Nonconforming Material Procedure | ISO 13485 | FDA QMSR
Identify, segregate and disposition nonconforming materials and medical device products with this editable ISO 13485 Nonconforming Material Procedure and NCMR form. It covers receiving, in-process and final acceptance discrepancies, review-board decisions, rework or return, approvals and closure.
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Supplied as two editable Microsoft Word documents (the procedure and one form) in a digital download.
Material segregation, disposition and NCMR records
It addresses raw materials, components, subassemblies and finished products that fail an applicable specification. The document covers identification, segregation and disposition of rejected product by qualified staff, and includes an NCMR report form.
An originator opens a nonconforming-material report and identifies affected material for segregation. The review board assesses the discrepancy, decides whether to reject, return, rework or otherwise disposition the item, and records the rationale and approvals. Supplier returns and any additional inspections are documented before release or closure. The process gives production and quality a common record for material that does not meet its specification.
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.
When a recurring or significant nonconformance needs investigation and action, continue with the CAPA Procedure.
Using an eQMS? These editable Microsoft Office files can be imported into any electronic quality management system (eQMS) that manages Word and Excel documents, or used in a paper-based system. Adapt the approval, signature and record steps to your system’s workflow, and validate the eQMS software under your own QMS. See how to use A.P. Lyon procedures in an eQMS.
Practical guide
Read Nonconforming Material, Failure Investigation and CAPA for workflow guidance, a checklist and common mistakes.
