Nonconforming Material Procedure | ISO 13485 | FDA QSR Compliant
SKU: SOP 8-008
The ISO 13485 Nonconforming Material Procedure establishes a process to control and disposition nonconforming material identified during receiving, in-process, or final product acceptance activity.
- ISO 13485:2016 Compliant
- FDA QSR Compliant
- Includes Related Forms
- MS Word Format
- Digital Content - Instant Download
Nonconforming Material Procedure
The ISO 13485 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.
ISO 13485 Nonconforming Material Procedure Overview
Non-Conformance: A failure of a raw material, component, sub-assembly, or finished product to meet an applicable specification or procedure, is identified as a reject, and is segregated from conforming product.
Material Review Board (MRB): A team representing multiple areas of technical expertise assigned to the duties of dispositioning all non-conforming products.
Rework: is a reprocessing or modification of product in order to bring the product into conformance to a specification. A written instruction describing the rework process and including inspection, for each reworked item prior to conducting such rework.
USE AS IS (UAI): A determination is made that the non-conformance does not affect the functionality of the product and can be Used-As-Is. A written rationale must be generated to support this conclusion and included in, or attached to the NCMR report.
The ISO 13485 Nonconforming Material Procedure includes a detailed NCMR Report Form.
ISO 13485 Nonconforming Material Procedure Compliance
The ISO 13485 Nonconforming Material Procedure is FDA QSR and ISO 13485:2016 compliant
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