QMSR inspection preparation: records and US-specific quality-system requirements
The acquired current eCFR text in 21 CFR 820.10, 820.35 and 820.45 provides concrete preparation tasks: document the applicable quality system, map US-specific regulatory links, assemble complaint/servicing records, and control labeling/packaging. Scope remediation against actual records rather than an obsolete future-transition checklist.
Evidence retrieved 2026-10-06. Source versions and topic-specific limits are listed below.
Sourced criteria · US
What changes the service scope?
Decision or task
What the source describes
What to prepare
Which quality-system requirements apply?
Section 820.10 links the documented system to applicable ISO 13485 requirements and other Part 820 requirements; it separately describes design/development and life-supporting-device conditions. [1]
Map actual manufacturer/device facts to scope before assigning remediation; use a properly licensed standard for its full text.
Which US regulatory links need records?
Section 820.10(b) identifies UDI, applicable traceability, complaint reporting and advisory-notice links to other FDA parts. [1]
Trace each applicable link to owned procedures and records instead of treating certification as the entire FDA assessment.
What complaint and servicing evidence is specified?
Section 820.35 sets additional information for complaint, servicing and UDI records, including justified decisions not to repeat a similar complaint investigation. [2]
Sample actual records for the specified information, investigation decisions and links to corrections.
How are labels and packaging released?
Section 820.45 describes integrity/control procedures, accuracy checks, documented release and prevention of mixups. [3]
Walk through an actual release with identifier, expiry/storage/handling information and inspection records.
The manufacturer’s applicable scope, licensed standard requirements and gaps remain incomplete. This sourced record plan is not a certification, inspection outcome or complete audit of every applicable FDA part.
A scoped evidence and handoff plan
Use this checklist to gather your business or product details before speaking with a specialist. The items below explain what to record and suggest useful supporting documents. You can add your own answers in the editable project brief.
Which quality-system requirements apply?
Map actual manufacturer/device facts to scope before assigning remediation; use a properly licensed standard for its full text.
Useful evidence: Quality-system scope, device/design context and clause-to-record matrix.
Which US regulatory links need records?
Trace each applicable link to owned procedures and records instead of treating certification as the entire FDA assessment.
Useful evidence: UDI/traceability, reporting and advisory-notice procedures with record examples.
What complaint and servicing evidence is specified?
Sample actual records for the specified information, investigation decisions and links to corrections.
Useful evidence: Complaint/servicing samples, investigation justifications and UDI linkage.
How are labels and packaging released?
Walk through an actual release with identifier, expiry/storage/handling information and inspection records.
Useful evidence: Label/packaging procedures, artwork, release and inspection records.
Work packages and dependencies
Conditional: Record sampling, gap assessment and remediation scope — For this work package, agree the supported criteria, evidence access, covered entities/products and unresolved facts in the table above. Additional services require their own justified scope.
Optional: Software procurement for demonstrated record/control gaps — For this work package, agree the supported criteria, evidence access, covered entities/products and unresolved facts in the table above. Additional services require their own justified scope.
Questions for providers
Which exact actor, product or processing facts support the quoted scope, and what is still unresolved?
How will the listed records reach the responsible people, and who owns each change or authority request?
Which tasks and entities are excluded from the agreement, and which additional services need a separate assessment?
Sources and data dates
Read the official document in context. The audit details identify the precise locators and preserved versions used for this page.
