Your notified body samples. Aligntra reads everything.
All of your procedures and records, read against ISO 13485, FDA QMSR, EU MDR and ISO 14971, and a contract manufacturer’s documents on the same engine. Each finding cites the document, the page and the paragraph it came from.
A CAPA may be initiated from internal audit findings, nonconforming product reports and customer complaints.
Post-market surveillance and vigilance are not listed as CAPA inputs.
The CAPA record is closed once the corrective action is complete.
No review of effectiveness is required before closure.
The CAPA file shall contain the investigation report, the action plan and the verification record.
No update to the risk management file is required at closure.
Sampling is a schedule decision.
Sample size is left to auditor judgement, and the judgement is made against a calendar. Reading two hundred CAPA records by hand takes a month, so an auditor reads five.
Hypergeometric, 200 records, sample of 5. Reading all of them removes sampling error; analysis error remains.
Run the same engine on a supplier’s quality system.
Their procedures sit inside your §7.4 supplier controls, so their gaps become your findings. A questionnaire records what a supplier says about its own procedure. Reading the procedure tells you whether the procedure says it.
- That a CAPA procedure exists, and its document number.
- That someone at the supplier ticked a box saying it is controlled.
- A revision date, which you cannot check.
- Nothing about what any clause of it actually requires.
- Whether closure requires an effectiveness check, and at which paragraph.
- Which of your standard’s clauses the document leaves unanswered.
- Whether the revision you were sent is the one the procedure references.
- A finding you can put in front of them, cited to their own page.
The questionnaire qualified the supplier. Reading the same procedure is the audit you owe your own certificate, and it is the week of reading nobody has time to do.
Four standards read the same documents and ask different things.
Each standard is a separate audit against the same document set. FDA QMSR incorporates ISO 13485 by reference, so most of those two runs are one requirement set with a short list of FDA-specific additions on top. EU MDR and ISO 14971 are where the same procedures are asked something new.
The standard your certificate is issued against.
Incorporates ISO 13485 by reference, plus FDA-specific clauses.
Regulation 2017/745, indexed by obligation.
Risk management, referenced by the other three.
Surveillance annually, recertification on a three-year cycle.
Inspection at the agency’s discretion.
Notified body assessment on the certificate cycle.
Assessed within the audits above.
*In beta. Available for audits and marked as beta in the product.
MDSAP is an audit approach over ISO 13485 rather than a fifth standard: 90 tasks, accepted by the regulators of Australia, Brazil, Canada, Japan and the United States. FDA QMSR has applied since 2 February 2026.
Three approaches in current use, and what each one leaves.
Engage a consultant
A consultant reviews a selection of your documentation during a site visit of one or two days.
Coverage is limited to the documents that fit the engagement.
Maintain a compliance matrix
A clause-to-procedure matrix records which document answers which requirement, per standard.
Whether the document meets the clause goes unassessed, and the matrix needs updating after each revision.
Rely on the certification audit
Your notified body samples documentation at surveillance and recertification, one standard per audit.
Findings are raised on site, within the audit.
Read all of it first
All of your documents, and your supplier’s, read against the full clause set and cited to the paragraph.
A reviewer in your organisation confirms, reclassifies or dismisses each finding before it enters a report.
Run a review against your own documentation.
Aligntra reads your procedures against ISO 13485, FDA QMSR, EU MDR and ISO 14971, and reports each finding with the document, page and paragraph it was drawn from.