Product Hold Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Product Hold Procedure controls product that has or will be distributed to customers globally by assigning a Hold or Release status to products either suspected or confirmed to be nonconforming.

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Product Hold Procedure

The Product Hold Procedure controls product that has or will be distributed to customers globally by assigning a Hold or Release status to products either suspected or confirmed to be nonconforming.

Product Hold Procedure - Overview

The Product Hold Procedure defines the responsibilities, process and required customer notification to isolate nonconforming product within a facility and after a product has been shipped to customers / distributors. The Product Hold Procedure defines the process and methods of communication to place suspect product on "QA Hold" and the process to release segregated product through a "QA Release" process. The Product Hold Procedure includes all related forms.

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.