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

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Description

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.

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