360 Audit, Identify gaps before the internal audit | Sparta Care
Solutions/Product · 360 Audit

Identify gaps before the internal audit.

Analysis of your Quality Management System to identify gaps against ISO 13485. Potential non-conformities are prioritized by criticality, ready to be addressed ahead of the internal audit.

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The challenge

The internal audit reveals gaps that should have been addressed earlier.

The internal audit arrives and gaps pile up: outdated procedures, missing records, poorly covered requirements. Each non-conformity opens a CAPA, takes up time, and delays the Notified Body audit. The earlier these gaps are identified, the simpler the remediation — but you need to be able to detect them without re-reading the entire QMS line by line.

Our solution

An ISO 13485 diagnostic in hours.

360 Audit analyzes your entire QMS and compares it against ISO 13485 requirements. Gaps are identified, classified by criticality, and presented with the exact normative reference. You arrive at the internal audit with a prioritized action list rather than surprises.

01 · Connection

Connecting to your document repository

360 Audit connects to your document repository (Confluence, Notion, SharePoint) and indexes all QMS procedures.

02 · Analysis

Comparison against ISO 13485

Each clause of the standard is compared against your QMS: document coverage, process consistency, and record traces.

03 · Gaps

Prioritization by criticality

Potential non-conformities are classified as critical, major, or minor, based on their impact on compliance and product risk.

04 · Reference

Precise normative reference

Each gap cites the relevant ISO clause and the deficient procedure or record, ready to be fed into the action plan.

05 · Action plan

Ready for the internal audit

The output from 360 Audit directly feeds your management review and pre-audit action plan, with no re-entry needed.

Ecosystem

Natively connected
to your stack.

Our tools plug directly into your existing environment. No parallel platform to manage, no data migration. Each component integrates right where your teams already work.

Confluence
Jira
Slack
Microsoft Teams
Google Drive
Notion
SharePoint
Sovereign AI

A European AI, at the service of your compliance.

The Sparta Care Suite is powered by Mistral, the European sovereign LLM. A high-performing AI, rooted in the European artificial intelligence ecosystem.

Powered by
Mistral AI
01
Secure servers in Europe
Sovereign hosting, end-to-end encryption, GDPR compliant.
02
Zero data retention
Your documents are never stored or used to train the model.
03
Contractual confidentiality
Non-disclosure agreement signed before any documentation handover.
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Certifications & partnerships
GMED certified
for QMS internal audit
BPI France
experts