ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence
Clause 7: Process requirements – ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence

ISO 15189:2022 - Medical Laboratories Requirements for Quality and Competence 7.4.1.8: Amendments to reported results

What does 7.4.1.8 require?

Procedures for results that are amended or revised shall make sure that: why the result changed is recorded and, where relevant, stated on the revised report; a revised result is issued only as a separate document or data transfer plainly marked as revised, showing the original date and the patient's identity; the user is told; a wholly new report carries its own identity and can be traced to the one it supersedes; and, if the reporting system cannot hold revisions, a separate record is kept.

Maintained by Gerard BlokdykControl text last updated

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