ISO 13485 Procedure 830-Control of Nonconforming Product

Describes the process used to ensure product that does not conform to product requirements is identified and controlled to prevent unintended use or delivery.

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Language: English
Product Type: Procedures
Provider: 13485 Store

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  • Describes how a nonconforming material, part or product is identified, and actions to be taken to eliminate the detected nonconformity, authorize its use under concession, or preclude its original intended use or application.
  • The procedure assigns responsibilities for labeling the nonconforming material, disposing and documenting the disposition of the material, and/or contacting customers for concession if nonconforming product is to be used.


  • Customizable ISO 13485 Control of Nonconforming Product Procedure
  • Rejected Material/Disposition Report - NCR Form
  • Supplier Corrective Action Request Form
  • Corrective Action Request Form

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