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Course Detail: WTMD940 - Introduction to Quality Systems
This 21-hour course introduces participants to the quality systems that govern the life science industry with emphasis on the system that impacts specifically medical device development and manufacturing. In 2026, the FDA adopted the globally recognized standard, ISO 13485:2016, as the new Quality Management System Regulation (QMSR). Mastery of these core skills is key to successful careers in the medical device and bioscience industry.
Upon successful completion of this course, students will be able to:
1. Explain the impact of ISO 13485:2016 Quality Management System Regulation (QMSR) on a non-compliant medical device company and potential consequences for non-compliance.
2. Understand the overall structure and objectives of the Quality Management System Regulation (QMSR). ISO 13485:2016, Section 4.0
3. Identify the key components of Management Responsibility, ISO 13485:2016, Section 5.0.
4. Explain the purpose of ISO 13485:2016, Section 6.0 Resource Management.
5. Explain the purpose of ISO 13485:2016, Section 7.0 Product Realization.
6. Explain the purpose of ISO 13485:2016, Section 7.5 Production and Service Provision
7. Explain the purpose of ISO 13485:2016, Section 8.0 Measurement, Analysis, and Improvement.
8. Understand the basic requirements and benefits for conducting internal audits under ISO 13485:2016
This course is one of four in the Medical Device Manufacturing Processes and Practices Microcredential program. Upon successful completion of the four-course microcredential, students will qualify for entry-level positions, including Quality Technician, Quality Inspector, and Quality Assurance Inspector.?
STIT Funding available if you are a Utah resident. Please click here to apply!