The Quality Management System (QMS) is the operational backbone of every medical-device manufacturer. The FDA, through 21 CFR Part 820, and ISO 13485:2016 establish the essential requirements for designing, manufacturing, distributing, and surveilling health products safely and effectively. With the FDA Quality Management System Regulation (QMSR) Final Rule, published in January 2024 and effective February 2, 2026, the U.S. and international frameworks formally harmonize — and for quality professionals this means a new operational layer that must be commanded immediately.

This 16-hour Professional Certificate Course is the entry point of the Aleph Quality Management Systems for Medical Devices course track. It introduces ISO 13485:2016 at a structural level (clauses 4–8), the structure of 21 CFR Part 820 with the QMSR Final Rule overlay, and the four FDA QMS subsystems (Production and Process Controls, Design Controls, Management, CAPA) that FDA inspectors use to organize a routine inspection. The course also orients participants to Good Documentation Practices, the process approach and PDCA cycle, and the surrounding pieces — Design Controls, CAPA, and Management Review — that the Advanced level extends into hands-on document authoring.

The course prepares participants for the Advanced level (`RAQ-520-A`), where the same content is exercised at applied depth — authoring Manufacturing Quality Control Plans, Inspection Test Plans, Material Review Board procedures, Design & Development Plans, Process FMEAs, Customer Complaint records, supplier audit plans, and a full Management Review structure. Together the Introductory and Advanced levels form a 48-hour course track.

The Introductory course establishes the QMS vocabulary the medical-device industry expects of someone entering a quality, regulatory, audit, or operations role. Employers in this space include medical-device manufacturers, contract manufacturing organizations, and consultancies serving manufacturers preparing for FDA inspection or ISO 13485 certification.

Participants who meet the course completion requirements receive a Certificate of Completion issued by Aleph University.