Product Hold Procedure | ISO 13485 | FDA QSR Compliant
- ISO 13485 and FDA QSR Compliant
- Includes Related Forms
- MS Word Format
- Digital Content - Instant Download
Product Hold ProcedureThe 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 - OverviewThe 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. Product Hold Procedure - ComplianceThe Product Hold Procedure is 21 CFR Part 820 and ISO 13485:2016 compliant.
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