QMSR Section 820.10 (Quality Management System)

The core requirement of Part 820. A manufacturer must document a quality management system that meets the applicable requirements of ISO 13485 and the other applicable requirements of the part. It also ties named ISO clauses to other regulations in Title 21.

What each paragraph requires

820.10(a)

Document a quality management system that meets the applicable requirements of ISO 13485 and the other applicable requirements of Part 820.

820.10(b)

Meet other regulations in Title 21 where the named ISO clause points to them: UDI under Part 830 (clause 7.5.8), traceability under Part 821 (clause 7.5.9.1), complaint reporting to the FDA under Part 803 (clause 8.2.3), and advisory notices under Part 806 (clauses 7.2.3, 8.2.3, and 8.3.3).

820.10(c)

Meet the design and development requirements of clause 7.3 for Class II devices, Class III devices, and the Class I devices listed: those automated with computer software and the five in the table.

820.10(d)

For devices that support or sustain life, meet the traceability requirements for implantable devices in clause 7.5.9.2.

820.10(e)

Failing to meet any applicable requirement renders a device adulterated under section 501(h) of the Federal Food, Drug, and Cosmetic Act.

Where it is written

21 CFR 820.10

Also called

21 CFR 820.10, 820.10

Related terms