21 CFR Part 820 / QMSR · Subpart A

General Provisions and QMSR Scope

What the Quality Management System Regulation binds, how it now incorporates ISO 13485 by reference, and the definitions the rest of the system is written in. Also the point at which a firm decides which requirements it may exclude, and on what basis.

What you will be able to do

State which devices and operations the regulation applies to
Explain how the QMSR relates to ISO 13485 and what changed on incorporation
Justify an exclusion in a way that would survive inspection

What the package includes

Full-length training video, presenter-led
Presenter script
Companion handout for the subpart
Ten-question graded assessment
Audit-ready SOPs for the subpart
Fillable records and supporting documents

Listed runtime 28 minutes. Which materials open on your account depends on the plan you hold.

Watch this module on the free trial

The three-day trial opens the first six modules of 21 CFR Part 820 / QMSR on screen. No card, and nothing converts automatically.Start the 3-day trial See pricing