IVD QMSR Inspections: Are Internal Audit and Management Review Records Accessible?
FDA’s QMSR FAQs state that management review, quality audit, and supplier audit reports are inspectable. The former Part 820.180(c) exceptions were not retained.
Use the current inspection framework
QMSR became effective on February 2, 2026. FDA says inspections under the new framework can include quality-system records created before that date. The former exception for certain management-review and audit reports should not be treated as a continuing blanket refusal basis.
For an IVD manufacturer, the practical question is whether the relevant records are complete, controlled, and retrievable under the applicable quality system. An ISO 13485 certificate does not exempt a manufacturer from FDA inspection.
Prepare the actual records, not a replacement presentation
- Identify the current and retained management-review records.
- Locate internal quality-audit reports and follow-up records.
- Identify supplier audit reports maintained as part of the quality system.
- Confirm the responsible record owners and access arrangements.
- Train the inspection team to route a request to the appropriate person.
Preserve the record and its context
A readiness review can check whether actions have owners, follow-up is traceable, and referenced evidence can be located. That is a practical preparation approach, not a reason to recreate a cleaner version of an old report or remove unfavorable findings.
Keep original records and documented corrections according to the applicable controls. If a record identifies an unresolved issue, prepare an accurate explanation of the current status and available evidence rather than an unsupported assurance that the issue was fixed.
Do not confuse FDA inspection with a certification audit
FDA explains that its QMSR inspections do not follow the MDSAP audit plan or procedures and that FDA does not require or issue ISO 13485 certificates of conformance. Prepare for the regulatory requirements applicable to the product and operation, rather than assuming a prior certification audit determines the scope of FDA review.
Questions about a particular request should be assessed in context. This article addresses the published QMSR policy on these record categories; it is not a universal conclusion about every record an investigator may request.
Related inspection resources
Primary sources
Sources reviewed October 20, 2026. The preparation steps above are practical suggestions; the linked regulations and FDA documents define the applicable requirements.