GLOSSARYGlobal
Nonconforming Product
A product that does not meet a specified requirement. ISO 13485 clause 8.3 requires the manufacturer to identify it and control it so that it is not used or delivered unintentionally.
Avoid This Mistake
Accepting nonconforming product by concession is allowed only when justified, approved, and compliant with applicable regulatory requirements. The FDA expects scientific evidence behind the justification.