SWOT Analysis
- 0137777019
- 02/11/2025
Internal Auditing Skills for ISO 13485:2016 Medical Management System (MMS)
2-3 Days (Customizable based on participant needs)
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.
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.
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.
🔹 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
🔹 Audit Planning & Preparation
🔹 Corrective Actions & Root Cause Analysis
🔹 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.
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
✅ Participants will receive a Certificate of Completion upon successfully completing the course.
✅ Assessment includes a written test, practical audit exercise, and participation evaluation.
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