Facility Inspection Procedure

The ISO 13485:2016 Facility Inspection Procedure defines the process and responsibilities for handling facility inspections conducted by FDA, Notified Bodies, Government Agencies and other third-party inspections.

• MS Word Format

• Digital Content - Instant Download

Facility Inspection Procedure

The Facility Inspection Procedure defines the process and responsibilities for handling facility inspections conducted by FDA, Notified Bodies, Government Agencies and other third-party inspections.

Facility Inspection Procedure - Overview

The Facility Inspection Procedure identifies assigned inspection personnel and alternates, assigns responsibilities for multiple types of inspections. The Facility Inspection Procedure provides instruction on inspection restrictions and the proper internal handling of facility inspections and inspectors. The procedure also includes instruction on exit interviews, and timelines for required post inspection activities.