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.

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Supplied as one editable Microsoft Word document, with its forms included as attachments, in a digital download.

QA hold, segregation and release records

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.

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 Medical Device Complaints: Intake, Investigation and Trending for workflow guidance, a checklist and common mistakes.

Part of a procedure bundle

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