Internal auditing
Independent internal audits against ISO 13485, ISO 9001, EU MDR, IVDR, UK MDR and relevant company procedures, including focused process audits and complete audit reporting.
Internal & external auditing
Independent audits with practical follow-through.
Focused process reviews, full-system audits, supplier assessments and external audit support across medical-device and wider quality standards.
Clear findings. Effective corrective action.
RHQC provides objective assessment against applicable standards, regulations and internal procedures, with findings explained clearly and supported by proportionate recommendations.
Support can continue through root-cause analysis, CAPA implementation and effectiveness review—helping organisations turn audit outcomes into lasting system improvements.
Supplier & external auditing
Risk-based qualification and external audits of manufacturers, critical suppliers, sterilisation providers, warehouses, distributors and outsourced processes.
Certification readiness audits
Full-system gap assessments and pre-certification audits to identify weaknesses before certification-body, notified-body or regulatory-authority assessment.
Audit hosting & support
Preparation of evidence, staff readiness, participation during external audits and clear coordination of responses through certification and surveillance activity.
CAPA & nonconformity remediation
Root-cause investigation, corrections, corrective actions, effectiveness review and structured remediation of audit or technical-documentation findings.
Supplier quality management
Supplier classification, approval, monitoring, quality agreements, performance review and proportionate controls for outsourced products and processes.
Process & compliance audits
Targeted reviews covering document control, design and development, risk management, purchasing, traceability, complaints, PMS, vigilance and other critical processes.
Ongoing audit programmes
Risk-based annual audit schedules, independent execution, follow-up and management reporting as part of a retained quality-support arrangement.
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