My workspace doesn't show ISO 9001 or ISO 13485. Is Quality missing?
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.
If I approve my procedure's document, does its task update on its own?
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.
Do ISO 9001 and ISO 13485 keep separate task lists?
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.
Is Controlled documents switched on for every workspace?
Is Controlled documents switched on for every workspace?
No. It’s switched on per workspace. See Make a document controlled.
Are e-signatures required for controlled documents?
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.
Can an external reviewer approve a controlled document without an Assuric account?
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.
How do I give an auditor access?
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.
Is there a dedicated CAPA module?
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.
How long do I need to keep CAPA records?
How long do I need to keep CAPA records?
Keep them for 5 years, per UK MDR 2002, whichever framework they’re logged against.
Can AI make changes to my QMS directly?
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.
Who can review and approve a controlled document?
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.
Does ISO 9001 track non-conforming product the same way ISO 13485 does?
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.
Related articles
Quality: Overview
What the section covers and how it’s structured.
Procedures and records
Procedures as documents behind policy tasks, and the records that prove you follow them.
CAPA and non-conformances
What is tracked today, and what is still being built.