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Quick summary
  • One shared task, CAPA records maintained, holds your CAPA records across all enabled frameworks.
  • There’s no CAPA module yet: you keep the log in Assuric’s CAPA Log template.
  • Keep CAPA records for 5 years.

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Open the CAPA task

Go to Frameworks → your framework → the Tasks tab, filter for CAPA and select CAPA records maintained.

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What Assuric tracks today

A non-conformance is one instance of something not meeting requirements, and a corrective and preventive action (CAPA) formally investigates why. Each framework has its own CAPA procedure task but shares one record task, CAPA records maintained. With Class I UK MD (low-risk software as a medical device) enabled, the same task counts towards that framework too. Download the CAPA Log template from the task.
The ISO 9001 Tasks tab filtered to "record", with CAPA records maintained highlighted
Filtering to “record” (1) surfaces CAPA records maintained (2), the one task doing duty across every framework that asks for it.

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Limits

  • There’s no CAPA module, so no intake form, workflow or dashboard. You keep the log yourself, in Assuric’s CAPA Log template, and the task tracks that you’re doing it.
  • Retention is 5 years, per UK MDR 2002, whichever framework the record is logged against.

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Non-conforming product

Only ISO 13485 has a separate task for this, SOP Control of Non-Conforming Product maintained. ISO 9001’s CAPA procedure covers nonconforming outputs (8.7) and nonconformity and corrective action (10.2), and its records go in CAPA records maintained.
The ISO 13485 Tasks tab filtered to "non-conform", showing the single matching task
Filtering ISO 13485 to “non-conform” (1) turns up exactly one task (2). It doesn’t exist on ISO 9001.

Audit and review records

Where CAPAs and findings usually come from.

Procedures and records

The CAPA procedure task points at a document like any other.

Quality FAQ

Quick answers to the things customers ask us most.