Course Description
This course is designed for biomedical engineering students who plan to work in industry with a focus on manufacturing quality systems The course covers industry related to Quality System Management with an emphasis on using an ISO 13485 based QMS. Topics will include: ISO 13485 requirements, including requirements for ISO 13485 documentation (i.e. quality objectives, quality manual, procedures, work instructions, quality system records, etc). Other topics will include planning, conducting, and documenting an internal audit. At the end of the course the students may earn a NCSU-IES certification as an ISO 13485 internal auditor.
Spring 2026
Instructors
Meeting Patterns
Classes Start:
January 12, 2026
Classes End:
April 28, 2026
Location:
02015 Engineering Building I
Class Days:
M
Class Start Time:
4:30pm
Class End Time:
7:15pm
Class Type:
Lecture
Credits:
3.00
Restrictions:
R: Graduate Standing