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.

Example

Date

Description of change

Version implemented

Authorised by

08/09/2022

Major restructure to procedure section to make code review process clearer.

V2.0

  1. Patel

15/01/2023

GitLab templates added to appendix

V1.1

  1. Thompson

14/01/2023

Original document

V1.0

  1. Thompson