with ISO 19011:2018 guidelines.
✅ Identify nonconformities, risks, and opportunities for improvement in the Medical Management System.
✅ Enhance their auditing skills to ensure compliance with regulatory and quality requirements.
✅ Understand the role of auditors and their responsibilities in ensuring continuous improvement.

3. Learning Outcomes

After completing the training, participants will be able to:
🎯 Explain key requirements of ISO 13485:2016 and how they apply to internal audits.
🎯 Conduct an internal audit using a process-based approach.
🎯 Apply audit techniques such as interviewing, document review, and observation.
🎯 Identify audit findings, nonconformities, and opportunities for improvement.
🎯 Prepare effective audit reports and communicate findings clearly.
🎯 Follow up on corrective actions and verify their effectiveness.

4. Course Outline

Day 1: Understanding ISO 13485:2016 & Internal Audit Fundamentals

🔹 Introduction to ISO 13485:2016
🔹 Overview of Medical Device Quality Management System (MMS)
🔹 Key Requirements of ISO 13485:2016
🔹 Overview of ISO 19011:2018 (Guidelines for Auditing Management Systems)
🔹 Internal Audit Principles & Roles of Auditors

Day 2: Internal Audit Process & Practical Applications

🔹 Audit Planning & Preparation

• Defining audit scope, objectives, and criteria
• Preparing an audit checklist
• Understanding risk-based auditing
  🔹 Conducting an Internal Audit
• Opening meeting
• Audit evidence collection (documents, interviews, observation)
• Identifying nonconformities
  🔹 Audit Findings & Report Writing
• Categorizing nonconformities
• Writing clear and concise audit reports

Day 3: Corrective Actions & Audit Follow-Up (Optional, for extended training)

🔹 Corrective Actions & Root Cause Analysis

• Handling audit nonconformities
• CAPA (Corrective & Preventive Actions) process
  🔹 Audit Follow-Up & Continuous Improvement
• Verifying corrective actions
• Closing an audit
  🔹 Final Assessment & Certification
• Case study & role-play exercises
• Course evaluation & Q&A

5. Training Methodology

🔹 Interactive Presentations – Detailed explanations of ISO 13485:2016 and ISO 19011.
🔹 Case Studies & Group Discussions – Real-world examples of internal audits.
🔹 Role-Playing & Simulation – Practical exercises on conducting audits.
🔹 Workshops & Hands-on Exercises – Audit checklist development, report writing.
🔹 Assessments & Feedback – Quizzes, Q&A sessions, and instructor feedback.

6. Target Audience

This course is ideal for:
✔️ Internal Auditors & Quality Managers
✔️ Compliance & Regulatory Professionals
✔️ Medical Device Manufacturers & Suppliers
✔️ Process Owners & Quality Assurance Teams
✔️ Anyone responsible for ISO 13485:2016 compliance

7. Certification & Assessment

✅ Participants will receive a Certificate of Completion upon successfully completing the course.
✅ Assessment includes a written test, practical audit exercise, and participation evaluation.