All pathsQA · Operations · 10 terms

QMS Foundations

Name: QMS Foundations
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Quality system terminology grounded in QSR, the upcoming QMSR, and ISO 13485.

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1

Quality & Risk

Quality System Regulation(QSR / 21 CFR 820)

FDA's current good manufacturing practice (cGMP) requirements for medical devices.

Why this term here: The current US quality-system rule (21 CFR 820). Focus on the sections that map cleanly to ISO 13485 and the ones that do not.
2

Quality & Risk

Quality Management System Regulation(QMSR)

FDA's harmonized successor to the QSR, incorporating ISO 13485:2016 by reference.

Why this term here: The QSR replacement that harmonizes with ISO 13485. Focus on the effective date and the delta versus today's QSR.
3

Standards

ISO 13485

International standard for medical device quality management systems.

Why this term here: The global QMS standard. Focus on clauses 4-8 and how they underpin both QMSR and MDR/IVDR expectations.
4

Quality & Risk

Design Controls

Structured process governing the design of medical devices.

Why this term here: The heart of your QMS from a submission perspective. Focus on planning, inputs, outputs, and traceability.
5

Quality & Risk

Verification & Validation(V&V)

Confirming design outputs meet inputs (V) and that devices meet user needs (V).

Why this term here: Where design controls meet evidence. Focus on the difference and on when validation must involve real users.
6

Quality & Risk

Design History File(DHF)

Compilation of records describing the design history of a finished device.

Why this term here: The proof that design controls happened. Focus on what belongs in the DHF versus the technical file.
7

Quality & Risk

Corrective and Preventive Action(CAPA)

Systematic process to investigate and resolve quality issues and prevent recurrence.

Why this term here: The most-cited system in FDA inspections. Focus on root-cause rigor and effectiveness checks, not just closure.
8

Quality & Risk

Complaint Handling

Process for receiving, evaluating, and responding to device complaints.

Why this term here: The main input to CAPA. Focus on complaint definition, MDR decision logic, and trending.
9

Quality & Risk

FDA Form 483

Notice of inspectional observations issued at the conclusion of an FDA inspection.

Why this term here: The inspector's observation form. Focus on how to write a response that actually closes findings.
10

Quality & Risk

Warning Letter

Formal FDA notification of significant violations requiring prompt corrective action.

Why this term here: What escalated 483s become. Focus on reading warning letters as free training data for your own audits.

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QMS Foundations

Quality System Regulation(QSR / 21 CFR 820)

Quality Management System Regulation(QMSR)

ISO 13485

Design Controls

Verification & Validation(V&V)

Design History File(DHF)

Corrective and Preventive Action(CAPA)

Complaint Handling

FDA Form 483

Warning Letter