Find every ISO 13485 gap before your auditor does.
What Gordios checks in your quality management system, and why it matters.
Book a demoISO 13485 in practice: a living system, not a binder.
ISO 13485 isn't a set of documents produced once for certification. It's a quality management system that has to run every day — and whose records have to prove it did.
A system, not a set of documents
Procedures, the Quality Manual, work instructions — they only matter if they describe what actually happens. A QMS that exists on paper but not in practice is the first thing an experienced auditor uncovers.
Records prove the process ran
Every requirement of the standard expects evidence: training records, review minutes, CAPA files. A procedure without the records that show it was followed is a finding waiting to happen.
Management review and improvement
Management review and continual improvement are at the core of the standard. Reduced to an annual formality with no real inputs, outputs or actions, they become a visible weakness in the system.
Links with the rest of the file
Risk management (ISO 14971), design controls and the technical documentation must stay consistent with the QMS. A QMS that drifts from the technical file creates silent inconsistencies — hard to detect, costly in audit.
What Gordios examines, point by point.
Every check is located in your documents. Every gap is explained — not a global score, but a traceable, actionable result.
| Domain checked | What Gordios verifies | Coverage |
|---|---|---|
| QMS & documentation | Quality Manual, scope and justified exclusions, document and record control, version management | Audited |
| Management responsibility | Quality policy and objectives, responsibilities and authorities, management review inputs and outputs | Audited |
| Resources & competence | Competence requirements, training records, infrastructure and work environment controls | Audited |
| Design & development | Design inputs and outputs, verification and validation, design transfer and changes, design history file | Audited |
| Purchasing & suppliers | Supplier evaluation and monitoring, purchasing information, verification of purchased product | Audited |
| CAPA & improvement | Nonconforming product, complaint handling, CAPA with effectiveness checks, internal audit, regulatory reporting | Audited |
The chain every auditor follows.
A requirement only holds up when it can be traced end to end. Gordios checks that the chain is unbroken.
ISO 13485 analysis points
of audit-prep time saved
to your first report
They trust us
Gordios was a game-changer in setting up our quality system.
Dr Céline BesnierCEO, SportSantéClicWe saved time and money by bringing Gordios in from the very start of development.
Andrea BallarinCEO, Hippocrate CareHow Gordios audits your QMS.
Three steps, on your real documents. No configuration, no prior training needed.
You import your documents
Quality Manual, procedures, records, design file, supplier and training documentation — you upload what you have. Gordios adapts to your documentation structure.
Gordios audits against the 13485 grid
The tool verifies every point of the standard against your documents: presence, consistency, traceability. Automatically, with no manual intervention.
You receive a traceable report
Every result is located in your documents. Every gap is explained. You know what holds up and what needs attention — with the exact source to back it up.
The most frequent gaps Gordios detects.
Not poorly-made files — but systems documented without the auditor's perspective.
Procedures that don't match practice
The procedure describes one process. The team runs another. The gap stays invisible until an auditor follows a record end to end.
Management review as a formality
Minutes exist, but without the required inputs, measurable outputs or follow-up actions. The review happened on paper, not in the system.
CAPA closed without effectiveness check
Corrective actions are recorded and closed — but nothing proves they actually worked. The effectiveness verification the standard requires is missing.
Competence records that don't cover critical tasks
People perform activities affecting product quality, but the training and competence records that justify it can't be produced.
Supplier control that exists only on a list
An approved supplier list is in place, but the evaluation, monitoring and re-assessment evidence behind it is thin or absent.
Document control drift
Obsolete versions stay in circulation, uncontrolled copies appear, and the link between a record and its current procedure is broken.
ISO 13485 audit — common questions.
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