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Supplier audits

Supplier audits your notified body will trust.

ISO 13485 audits of your suppliers and contract manufacturers, on site or remote, by certified lead auditors who have sat on both sides of the table.

€1,200 per auditor day. Usually 1 to 2 days per supplier, report included, travel at cost.

Book a call about a supplier audit What you get

Free · 20 minutes · no obligation. You leave with a clear first step.

Not sure who you need? Take the one-minute quiz

When you need one If one of these sounds familiar, a 20-minute call is worth it.
A new critical supplierYou are adding a contract manufacturer or a critical component supplier and need it audited before you approve it.
Your annual programmeISO 13485 asks you to control your suppliers. Your audit schedule says it is time, and your team has no capacity.
Something went wrongA nonconformity, complaint or recall traces back to a supplier and you need to know what happened there.
Your auditor is comingYour notified body or certification body will ask for evidence that you control your critical suppliers.
What you get Scope, deliverables and price in writing before any work starts. Prices exclude VAT.
Single audit

One supplier audit

€1,200 per auditor dayUsually 1 to 2 days, report included, travel at cost

For a new supplier to approve, or one that needs a closer look.

  • Audit plan and scope agreed with you and the supplier
  • On-site or remote audit against ISO 13485 and your requirements
  • Graded findings with objective evidence
  • A supplier risk rating and a report ready for your supplier file
Book a call about a supplier audit
Programme

Your supplier audit programme

from €4,800per year · four audit days, scoped by number of suppliers

For companies with several critical suppliers who want the whole programme planned and run.

  • A risk-based audit schedule for all your critical suppliers
  • Every audit run and reported to the same standard
  • Follow-up of supplier corrective actions
  • A yearly overview for your management review
Book a call about your programme
How it works Four steps, and you know the price at the second one.
01Book a free call

Twenty minutes to understand where you are and what you need.

02Scope and price in writing

A short proposal with the scope, the dates and a fixed price.

03We do the work with you

On site or remote, alongside your team, so nothing stops.

04Report and next steps

A clear report, a read-out, and the next steps in priority order.

Who leads it The founders do the work themselves.
Chani Galgut, co-founder of Niavicta

Chani Galgut leads supplier audits: a CQI/IRCA certified ISO 13485 lead auditor who audits where the work happens, from the production floor to the warehouse and the IT systems behind them. Experience across robotics, implantable devices, IVDs and combination products. Jasmine Beukema joins where the supplier relationship touches your regulatory strategy.

Questions The ones people ask on the first call.
Do you travel to suppliers?

Yes. We audit on site across the Netherlands and the EU, with travel charged at cost. Remote audits are possible where the scope allows it.

Can you audit suppliers outside the EU?

Yes, remotely, or on site by agreement. We scope that on the first call.

Do you sign an NDA?

Yes. We sign your NDA, and the supplier's where they ask for one.

What happens after the audit?

You receive graded findings with evidence and a supplier risk rating. If you want, we follow up the supplier's corrective actions until they are closed.

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Twenty minutes tells you where you stand.

Book a free call. You leave with a clear first step, whether or not you work with us.

Book a call about a supplier audit All services and prices