ISO 13485 foundation course

A one-day course on the basic requirements of the ISO 13485:2016 standard for medical devices intended for use in healthcare settings.

This one-day course is designed to enable participants to gain basic knowledge of the requirements of ISO 13485:2016 and how to interpret the requirements, as well as the advantages of implementing a medical device quality management system.

Organizations that need to show evidence that they can provide medical devices which consistently meet customer and regulatory requirements will benefit from understanding ISO 13485.

Recommended follow-up courses: ISO 9001:2015 QMS Foundation and Internal Auditor, Root Cause Analysis and Problem Solving.

Objective

On successful completion of this course, attendees will have:

• Gained detailed knowledge of the clauses of ISO 13485:2016;
• Understand important terms and definitions within the standard;
• The relationship between ISO 13485:2016 and other quality management standards such as ISO 9001:2015;
• Learned the importance of understanding regulatory requirements.

Audience

This course is suitable for anyone involved in auditing, designing, implementing, maintaining and/or improving a medical device quality management system, as well as those wanting to further their knowledge of the ISO 13485 standard.

All our public courses can also be delivered in-house at your premises either as standard or tailored depending on the needs and requirements of your business.

To find out which training courses we offer in your country, click on "Find a local course", select your country and navigate to Medical devices; or Contact us if you are interested or want to know more on in-house courses.