Medical Devices : ISO 13485 Internal Auditor

Enhance your expertise in quality management with our “ISO 13485:2016 Internal Auditor” course. This program is meticulously crafted for professionals in the medical device industry—specifically Quality Assurance Managers, Regulatory Affairs Specialists, and Quality Systems Engineers—who are looking to strengthen their auditing acumen.

📚 Course Highlights:

• In-depth understanding of both ISO 13485:2016 and ISO 19011:2018 standards.
• Interactive exercises in audit planning, execution, and reporting.
• Strategies for impactful corrective actions and consistent audit follow-up.

Guided by industry experts, this online training course provides a practical and comprehensive dive into the audit cycle of medical devices, equipping you with the skills needed for exceptional internal audit performance.

🚀 Certification:

Complete the course to receive a traceable, uniquely numbered certificate of completion, providing evidence of your updated qualifications. The certificate, bearing the date of issue, can be downloaded as a PDF and is print-ready for inclusion in your professional records.

Step into a leadership role in quality assurance within the medical device field. Begin your journey today and establish yourself as a pivotal part of your organization’s commitment to excellence in internal auditing.

Curriculum:

Introduction

Overview of ISO 13485 : 2016 Standard Internal

Lesson 1: Quality Management System

Lesson 2: Management Responsibility

Lesson 3: Resource Management

Lesson 4: Product Realization

Lesson 5: Measurement, Analysis, and Improvement

Glossary

Evaluation