Maps to
FDA QMSR (Part 820): §820.90
ISO 13485: ISO 13485 §8.3
Requirement text
Nonconforming product shall be identified and controlled to prevent unintended use or delivery.
Atomic constraints
- •Nonconforming product must be identified and segregated
- •Disposition decisions must be documented
- •Rework must follow documented procedures
- •Concessions must be justified and approved
Evidence signals
- •
FILE_EXISTS
(NCR|Nonconform|Non.conform|Disposition|Rework|NCMR)
- •
CONTENT_MATCH
Does this document describe procedures for identifying, segregating, or dispositioning nonconforming product?
Audit defense
Nonconforming product control for [your product] is managed through [your document ID]. All nonconforming product is identified, segregated, and dispositioned through our formal NCR process. Rework follows documented procedures with re-inspection before release per QMSR 820.90.