Change History
==============

.. important::
   **Recording of change history is a requirement under ISO 15189:2022 (Management System Requirements, Document Control).** This section should therefore be included in an SOP if the laboratory/organisation does not make use of an electronic Quality Management System (eQMS) that records changes to controlled documents.

The 'Change History' section of an SOP consists of a list of entries detailing the changes made since the publication of version 1 of a controlled document. Each entry should record:

- Whether the change was *minor* or *major*:
   - **Minor change:** Any minimal update that does not alter the meaning or intent of the SOP 
     (e.g. typographical corrections, formatting adjustments, clarifications of wording).
   - **Major change:** Any substantive update that affects the procedure, responsibilities, or scope of the SOP.
- The **date of the change**.
- The **version implemented**.
- The **authorising person/role**.

.. note::
  Consider implementing a **threshold rule** for classifying changes. For example, if 10 minor change requests have been accumulated since the last major version, the next update must be classified as a *major change* and a new version number assigned.

-------

.. dropdown:: Example

  .. list-table::
   :header-rows: 1
   :widths: 15 60 20 15

   * - Date
     - Description of change
     - Version implemented
     - Authorised by
   * - 08/09/2022
     - Major restructure to procedure section to make code review process clearer.
     - V2.0
     - J. Patel
   * - 15/01/2023
     - GitLab templates added to appendix
     - V1.1
     - S. Thompson
   * - 14/01/2023
     - Original document
     - V1.0
     - S. Thompson

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