Expert Services

Supplier Audit Services

Supplier Audit Services by AQC

At AQC, we provide comprehensive supplier audit services to help medical device and in vitro diagnostic (IVD) manufacturers ensure their suppliers meet ISO 13485, MDR 2017/745, IVDR 2017/746, MDSAP, and FDA QSR (21 CFR Part 820) requirements. Our expert auditors assess supplier compliance, mitigate risks, and enhance supply chain reliability.

Why Supplier Audits Are Essential?

  • Regulatory Compliance – Ensure suppliers meet ISO 13485, MDR, IVDR, and FDA requirements
  • Quality Assurance – Verify suppliers maintain consistent product quality & process control
  • Risk Mitigation – Identify & resolve potential supply chain risks
  • Supplier Qualification & Monitoring – Evaluate new suppliers & ensure ongoing compliance
  • Improve Supply Chain Efficiency – Strengthen relationships with reliable, compliant partners

Our Supplier Audit Services

ISO 13485:2016 & EN ISO 13485:2021 Supplier Audits

  • Assess supplier compliance with QMS requirements
  • Review documentation, processes, & risk management practices
  • Identify non-conformities & recommend corrective actions

MDR 2017/745 & IVDR 2017/746 Supplier Audits

  • Ensure suppliers meet EU MDR/IVDR requirements
  • Assess materials, manufacturing, & post-market compliance
  • Conduct Technical Documentation & Quality Agreement reviews

FDA 21 CFR Part 820 (QSR) Supplier Audits

  • Verify compliance with US FDA Quality System Regulations (QSR)
  • Ensure Good Manufacturing Practices (GMP) are followed
  • Identify gaps & help suppliers meet FDA expectations

MDSAP (Medical Device Single Audit Program) Supplier Audits

  • Assess supplier compliance with MDSAP across multiple jurisdictions
  • Cover regulations in USA, Canada, EU, Australia, Brazil, & Japan
  • Conduct risk-based supplier evaluations & CAPA implementation

On-Site & Remote Supplier Audits

  • Perform on-site visits to manufacturing & supply facilities
  • Conduct remote audits for document & process verification
  • Provide detailed audit reports & compliance recommendations

Supplier Qualification & Performance Monitoring

  • Audit new suppliers for approval & onboarding
  • Conduct periodic assessments for ongoing compliance
  • Implement Corrective & Preventive Actions (CAPA) for non-compliant suppliers
Alpine Quality Consultants

Your Trusted Partner in Medical Devices & IVDs Technical Consultancy

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