Internal · supplier · certification audits — one platform

One AI that audits your QMS — and your suppliers'.

Internal audits, supplier audits, certification prep — Aligntra reads every page against the standard and cites the exact paragraph behind each finding. No sampling, 30 minutes.

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First audit in 30 min No QMS migration Encrypted at rest + in transit We never train on your documents

ISO 13485 · §7.4.1 · finding #4814 MAJOR NC

Your supplier SOP qualifies suppliers AFTER they ship. The standard requires it before.

What the standard says

"…criteria for the evaluation and selection of suppliers… based on the supplier's ability to provide product that meets the organization's requirements…"

ISO 13485:2016 · §7.4.1(a)

What your doc says

"Suppliers shall be audited after receipt of the first shipment of conforming product. Initial PO may be issued based on the supplier's stated capabilities."

SOP-PUR-002 Rev 04 · p. 7 §5.2

The gap

SOP inverts the sequence required by the standard. Selection must follow evaluation, not precede it. Your procedure issues POs on the supplier's own claims and audits only after product is already in your supply chain.

EVERY CLAUSE, CITED

See it on a real document

Each finding links to the exact line.

No retyping, no hunting. Aligntra cites the precise passage and highlights it in your source document — so the evidence is one click away.

A Major NC on ISO 13485 clause 7.5.1 product release in Aligntra, with the cited shipping-method passage highlighted in the source SOP beside the finding and its analysis.

A real Major NC on §7.5.1 product release — the cited shipping-method passage highlighted in the actual SOP, beside the finding and its analysis.

WHAT WE READ AGAINST

Nine standards. All indexed.

280 clauses

290 clauses

431 clauses

141 clauses

283 clauses

234 clauses

350 clauses

2,157 clauses indexed · 4 live · 5 beta Browse all standards →

One model · three audits

Internal, supplier, certification — read off one evidence model.

Internal audits

Audit your own QMS for 100% clause coverage. The week-long read, done in 30 minutes.

Supplier audits

Audit a supplier's QMS the same way — clause by clause, cited — before the first PO.

Certification prep

Run the audit your registrar will run, and know what they'll find before they walk in.

ISO 19011 recognizes three audit types. Most tools serve one. A finding from your internal audit surfaces during cert prep — same evidence, same readiness math. Three audits, one record.

THE DASHBOARD

Every clause. Every revision. Every audit.

One run shows you what 47 documents say about 309 clauses. Without sampling.

● app.aligntra.com/audits/iso-13485-2026q1

LIVE

‹ ALL AUDITS ISO 13485 Audit · ISO 13485:2016 · Internal · Design Control

EXPORT ▼ ▶ RE-RUN

Summary Coverage Documents 47 Issues 35

● ACTION REQUIRED

3 Major NCs

CLAUSES ANALYZED

297/309

96% COVERAGE

COMPLIANCE

87%

OF ANALYZED

DOCUMENTS

8,143 PAGES

FINDINGS

3 MAJOR · 14 MINOR · 18 OBS

SECTION COVERAGE — ISO 13485 VIEW ALL SECTIONS →

§4 Quality management system 37 of 37 ● 1 Major ● 3 Minor ● 4 Obs 100%

§4.2

§5 Management responsibility 26 of 26 ● 1 Major ● 4 Minor ● 0 Obs 100%

§5.5

§6 Resource management 13 of 13 ● 0 Major ● 2 Minor ● 0 Obs 100%

§6.4

§7 Product realization 87 of 87 ● 1 Major ● 4 Minor ● 6 Obs 100%

§7.3

§8 Measurement, analysis & improvement 29 of 39 ● 0 Major ● 1 Minor ● 3 Obs 74%

§8.2

WHAT ALIGNTRA DOES

Three steps. First audit in 30 minutes.

No migration. No restructuring. We read the QMS you already have — yours, or a supplier's.

Ingest

SOP-QMS-001.pdf Indexed

SOP-CAPA-002.docx Indexed

PROC-DOC-003.pdf Indexing

STEP 01

Connect your documents

Drag and drop PDFs and Word docs — or connect Google Drive. We index the controlled docs you point us at.

Standards

ISO 13485:2016 309 clauses

FDA QMSR (21 CFR 820) 333

AS9100D 352

+ 6 more standards

STEP 02

Pick a standard

ISO 13485, FDA QMSR, AS9100D, ICH Q10 — any of the 9 we support. We read the requirements and find evidence in your docs.

Audit trail

§4.2.4 Control of records Compliant

§7.4.1 Supplier evaluation Observation

§8.5.2 Corrective action Major NC

Cited: para 4, p.12, line 4

STEP 03

Get an audit trail

A clause-by-clause report with the exact paragraph cited for each one. Compliant, observation, or nonconformity. Hand it to your auditor.

HOW WE'RE DIFFERENT

We're not replacing your eQMS. We're the layer that reads it.

Traditional eQMS

Aligntra

WHAT IT DOES

Replaces your document system

Sits on top of existing documents — reads them

IMPLEMENTATION

6–18 months — migrate your whole QMS

30 minutes — point at a folder, run the first audit

AUDIT PREP

Configure workflows, train users, build reports

Click Run — get a clause-by-clause report with citations

PRICING

$50K–$500K + implementation + per-seat

$499–$1,499/month, published online

No sampling

Your entire QMS, analyzed in 30 minutes.

Internal auditors sample under ISO 19011 §6.4.7. Aligntra reads every document in your audit — SOPs, CAPAs, complaints, batch records, training files. No sampling. The same holds on a supplier's QMS you're seeing for the first time — where you'd sample hardest, it reads all of it.

100%

Records read

Minutes to run

Audit your suppliers

Read a supplier's quality system. Not their questionnaire.

A returned questionnaire tells you what a supplier says about itself. Aligntra reads what their QMS actually documents, against the standard — gap by gap, cited to the paragraph. The week of reading you don't have time to do on ten new vendors a quarter, done in 30 minutes.

ISO 13485 · §8.5.2 · supplier audit MAJOR NC

Their CAPA procedure closes corrective actions before verifying they worked.

What the standard requires

"…the organization shall… verify that the corrective action taken is effective and does not adversely affect the ability to meet applicable requirements…"

ISO 13485:2016 · §8.5.2

What their SOP says

"Corrective actions are closed once the containment action is implemented and recorded in the CAPA log."

SUPPLIER · QMS-CAPA-03 · p. 4 §6.1

The gap

A questionnaire asks whether the supplier has a CAPA procedure. They do — so it passes. Reading the procedure shows it closes corrective actions at containment, with no effectiveness check. The gap is in what they do, not whether they have it.

You'd have sampled five of their two hundred records. Aligntra read all two hundred — on a QMS you'd never seen before.

Book a 30-min demo →

BY INDUSTRY

Aligntra speaks your industry's vocabulary.

See the full standards atlas →

PRICING

Published prices. Honest tiers.

No per-seat upcharges. No 6-figure implementation. Start with a 30-minute first audit.

Professional

Solo QA consultant

$499/mo annual

Start free trial →

1 regulatory standard
60 analyses/month
Excel + PDF export
Evidence traceability
Email support

FOR QUALITY TEAMS

Business

Quality team

$1,499/mo annual

Book a demo →

All 9 standards
150 analyses/month
Record verification (CAPA + NCR)
White-label reports
5 users
Priority support

Enterprise

Multi-site QMS

Customannual contract

Talk to sales →

Unlimited analyses
Custom standards
SSO + SAML
VPC-isolated
Dedicated CSM

FROM YOUR OWN DOCUMENTS — OR ONE OF OURS

See an audit run in 30 minutes.

You don't upload a confidential QMS to a vendor on the first call. Bring your own documents if you're ready, or run a live audit on a published example QMS we maintain.

See it on your QMS → See pricing

One AI that audits your QMS — and your suppliers'.

Your supplier SOP qualifies suppliers AFTER they ship. The standard requires it before.

Each finding links to the exact line.

Nine standards. All indexed.

Internal, supplier, certification — read off one evidence model.

Every clause. Every revision. Every audit.

Three steps. First audit in 30 minutes.

Connect your documents

Pick a standard

Get an audit trail

We're not replacing your eQMS. We're the layer that reads it.

Your entire QMS, analyzed in 30 minutes.

Read a supplier's quality system. Not their questionnaire.

Their CAPA procedure closes corrective actions before verifying they worked.

Aligntra speaks your industry's vocabulary.

For Medical Devices

For Aerospace

For Pharma

For Manufacturing

Published prices. Honest tiers.

See an audit run in 30 minutes.