> ## Documentation Index
> Fetch the complete documentation index at: https://docs.assuric.com/llms.txt
> Use this file to discover all available pages before exploring further.

# Quality FAQ

> Quick answers to the things customers ask us most.

<AccordionGroup>
  <Accordion title="Where do I find Quality in the navigation?">
    In the sidebar, under **Areas**, click **Quality**. **ISO 9001** and **ISO 13485** are also under **Compliance** → **Frameworks**. See [Overview](/quality/key-capabilities).
  </Accordion>

  <Accordion title="My workspace doesn't show ISO 9001 or ISO 13485. Is Quality missing?">
    Our team sets framework availability per workspace. Check **Frameworks** to see what's enabled, and get in touch if you expected a standard to be there.
  </Accordion>

  <Accordion title="If I approve my procedure's document, does its task update on its own?">
    Yes. A policy task points at the document, so approving the document moves the task. Record tasks work differently: they ask for dated proof, so approving something elsewhere won't move them. See [Procedures and records](/quality/procedures-and-records).
  </Accordion>

  <Accordion title="Do ISO 9001 and ISO 13485 keep separate task lists?">
    No, though they aren't identical. Much of the work is shared, and a single task often satisfies clauses on both standards at once. Your written procedures and your product-specific work largely differ per framework. Expect a workspace with both enabled to carry noticeably more ISO 13485 tasks, most of them product-scoped.
  </Accordion>

  <Accordion title="Is Controlled documents switched on for every workspace?">
    No. It's switched on per workspace. See [Make a document controlled](/quality/controlled-documents#make-a-document-controlled).
  </Accordion>

  <Accordion title="Are e-signatures required for controlled documents?">
    No. They're an optional add-on for organisations working to FDA 21 CFR Part 11, switched on separately from controlled documents. See [E-signatures](/quality/review-cycle-and-statuses#e-signatures).
  </Accordion>

  <Accordion title="Can an external reviewer approve a controlled document without an Assuric account?">
    Not today. Reviewing and approving both need a login. Add them as a person and set their permission level to what they need. See [Permissions and access](/people/permissions-and-access).
  </Accordion>

  <Accordion title="How do I give an auditor access?">
    Add them in **People** with *View-only* permissions. There's no dedicated audit module or auditor role. See [Give an auditor access](/quality/auditor-access).
  </Accordion>

  <Accordion title="Is there a dedicated CAPA module?">
    Not yet. What exists today is the shared corrective and preventive action (CAPA) task, Assuric's guidance on it, and a downloadable CAPA Log template. There's no intake form, workflow or dashboard. See [CAPA and non-conformances](/quality/capa-and-non-conformances).
  </Accordion>

  <Accordion title="How long do I need to keep CAPA records?">
    Keep them for 5 years, per UK MDR 2002, whichever framework they're logged against.
  </Accordion>

  <Accordion title="Can AI make changes to my QMS directly?">
    No. AI can draft, update, read and summarise content to help you work faster, but a person has to review and approve it before it becomes part of the official record.
  </Accordion>

  <Accordion title="Who can review and approve a controlled document?">
    There are 4 lists, each accepting people or roles. Everyone in *Must review* and *Must approve* has to act before the cycle moves on, and the optional lists don't hold it up. See [Who reviews and approves](/quality/review-cycle-and-statuses#who-reviews-and-approves).
  </Accordion>

  <Accordion title="Does ISO 9001 track non-conforming product the same way ISO 13485 does?">
    No. Only ISO 13485 carries a separate task for it. On ISO 9001, the CAPA procedure covers nonconforming outputs (8.7) and nonconformity and corrective action (10.2), and the shared *CAPA records maintained* task holds the records. See [CAPA and non-conformances](/quality/capa-and-non-conformances).
  </Accordion>
</AccordionGroup>

## Related articles

<Columns cols={2}>
  <Card title="Quality: Overview" icon="clipboard-check" href="/quality/key-capabilities">
    What the section covers and how it's structured.
  </Card>

  <Card title="Procedures and records" icon="clipboard-list" href="/quality/procedures-and-records">
    Procedures as documents behind policy tasks, and the records that prove you follow them.
  </Card>

  <Card title="CAPA and non-conformances" icon="badge-alert" href="/quality/capa-and-non-conformances">
    What is tracked today, and what is still being built.
  </Card>
</Columns>


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