Supplier audits

Review a supplier’s documentation before you get on the plane.

It is the same review, aimed outward at a quality system you have never seen and cannot walk.

The situation

A tier-two supplier sends two hundred records and a folder of procedures ahead of an on-site visit. You have a day to prepare and no way to read all of it.

The difference

The same supplier gives two different answers

A questionnaire records what a supplier says about its own procedure. Reading the procedure against the standard shows whether it actually meets the obligation, and the two answers often disagree.

What a questionnaire tells you
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
What Aligntra checked for

Whether a corrective action has to be verified as effective before the record can be closed, not only implemented.

ISO 13485:2016 · §8.5.2 — our check, stated in our words
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 answered yes for, read against the standard.

The questionnaire qualified the supplier, and reading the same procedure produced a major nonconformity.

Beforethe week ahead of the visit

They send what they have; you read all of it

Supplier documents arrive in whatever structure they keep. Procedures and records are reviewed against the applicable standard — not a sample of them, and not only the ones you had time for.

29documents read
212clauses in scope
0sampled
the example QMS · ISO 13485:2016
Duringpreparing the agenda

The exceptions arrive cited

Each finding names the clause, the document, the page and the paragraph. You walk in with a list of things to ask about and the evidence already open.

Issues queue showing supplier findings, each cited to a clause, document, page, and paragraph
On sitethe visit itself

The visit is spent on what documents cannot show

The documentation half is already done and defensible, so the on-site hours go to process observation, operator interviews and the floor instead of paperwork.

Afterthe record

The record keeps the citation and the verdict

Each finding carries the passage it stands on and the decision your auditor made about it — exportable, and legible to someone who was not in the room.

36findings
8Major NC
28Minor NC
the example QMS · ISO 13485:2016

See it on a supplier’s documents

Bring a folder from a real supplier pack and we will run it live on a thirty-minute call.