Lot Inspection Procedure | ISO 13485 | FDA QMSR
Use this editable ISO 13485 Lot Inspection Procedure and related forms to define inspection levels, sample selection, acceptance criteria and recorded decisions for received or produced lots.
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Supplied as one editable Microsoft Word document, with its forms included as attachments, in a digital download.
Lot sampling, acceptance and inspection records
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.
The inspection workflow identifies the applicable lot and acceptance criteria, selects samples randomly, and records the inspection or test results. Reviewers verify signatures and dates and decide whether a lot may be accepted, placed on hold or referred for nonconformance handling. The quality manager approves any release from a hold status. These controls tie the acceptance decision to traceable evidence for the specific lot.
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.
Related acceptance controls
The Receiving and Identification of Materials Procedure covers incoming deliveries before inspection. For material that fails its requirements, see the Nonconforming Material Procedure. The Device History Record Procedure brings acceptance results into the production record for a device lot.
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 Receiving Inspection, First Article Inspection and Lot Acceptance for workflow guidance, a checklist and common mistakes.
