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

ISO 13485:2016 8.3.2: Actions in response to nonconforming product detected before delivery

The organization deals with nonconforming product by eliminating the detected nonconformity, precluding its original intended use or application, or authorizing its use, release or acceptance under concession. Nonconforming product is accepted by concession only where justification is provided, approval obtained and applicable regulatory requirements met, and records of the concession and the identity of the person authorizing it are maintained.

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