Overview

ISO 13485 is the internationally recognized standard for quality management in the medical device industry. Developed by the International Organization for Standardization (ISO), this standard ensures that medical devices are safe, effective, and meet the needs of patients and end-users.

Compliance with ISO 13485 not only demonstrates your organization’s commitment to quality and safety but also helps you:

• Identify and mitigate risks effectively.
• Enhance operational efficiency and processes.
• Improve product quality and customer satisfaction.

But how confident are you in your understanding of this critical standard? Can you effectively apply it to your organization’s Quality Management System (QMS)?

This ISO 13485 Internal Auditor training course equips you with the knowledge and skills to perform internal audits with confidence. You’ll learn industry-proven techniques and gain practical insights into applying the ISO 13485:2016 standard to real-world audit scenarios. The course covers the full audit process, including tools and preparation, opening meetings, interviews, closing meetings, and reporting, ensuring you have a comprehensive understanding of quality system auditing.

Whether you’re new to the quality field, expanding your expertise, or a seasoned professional, this course is designed to meet your needs. It provides foundational knowledge for beginners, advanced insights for experienced practitioners, and the latest best practices for industry veterans.

In this interactive, live-online course, our expert instructors emphasize practical application, using hands-on activities and case studies to reinforce your understanding of ISO 13485 requirements. You’ll leave the course with the skills and confidence to drive quality and compliance within your organization.

Pre-Requisites

There are no required prerequisites for this training.

This ISO 13485 Internal Auditor training course is beneficial for both quality novices and lifetime professionals.

All attendees are required to bring their own copy of the ISO 13485:2016 Quality Management Standard Requirements to this training course.

These will not be provided for you.

We strongly advise you bring a paper copy or an electronic copy that allows you to take notes.

Who Should Attend

• Quality directors
• Managers
• Engineers
• Auditors
• ISO coordinators
• Laboratory quality professionals
• Anyone engaged in quality audits or quality assurance for medical devices

1. Course requirements
2. How to get the most out of this experience
3. Networking with industry professionals
4. Self-assessment of audit skills and international standards

1. Quality industry vernacular from ISO 9001, ISO 13485
2. Differentiating between verification and validation
3. Understanding corrective and preventive actions
4. Medical device unique terms: clinical evaluation, advisory notice, complaint
5. Activity #1: Terminology

1. Demystifying the ISO 13485 standard
2. Interpreting and cross-referencing the quality standard
3. Analyzing audit findings
4. Audit exercises for application of ISO 13485 to quality events
5. Quizzes for the ISO 13485 Standard
6. Activity #2: Case studies #1-#12

1. Roles of Auditors, Auditees, and Management during Internal Audits (IAs)
2. Qualifying Auditors
3. Duties of the IA staff
4. Role Play Audit #1: Prepare to perform an Internal Audit

1. Audit Tools – checklists, process maps, findings, reports
2. Conducting Audit Interviews
3. Role Play Audit #1: Mock Audits with Classmates

1. Audit Interviewing techniques
2. Continual improvement techniques
3. Developing a “continual improvement” attitude in the organization
4. Activity #4: Writing Audit Findings

1. Writing the audit report
2. Opening and Closing Meetings

1. Comparing FDA 21 CFR 820 paragraphs to the requirements of ISO 13485
2. Evaluating the FDA requirements where significantly different from ISO 13485
3. Activity #3: FDA Audit Cases #1-#15