Facility Inspection Procedure

Use this editable Facility Inspection Procedure to prepare for and manage external inspections of a medical device facility by FDA, notified bodies, government agencies and other third parties.

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Supplied as one editable Microsoft Word document in a digital download.

The procedure assigns an inspection coordinator and alternates, identifies who should be notified when an inspector arrives, and sets responsibilities for accompanying inspectors, handling document requests and recording questions or observations. It also addresses inspection restrictions, the exit interview and timelines for post-inspection activities.

These steps help your team respond consistently and preserve a record of requests, materials provided, observations and follow-up actions.

External inspection readiness and response

Choose this procedure when your team needs an organized approach to an external inspection: identify the coordinator and alternates, notify the responsible personnel, manage accompanying staff and document requests, record observations, and coordinate the exit interview and follow-up. Review and assign these responsibilities before an inspection occurs.

Facility inspection or internal audit?

An external inspection is conducted by an authority or other outside organization. An internal audit is a planned assessment performed within your quality system. This product addresses managing the external inspection visit; the separately sold Internal Audit Procedure addresses your internal audit process.

For current U.S. inspection context, consult FDA's medical device compliance programs. FDA replaced QSIT with the inspection process in Compliance Program 7382.850 on February 2, 2026. Use the current agency materials when preparing your team.

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 Internal Audits vs External Medical Device Facility Inspections for workflow guidance, a checklist and common mistakes.

Related procedures

For planned assessments within your quality system, see the Internal Audit Procedure. To document and follow through on actions arising from inspection findings, see the Corrective and Preventive Action (CAPA) Procedure.