Nonconformity

A requirement that has not been met, whether the requirement is stated, generally implied, or obligatory.

Where it is written: ISO 9000:2015 clause 3.6.9, applied through 21 CFR 820.3 and ISO 13485:2016 clause 3
Also called: non-conformity

Avoid This Mistake

Nonconformity is not limited to defective product. The definition covers any unmet requirement.

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