Sample reports

The reports, as a customer receives them.

The platform generated both from a demo device manufacturer's records. No figure in them was entered by hand.

About the demo manufacturer. Tessaline Orthopedics produces orthopaedic implants and instruments. Its quality manager has gone, internal audits stopped during the move to the QMSR, and both an FDA inspection and an ISO 13485 surveillance audit lie ahead.

Audit Defense Pack

For the auditor or investigator · PDF, evidence ZIP and register workbook

A readiness score for each clause of ISO 13485:2016, with the QMSR alongside
For every finding, the clause it fails and the record that shows it
A ranked action plan, each action with an owner and a due date
A list of what the records could not demonstrate, rather than a guess
An auditor's checklist: likely questions on each clause with a gap, and the evidence to have ready
An evidence index arranged by clause, with a file manifest

Sample report excerpts are being refreshed and will be back here shortly. To see one now, book a call.

Download the self-audit workbook (XLSX): every ISO 13485 question in the set, with those covering Tessaline's gaps at the top.

Quarterly Business Review

For management review · PDF

Quality status on a page your executives will read
The decisions you need leadership to make
Which actions sit behind each decision
Ready to take into management review (ISO 13485 5.6)

Sample report excerpts are being refreshed and will be back here shortly. To see one now, book a call.

What the sample shows

Each item below is traced, inside the pack, to a record of Tessaline's.

Yours is built from your records alone, so the numbers in it will be yours.

A readiness score out of 100 against ISO 13485:2016 and the QMSR, broken down by clause
Open findings from audits, nonconformances, complaints and self-assessment, each tied to its clause and record
CAPAs that are open or overdue, and whether each had an effectiveness check
Complaints with no documented MDR reportability decision, and design changes with no verification or validation record
Suppliers, gauges and validated processes that sit behind more than one finding, ranked at the top
An audit checklist: what an auditor or FDA investigator is likely to ask on each clause where Tessaline's records fall short

We regenerate the samples from Tessaline’s records each time the reports change. A real pack also carries the evidence ZIP and the registers workbook (XLSX), not shown here; the self-audit workbook above is taken from that ZIP.

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