Internal Audits vs External Medical Device Facility Inspections
Internal audits assess the organization’s quality-system processes against defined criteria. External facility inspections involve a regulator, notified body or other outside party and require a controlled response process. Preparing for both means making evidence retrievable and keeping findings connected to effective action.
Audit the process and its evidence
Define scope, criteria and suitable auditors, including independence from the work being evaluated. Follow a process through its records and interfaces rather than check only whether a procedure exists. Record findings with enough objective evidence that the process owner can understand and investigate the issue.
Manage the inspection and follow-up
Assign coordination, request handling and communication responsibilities for external inspections. Provide accurate records and track information supplied. Review findings, investigate their extent and define justified actions. FDA stopped using QSIT on February 2, 2026 and moved to its updated device-manufacturer inspection process, so older inspection assumptions need review.
Practical checklist
Define audit scope and criteria.
Assign qualified and suitably independent auditors.
Sample actual process records and interfaces.
Coordinate external requests and supplied records.
Investigate findings and assess action effectiveness.
Example
An audit may find that supplier approval is documented but purchasing routinely uses suppliers outside the approved scope. Following the actual order and receiving records reveals the interface issue that a procedure-only review could miss.
Common mistakes
Avoid turning every finding into a document edit without assessing the operating cause. Updating wording is useful when the instruction is deficient; it does not resolve a process that consistently bypasses an adequate instruction.
Choose the relevant A.P. Lyon documents
Use internal-audit documentation for auditor independence, scheduling, criteria, evidence, findings and follow-up.
Use facility-inspection documentation for preparation and coordination of FDA, notified-body and other external inspections.
Review the product page, document previews and any content list before choosing. Adapt the selected documents to your device, processes and applicable requirements; the organization must generate and review its own implementation evidence.
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