All terms
Nonconformance (NCR)
Failure of a product, process, or system to meet specified requirements.
Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026
Definition
A nonconformance is documented evidence that a product, process, or system did not conform to specified requirements. Investigation may lead to disposition (use as is, rework, scrap) and/or a CAPA. What the regulation says
Regulators view nonconformances as critical indicators of quality system effectiveness and product safety. For example, FDA 21 CFR Part 820.90 requires manufacturers to establish procedures for controlling nonconforming product, including identification, documentation, evaluation, segregation, and disposition. Similarly, EU MDR (Regulation (EU) 2017/745) Annex I, General Safety and Performance Requirements, implicitly demands robust handling of nonconformities to ensure devices meet safety and performance objectives throughout their lifecycle. ISO 13485:2016, clause 8.3, specifically details requirements for the control of nonconforming product, emphasizing documentation and appropriate action commensurate with the nonconformity.What this means in practice
Trend analysis of NCRs is a key feedback loop into design and process improvements.Examples
- During final inspection, a batch of sterilization pouches is found to have seals outside the specified width, leading to the generation of a nonconformance report.
- A software validation test fails to produce the expected output for a critical function, initiating a nonconformance process to investigate the code defect.
- Customer feedback indicates that a specific MedTech device is intermittently freezing, prompting a nonconformance investigation into potential underlying hardware or software issues.
Common pitfalls
- •Confusing a nonconformance with a deviation; a nonconformance indicates failure to meet a requirement, while a deviation is a departure from an approved procedure without necessarily failing a requirement.
- •Failing to adequately investigate the root cause of nonconformances, which can lead to recurrence and persistent quality issues.
- •Treating all nonconformances with the same level of urgency rather than prioritizing based on risk to patient safety or product quality.
- •Not integrating nonconformance data into broader quality system processes like management review, risk management, and CAPA.
- •Failing to ensure that disposition actions for nonconforming product are properly implemented and verified.
Frequently asked questions
Documenting a nonconformance ensures that deviations from specified requirements are formally recorded, investigated, and addressed, providing a clear audit trail for quality assurance and regulatory compliance.
Cross-references
Related terms
Shared paths + categoryQuality & Risk
Corrective and Preventive Action(CAPA)
Systematic process to investigate and resolve quality issues and prevent recurrence.
Same category
Quality & Risk
Biocompatibility
Ability of a material to perform with an appropriate host response in a specific application.
Manufacturing & Supply Chain
Quality & Risk
Change Control
Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance.
Manufacturing & Supply Chain
Manufacturing
Design Transfer
Translating design into production specifications.
Manufacturing & Supply Chain · adjacent
Quality & Risk
IQ / OQ / PQ
Installation, Operational, and Performance Qualification - the three stages of equipment and process qualification.
Manufacturing & Supply Chain
Manufacturing
Lot Traceability
Ability to trace materials, processes, and devices forward and backward through the supply chain by lot number.
Manufacturing & Supply Chain · adjacent
Latest in MedTech
Primary references
3 sourcesLink health: 3 verified· last checked 2026-06-20
eCFR·1FDA·1ISO·1
- 121 CFR 820.90VerifiedeCFRecfr.gov
- 2FDA - Quality SystemsVerifiedFDAfda.gov
- 3ISO 13485 Standard PageVerifiedISOiso.org
Inline markers like [1] jump to the matching reference above.