How Aligntra reads a quality system
A review reads your documents against the clauses of your standard and cites each finding to the passage it came from. Your auditor decides what happens to each one.
ISO 13485:2016 · run on the published example QMS
Verification plans lack documented acceptance criteria, statistical techniques, and sample size rationale
Nothing is sampled
Once a document is mapped to a clause, it is reviewed against that clause.
Upload PDFs and Word files as you keep them, or connect Google Drive. No migration, and no naming convention to adopt.
- Clauses are matched to documents before any document is judged
- A clause with nothing behind it is recorded as a gap
- One run, two paths: procedures against clauses, records against their procedures
Findings cite a page and a paragraph
A finding names the clause, the file, the page and the paragraph it relies on.
- The quoted text is checked back against the document it came from
- Located in the PDF by coordinate, including text set inside tables
- Opening a finding opens the source at that page, passage highlighted
- A quote that cannot be located is flagged for review
- Clause wording comes from a stored copy of the standard. The model is not asked to produce it
Your auditor decides
A person confirms, dismisses or reclassifies each finding.
- Nothing is closed automatically
- The record stores the citation and the decision together
- Related clause failures are consolidated into one finding
- Observations are listed with the findings and do not block a verdict
- The readiness verdict follows the findings your auditor confirmed
At the end of a run
Four things, all of them exportable, all of them carrying the citation that produced them.
A coverage map
Which clauses were assessed, which documents were read against each, and which have nothing behind them.
Findings with citations
Major and Minor non-conformities and observations, each cited to a file, a page and a paragraph.
Audit questions
Eight to twelve questions drawn from your own procedures, each quoting the SOP it came from.
"SOP-DC-001 §6.5 requires test results to be documented and reviewed. Show me the verification plan for the most recent design change and the acceptance criteria it was judged against."
An exportable record
Coverage, findings and the readiness verdict in one file, with a marked-up copy of the sources showing each finding in place.
See it on the example QMS
The same review, on the published example audit.