Supplier Audits in Türkiye & Europe
Purchasing controls only work if critical suppliers are actually evaluated, and flying an auditor in for one day is expensive. We audit your suppliers on site in Türkiye and Europe against ISO 13485 and your own requirements, and deliver a structured report your supplier file can rely on. Under the QMSR, those supplier audit reports are also open to FDA review.
Qualification audits
Initial audits of new suppliers of components, materials, sterilization, packaging or contract manufacturing.
Surveillance and for-cause audits
Periodic re-evaluation, or a focused audit after a complaint, nonconformance trend or change at the supplier.
Your checklist or ours
We audit against ISO 13485 and your quality agreement, using your template if you have one.
Structured reporting
Findings with objective evidence, risk grading and a clear recommendation on supplier status.
FAQ
Where can you audit on site?
Throughout Türkiye and in Europe. Travel costs are quoted transparently up front.
Do you have conflicts of interest with suppliers?
We run a conflict-of-interest check before every engagement and decline audits where we have a relationship with the supplier.
Other services
Remote Internal Audits
Independent ISO 13485, QMSR and MDR internal audits with reports written to withstand an FDA or notified body read.
QMSR Gap Analysis
Check your ISO 13485 system against the FDA QMSR and related US requirements, with a prioritized action plan.
ISO 13485 Quality Management System
One QMS built to serve EU MDR, FDA QMSR, Türkiye and Gulf requirements: set-up, upgrade and training.
EU MDR & CE Marking
MDR transition, technical documentation, GSPR, ISO 14971 risk management and notified body preparation.
Validation
Sterilization validation, test method validation, cleanroom and process validation reviews.
CAPA & Quality Processes
CAPA, nonconformance, complaints, document control, batch record review and product release.
Let’s map your route to market in 30 minutes
Tell us about your device, target markets and timeline. You’ll leave the call knowing which requirements apply, where your gaps likely are and what to do first.