Product Hold Procedure | ISO 13485 | FDA QMSR

Control suspected or confirmed nonconforming medical devices with this editable Product Hold Procedure and related forms. It defines when to assign QA Hold status, how to identify and segregate affected product, who communicates with facilities or customers, and how an authorized QA Release is documented.

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.

• Quality assurance hold and release decisions

• Notification, segregation and facility responsibilities

• Hold numbering, tracking and release communication

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.

If a hold follows a customer report, use the Complaint Handling Procedure to manage the complaint record. If broader field action is needed, see the Remedial Action and Recall Procedure. All three are included in the Complaint Handling Procedures Bundle.

Supplied as editable Microsoft Word documents with related forms in a digital download.

Part of a procedure bundle

This document is also included in Complaint Handling Procedures Bundle. Explore the bundle for the related documents.