ISO 13485 document control

ISO 13485 Document Control Software Guide

ISO 13485 document control depends on more than storing files. Teams need controlled approvals, released versions, training impact, review schedules, and evidence that shows the right procedure was effective at the right time.

Separate document titles from original file names

Quality teams often need a clean controlled title while preserving the original uploaded file name for traceability.

Control draft, approval, effective, and archived states

A document control system should make it clear when a document is draft-only, pending approval, effective, superseded, or archived.

Tie periodic reviews to operating queues

A next review date is only useful when it becomes visible to owners before it is due and remains traceable after completion.

Connect released documents to training

When a controlled procedure changes, training assignments and acknowledgements should reference the released version that created the obligation.

FAQ

Common questions

What should ISO 13485 document control software manage?

It should manage controlled titles, versions, approvals, release status, effective dates, periodic review dates, training impact, controlled copies, and audit trails.

Does document control software replace shared drives?

It should replace shared-drive file tracking for controlled documents, while preserving files, metadata, approvals, history, and evidence in a controlled workflow.

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Walk through the workflows behind this guide.

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