Lot Inspection Procedure | ISO 13485 | FDA QMSR

The ISO 13485:2016 Lot Inspection Procedure governs lot inspection and the systematic review of inspection levels applied to lot inspection.

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ISO 13485:2016 Lot Inspection Procedure Overview

The Lot Inspection Procedure applies to all products, components and material received or produced by the company. The Lot Inspection Procedure includes a quality record form document and a lot inspection data form document.

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.