Gap 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.
Course desciption
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
Senior Consultant and Owner, NOEI Medical Device Consulting
Bolette Nordby specialises in developing practical, scalable and risk-based quality management systems for medical devices. On this course, she helps participants identify where ISO 13485 introduces additional medical device-specific requirements beyond ISO 9001 and translate the identified gaps into concrete changes to processes, responsibilities and documentation.
Liselotte Blond Sørensen
Senior Consultant and Partner, Danish Medical Devices Consulting ApS
Liselotte Blond Sørensen has extensive experience in medical device quality assurance and regulatory affairs and is a lead auditor for both ISO 9001 and ISO 13485. On this course, she guides participants through a structured comparison of the two standards, focusing on areas such as documentation, design and development, supplier management, production, post-market surveillance and CAPA.
Contact
Select date
4 February 20274 February 2027 - at 09:00 - 16:30
Price ex. VATLatest Registration
1 February 2027
Latest Cancellation
14 January 2027
Bøge Allé 5, 2. th
2970 Hørsholm
View Program
Terms
In-house Courses
MedTech Academy offers in-house training courses tailored to your specific needs. Courses can be based on our open programme or developed specifically for your organisation. You choose the focus, format and timing – and work with your own cases in a confidential setting. Contact us to discuss the possibilities.
Do You Have a Specific Competency Need?
We continuously develop and update MedTech Academy’s course portfolio to match the current needs of medical device companies. If you are looking for a specific course, or if you are unsure which course is the right fit for you and your organisation, you are always welcome to contact us.
Berit Munkebo
Head of Development
bm@medicoindustrien.dk
Academy News
Academy News is Medicoindustrien’s weekly newsletter with a complete overview of upcoming and newly developed courses from MedTech Academy. The newsletter provides a quick overview of new dates, upcoming sessions and current course topics for professionals working with medical devices.