QS Regulation 2: Quality System Requirements
<p>The second in a series of Quality System (QS) Regulation courses, this course focuses on the management responsibility, quality auditing, and personnel requirements of 21 CFR Part 820, Subpart B. The QS Regulation provides a framework of basic requirements for manufacturers of finished medical devices. Topics in this course include: Terms, Requirements, Structure, Management Representative, Management Reviews, Plan and Procedures, Audits, Personnel, and Preamble. After completing this course, learners will be able to recognize the QS Regulation requirements associated with a firm’s management responsibility, quality auditing, and personnel.</p><p>Learners should complete QS Regulation 1: Overview and General Provisions before taking this course.</p>
After this course learners will be able to recognize the qs regulation requirements associated with a firm's management responsibility, quality auditing, and personnel.