Clause-by-clause ISO 13485 documentation audits
Aligntra reads your procedures against ISO 13485:2016, and your CAPA and NCR records against the procedures that govern them. Each nonconformity cites the document, page and paragraph. Your auditors keep the verdict.
What Aligntra does against this standard
It reviews the documentation half of an ISO 13485 audit, exhaustively.
Reads the mapped documents
Procedures, records, DHF contents and supplier documents are each classified to the obligations they serve, then reviewed against all of them.
Cites to the paragraph
Findings name the obligation, the file, the page and the passage, and opens the source at that passage so your auditor can verify it in seconds.
Leaves the verdict to a person
Findings arrive unreviewed. Your auditor confirms, dismisses or reclassifies each one, and the record keeps both the citation and the decision.
Coverage across the standard
How many separately assessable obligations Aligntra indexes per section. Section titles are the standard’s own; its requirement text is not reproduced here.
Quality management system
Management responsibility
Resource management
Product realization
Measurement and improvement
We do not republish ISO 13485. You hold your licensed copy; Aligntra reads your documents against it.
What a 13485 nonconformity looks like
This finding comes from the published example QMS, a quality system you can open and check yourself. Our check sits on the left, the procedure on the right.
What Aligntra checked for
Whether the procedure documents acceptance criteria and a sample-size rationale for design verification, as §7.3.6 requires.
What the procedure says
“The project team shall determine the scope and methods of testing based on the nature of the design. Test results shall be documented and reviewed.”
What it costs to audit against ISO 13485
One standard is included at Professional. If you also audit against FDA QMSR or EU MDR, Business covers all nine at $1,499 per month.
There is no implementation fee and no migration — Aligntra reads the documents where they already live.
- Analyses per month60
- Standards1
- Users1
- Excel, PDF and JSON exportsincluded
Audit 13485 yourself
Our free ISO 13485 checklist covers 334 audit questions with objective evidence, common nonconformities and what to sample. You do not need to sign up to read it.