COURSE DESCRIPTION: GAP ANALYSIS BETWEEN ISO 9001 AND ISO 13485

This one-day course is designed for professionals who are already familiar with ISO 9001 and want to understand the additional requirements needed to comply with ISO 13485 for medical devices. Through a structured comparison of the two standards, participants will gain practical insight into the key gaps and areas requiring attention when transitioning from ISO 9001 to ISO 13485.

The course covers differences in documentation requirements, management responsibility, resource management, product realization, supplier management, design and development, production and service provision, post-market surveillance, and CAPA processes. Participants will leave with a clear understanding of where ISO 13485 extends beyond ISO 9001 and how these requirements can be implemented within an existing Quality Management System.                                                                                                                                                                                                                     

WHO SHOULD ATTEND?

This course is intended for professionals with prior knowledge of ISO 9001, including:

• Quality Managers and Quality Engineers
• Regulatory Affairs professionals
• Management Representatives and QMS owners
• Internal Auditors / Supplier Audits
• Project Managers involved in quality system implementation
• Professionals supporting organizations transitioning from ISO 9001 to ISO 13485

LEARNING OBJECTIVES

After completing the course, participants will be able to:

• Understand the key differences between ISO 9001 and ISO 13485
• Identify gaps in an existing ISO 9001 Quality Management System
• Recognize medical device-specific quality and regulatory requirements
• Establish a roadmap for achieving ISO 13485 compliance
• Prepare their organization for implementation and certification activities

TRAINERS

Bolette Nordby, Sr. Consultant and Owner, NOEI Medical Device
Liselotte Blond Sørensen, Sr. Consultant and Partner, Danish Medical Devices Consulting ApS