Call ASQ Biomedical Task Group for the next scheduled training course
Contact: Ralph Arnott 651-633-0265

This workshop is designed to provide a detailed overview of the FDA’s QSR with comparisons to ISO 9001 and ISO 13485. Students will receive a basic understanding of the Quality System Requirements (QSR) from a business operations model perspective. There will also be a practice drill delving into the details for auditor application. The discussion will include the mapping back to the ISO 9001 and ISO 13485 standard requirements, with the intent of merging these management systems into a beneficial program for the organization. Case studies will be used to help the students apply the knowledge to “real world situations”.

Course Agenda
Introduction/Course Agenda and Objectives – Terms and Definitions -Purpose of QMS – QSR 820 Sections/Associated ISO Clauses – Case Studies #1 – QSR 820 Sections/Associated ISO Clauses – Case Studies #2 – Documentation is a QSR System – Conclusion

Each class is set up for up to twenty (20) students. Included with the class is the course book, materials, copy of the QSR, and a certificate of completion.