Management Review Under QMSR

Equip your leadership team to meet the new FDA Quality Management System Regulation (QMSR) requirements with confidence.

Equip your leadership team to meet the new FDA Quality Management System Regulation (QMSR) requirements with confidence. This self-paced course walks you through the essential responsibilities of management under ISO 13485:2016, with practical guidance for preparing, conducting, and documenting compliant management reviews. Through four focused lessons, you’ll learn how to align your quality policy, objectives, and review process with FDA expectations — and how to turn management review from a “check-the-box” activity into a strategic driver of compliance and improvement.

At a Glance

Total Length of Course: 1 hour

RAC Points: 1 point

This course was developed by Michelle Lott and Tianna Benson from LeanRA

Learning Objectives

Upon completion of this course, participants should be able to:

Structure management review meetings that satisfy the applicable requirements of QMSR and ISO 13485.

Develop audit-ready records and templates that document leadership engagement and decision-making.

Identify the required inputs and outputs for a management review, determine appropriate attendees, and describe the follow-up process needed to close out action items.

Lesson Titles

Lesson 1: Introduction to Management Responsibility & QMSR

Lesson 2: Setting the Stage for Management Review

Lesson 3: Management Review in Practice: Inputs, Outputs, and Risk Integration

Lesson 4: Leveraging Management Review for Maximum Efficiency