Qualify
Classify suppliers, plan audits and define acceptance criteria by risk.
Supplier Audits and Agreements
Confident suppliers with controls that pass inspection
Assess, qualify and manage suppliers with practical audits and clear agreements. We build evidence and controls that hold up under ISO 13485, MDSAP and market expectations.
Qualified supply base
Evidence that vendors meet your QMS
Evidence that vendors meet your QMS
Clear agreements
Quality clauses, roles and records defined
Quality clauses, roles and records defined
Audit ready
Supplier files prepared for sampling
Supplier files prepared for sampling
Supplier performance
KPIs and issue handling under control
KPIs and issue handling under control
Scope
What we execute and what you receive
We structure audits, agreements and ongoing monitoring so regulators and auditors see consistent control across your supply chain.
Supplier activities we run
- Risk based supplier classification and plan
- On site or remote audits against ISO 13485 and your procedures
- Audit reports, nonconformities and CAPA coaching
- Quality agreements with responsibilities and records
- Incoming inspection and acceptance criteria alignment
- Change notification, requalification and escalation paths
- Performance metrics and supplier reviews
Deliverables you bring to inspection
- Approved supplier list with classifications
- Audit schedule, reports and evidence packs
- Closed actions and effectiveness checks
- Signed quality agreements and annexes
- Metrics dashboard and management review inputs
- Change control records and requalification logs
How it works
From qualification to performance review step by step
We align activities with your product risk and supplier role so each action builds evidence of control and capability.
Audit and agree
Run audits, close actions and put clear quality responsibilities in writing.
Monitor
Track performance, handle changes and requalify when needed.
FAQ
Common questions
Do you audit offshore suppliers?
Yes. We perform remote or on site audits and manage time zones and language needs with clear agendas and evidence requests.
Can you work with our ERP or QMS tools?
Yes. We map supplier data and records to your systems and create clean links for auditors.
What if a supplier has many findings?
We prioritize actions, coach CAPA and recheck effectiveness so risk and compliance improve quickly.
How often should we reassess suppliers?
At least annually for higher risk categories or when changes, issues or trends indicate.
Ready to strengthen your supply chain?
Book a quick call to align audit scope, agreements and metrics so suppliers support approvals and scale.