Quality System Audits for Medical Devices

A Structured, Real-World Audit Approach

RQMIS goes beyond checklist auditing.

Our process evaluates both compliance and operational effectiveness, ensuring your QMS works in practice—not just on paper.

Step 1: Desk Audit (Documentation Review)

We begin with a focused review of your quality system documentation to assess readiness and identify high-level gaps.

• Review of procedures, records, and system structure
• Alignment with applicable standards (ISO 13485, 21 CFR 820, EU MDR)
• Identification of missing or incomplete elements

Step 2: On-Site / Operational Audit

We conduct a detailed, multi-day audit to evaluate how your system performs in real-world conditions.

• Review of quality records and processes
• Verification that procedures are being followed
• Assessment of operational effectiveness and consistency

This includes ensuring alignment between documented processes and actual execution.

Step 3: Findings & Action Plan

At the conclusion of the audit, we provide clear, actionable insights.

• Identification of major and minor nonconformities
• Practical recommendations for remediation
• Final report and management discussion outlining strengths and weaknesses

What We Deliver

• Internal Audits: We conduct scheduled internal audits to maintain ongoing compliance and readiness.
• Supplier Audits: We evaluate your suppliers to ensure they meet quality and regulatory requirements.
• Compliance & Gap Analysis Audits: We assess your system against specific standards and identify gap
  • ISO 13485
  • MDSAP
  • FDA QSR / QMSR (21 CFR 820)
  • EU MDR (2017/745)
  • Other global regulations
• Pre-Certification & Inspection Readiness: We prepare your organization for high-stakes audits.
  
  • Notified Body certification audits
    
  • FDA inspections
    
  • Customer audits
    
• Audit Program Management & Training: We don’t just audit—we help you sustain compliance.
  
  • Full internal audit program management
    
  • Training your team to conduct effective audits
    
  • Building long-term audit capability within your organization
    
• Regulatory Audit Representation: When audits happen, we stand with you.
  
  • FDA inspection support
    
  • Notified Body audit support
    
  • Customer and third-party audit representation

More Than Compliance—A Tool for Improvement

Quality audits aren’t just about finding problems—they’re about improving performance.

A well-executed audit program helps you:

• Strengthen processes and reduce inefficiencies
• Improve product quality and consistency
• Reduce risk of costly quality events
• Build confidence with regulators and partners

The Outcome

With RQMIS, you can:

• Identify and resolve compliance gaps early
• Prepare for audits with confidence
• Reduce risk of FDA findings and delays
• Build a stronger, more effective QMS
• Maintain continuous compliance across global markets

Stay Ready—Not Reactive

The companies that succeed aren’t the ones who pass audits—they’re the ones who are always ready for them.