ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 8: Management system requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 8.4.2: Amendment of records

What does 8.4.2 require?

Changes to records shall be traceable back to earlier versions or the original observations; the laboratory shall keep the original and the changed data and files together with the date of the change (and the time, where relevant), what was changed and who made the change.

Maintained by Gerard BlokdykControl text last updated

Other controls in Clause 8: Management system requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

Query this from an agent

The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.