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 8.7.1: 8.7.1 Actions when nonconformity occurs

On finding a nonconformity, the laboratory shall: act at once to contain and correct it and deal with its consequences, keeping patient safety central and escalating where needed; establish why it happened; decide whether corrective action is needed by reviewing the nonconformity, looking for similar ones that exist or could arise, and judging how likely a recurrence is; carry out the action; check whether the action worked; bring its risks and opportunities up to date; and alter the management system where required.

Maintained by Gerard BlokdykControl text last updated

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