Key Terms

  • Controlled document
    A document the QMS manages formally, versioned, approved, and trained on. (QMS Inputs are not controlled.)

  • Master document
    The parent record for all versions of a document.

  • Document version
    A specific iteration of a document (for example, Quality Management Manual V8).

  • Prefix
    A document's code, in the pattern category number – sequence – type (for example, 21-01-SOP).

  • Effective
    The version currently in force, which users are required to follow.

  • Obsolete
    A version superseded by a newer effective version.

  • Target audience
    The users required to read and be trained on a document.

  • Document status vs. working status
    Document status is set automatically by the release process and cannot be changed manually; working status is a label you set yourself.

  • Role
    A group of users to which permissions and training are assigned.

  • Read & Understood / Questionnaire
    The two methods of completing a training: a confirmation, or a set of questions with a pass mark.

  • Signature PIN
    Your personal code, used as your electronic signature.

Get consultancy for free

Ask anything you need to know about Medical Software, CE certification or MDR.

No obligations, newsletters or follow-up marketing, we promise :)
0/2000

    © 2026 by QMLogic

    Contact Details

    Address:
    QMLogic s.r.o.
    Nove sady 988/2, 602 00 Brno, Czech Republic
    hello@qmlogic.comLinkedin