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    All pathsQA · Operations · 10 terms

    QMS Foundations

    Quality system terminology grounded in QSR, the upcoming QMSR, and ISO 13485.

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    1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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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