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Quick summary
  • Quality is your QMS for ISO 13485 and ISO 9001, built to stand up to an ISO audit.
  • Assuric enables ISO 9001 or ISO 13485 for you; you can’t turn either on yourself.
  • Auditors get read-only access, so there’s nothing to export when the certification body arrives.

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Open Quality

In the sidebar, under Areas, click Quality if your workspace has access. Its frameworks are also under Compliance → Frameworks: ISO 9001 or ISO 13485, whichever Assuric has enabled for your workspace. You can’t turn one on yourself.

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The frameworks Quality follows

ISO 13485 is the quality management standard certification bodies and regulators expect if you make, develop or supply a medical device. ISO 9001 is the general standard. ISO 13485 shares much of its structure, so if you’re certified to both, you run one quality management system (QMS). ISO 13485 adds substantially more, most of it scoped per product.
The Frameworks overview grid, with the ISO 9001 and ISO 13485 cards highlighted
ISO 9001 (1) and ISO 13485 (2) each sit on the same grid as every other framework in your workspace, with their own percentage complete and task count. Each standard’s clauses are on its Requirements tab, backed by tasks, so working through the tasks builds a complete QMS that traces every piece to its clause.

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Who owns what

Assuric ships a written definition for each QMS role, on the Roles tab under People → Roles & Groups. Permissions and access explains how roles differ from permission levels.

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What Assuric does automatically

Evidence is collected as you work, so there’s nothing to export.

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What’s in this section

Documents: Overview

The document library every procedure lives in.

Roles and groups

The standard roles, and what roles are used to assign.

Framework progress

How the Requirements/Tasks split works across every area.