ISO 13485:2016
Measurement, analysis and improvement – ISO 13485:2016

ISO 13485:2016 8.3.3: Actions in response to nonconforming product detected after delivery

When nonconforming product is detected after delivery or after use has started, the organization takes action appropriate to the effects or potential effects of the nonconformity and maintains records of the action. It documents procedures for issuing advisory notices in accordance with applicable regulatory requirements; the procedures can be put into effect at any time, and records of actions relating to advisory notices are maintained.

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