Course Length:
8 hours -4 sessions, 2 hours each

Format:
Instructor Led On-Line Course

Course Objective

1. Understand ISO 13485:2016 Standards
Gain a thorough understanding of the ISO 13485:2016 requirements and
how they apply to quality management systems in the medical device
industry.

2. Develop Internal Auditing Skills
Learn how to plan, conduct, report, and follow up on internal audits in
accordance with ISO 13485:2016.
3. Interpret and Manage Audit Findings
Develop skills to interpret audit findings, assess non-conformities, and
implement effective corrective actions.
4. Enhance Reporting and Communication
Improve documentation and communication skills to effectively convey
audit results and drive improvements
5. Ensure Compliance and Support Continuous Improvement
Understand how internal audits contribute to compliance with ISO
13485:2016 and facilitate continual improvement of the quality
management system.

Course Content:

1: Introduction to ISO 13485:2016
• Overview of ISO 13485:2016
History and evolution of ISO 13485
Key principles and structure of the standard
Differences between ISO 13485:2016 and ISO 9001:2016
• Context of the Organization
Understanding the regulatory and quality management requirements
specific to medical devices
Scope and applicability of the QMS in the medical device industry

2: Fundamentals of Internal Auditing
• Principles and Objectives
Objectives and benefits of internal audits in the context of medical devices
Key principles of internal auditing
Types of audits and their purposes
• Internal Audit Process
Planning the audit
Conducting the audit
Reporting audit findings
Follow-up and corrective actions

3: Planning the Audit
• Audit Planning and Preparation
Defining the audit scope and objectives specific to ISO 13485:2016
Developing an audit plan and schedule
Selecting and training audit team members

Criteria and Documentation
Preparing audit criteria, checklists, and tools tailored for ISO 13485:2016

4: Conducting the Audit
• Audit Techniques and Methods
Effective interviewing techniques for medical device processes
Observations and document reviews
Sampling strategies and evidence collection
• Managing Evidence
Ensuring accuracy and reliability of audit evidence
Documenting findings and observations

5: Reporting Audit Findings
• Effective Reporting Techniques
Structuring audit reports in line with ISO 13485:2016 requirements
Communicating findings, recommendations, and areas for improvement
Writing non-conformance reports and action plans
• Management Review
Presenting findings to management
Developing and tracking action plans for non-conformities

6: Follow-Up and Continuous Improvement
• Addressing Non-Conformities
Conducting root cause analysis and implementing corrective actions
Verification of corrective actions and effectiveness
• Promoting Improvement
Utilizing audit results for continual improvement

Best practices for maintaining and enhancing the QMS

7: Case Studies and Practical Exercises
• Industry-Specific Case Studies
Analysis of case studies relevant to ISO 13485:2016 audits in the medical
device industry
Practical exercises and role-plays simulating audit scenarios
• Audit Simulation
Conducting a mock audit based on ISO 13485:2016
Reviewing and discussing audit outcomes and findings

8: Exam and Certification
• Final Assessment
o Knowledge check through a written exam or practical assessment
• Certification
o Issuance of certificates upon successful completion of the course