Nonconforming Material Procedure | ISO 13485 | FDA QMSR

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The ISO 13485:2016 Nonconforming Material Procedure establishes a process to control and disposition nonconforming material identified during receiving, in-process, or final product acceptance activity.

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Nonconforming Material Procedure

The Nonconforming Material Procedure establishes the process used to control and disposition nonconforming materials. The nonconforming material procedure applies to all nonconforming material or products identified during receiving, in-process, or final product acceptance activity.

Nonconforming Material Procedure - Overview

The Nonconforming Material Procedure governs failure of a raw material, component, sub-assembly, or finished product to meet an applicable specification. The Nonconforming Material Procedure provides instruction on identification of nonconforming material, segregation of discrepant product, and the methods of disposition of rejected product by qualified staff. The Nonconforming Material Procedure also includes a NCMR Report Form.

Regulatory framework

For U.S. medical devices, the applicable quality-system framework is FDA's Quality Management System Regulation (QMSR), 21 CFR Part 820, effective February 2, 2026. It incorporates ISO 13485:2016 and includes additional FDA requirements. Adapt and implement this documentation for your device, activities and markets; purchasing a document does not establish regulatory compliance or certification.