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SOLUTIONS · SUPPLIER AUDITS

Audit a supplier's QMS.
Not their questionnaire.

A returned questionnaire tells you what a supplier says about itself. A certificate tells you someone else audited them, once. Aligntra reads their actual SOPs and records against the standard — clause by clause, gaps cited to their procedures — in 30 minutes. The week of reading you don't have time to do on the new vendors waiting on your sign-off.

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SECOND-PARTY · BEFORE THE PO 100% COVERAGE · NO SAMPLING CITED TO THEIR PROCEDURE
finding #5212 · supplier audit MAJOR NC
ISO 13485 · §8.5.2 · CORRECTIVE ACTION

Their CAPA procedure closes corrective actions before verifying they worked.

A questionnaire asks whether the supplier has a CAPA procedure. They do — so it passes.

What the standard requires
"…verify that the corrective action taken is effective and does not adversely affect the ability to meet applicable requirements…"
What their SOP says

"Corrective actions are closed once the containment action is implemented and recorded." — SUPPLIER · QMS-CAPA-03 p.4. Reading the procedure shows it closes at containment, with no effectiveness check.

Cited to the supplier's own procedure · page + paragraph
Audit typeSECOND-PARTY
SequenceBEFORE THE PO
Coverage100% · NO SAMPLING
Run time30 MIN
THE DIFFERENCE

Same supplier. Two different answers.

A questionnaire asks whether the supplier has a procedure. Reading the procedure tells you whether it meets the standard. Most of the time the first answer is yes and the second answer isn't — and you only see the second one if someone reads the document.

What a questionnaire tells you
Supplier self-report · questionnaire
☑ Do you maintain a documented CAPA procedure? — Yes
☑ Is your QMS ISO 13485 certified? — Yes
☑ Do you control documents and records? — Yes
QUALIFIED

Three checkboxes the supplier filled in about themselves.

What reading their QMS tells you
ISO 13485 · §8.5.2 · CORRECTIVE ACTION
What the standard requires
"…verify that the corrective action taken is effective and does not adversely affect the ability to meet applicable requirements…"
What their SOP actually says
"Corrective actions are closed once the containment action is implemented and recorded."
SUPPLIER · QMS-CAPA-03 · p.4
MAJOR NC

The same CAPA procedure they checked "yes" for — read against the standard.

Both describe the same supplier, the same procedure. The questionnaire passed it. Reading it didn't.

WHY COLLECTION ISN'T QUALIFICATION

Three things a supplier file holds — and what none of them read.

Most supplier programs qualify on three inputs: a questionnaire, a certificate, and a scorecard. Each is useful. None is a read of the supplier's quality system against the standard you're held to.

The questionnaire

The supplier grading their own homework.

A self-report — accurate answers to the questions you thought to ask, about a system you can't see. It tells you what the supplier says. Aligntra reads what their procedures actually say, against the clause.

The certificate

Someone audited them once, against a scope you trust on faith.

A certificate confirms a registrar found their system adequate at one point, for a scope on the logo. It isn't your audit, it isn't current, and it won't tell you where their CAPA or design controls fall short today. Reading the documents does.

The scorecard

It measures the parts after they're in your supply chain.

Delivery, defect rate, deviation frequency — all of it is performance after the PO. A scorecard tells you how a supplier you already approved is doing. Aligntra reads the QMS before you approve them, so the call is evidenced, not earned back in nonconformities.

WHAT IT IS

An audit of the supplier's documents. Not a place to file them.

Aligntra isn't an approved-supplier list, a questionnaire tool, or a scorecard tracker — it doesn't manage your suppliers or replace your qualification workflow. It reads a supplier's QMS against the standard and tells you, clause by clause, where it falls short. The same engine you point at your own QMS, pointed at someone else's — before you put their product in your supply chain.

See it audit a supplier's QMS in 30 minutes.

Bring a supplier's documentation, or run a live audit on a published example QMS we maintain. By the end you'll know whether it catches what their questionnaire didn't.

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