Want to be sure your QMS is truly effective and compliant?
Internal audits are the key tool to verify performance, anticipate potential issues, and improve business processes.
Clariscience supports Life Science companies with a comprehensive internal audit service, carried out by qualified, independent auditors with proven expertise in medical devices and IVD. Our goal is to assess the effectiveness, efficiency, and compliance of your Quality Management System (QMS) against applicable standards (ISO 13485, ISO 9001, MDR, IVDR), providing an objective and constructive perspective.
Why conduct an internal audit?
Internal audits are not just a regulatory requirement (ISO 13485 / ISO 9001)—they are a strategic choice to maintain process control, prevent non-conformities, strengthen your quality culture, and prepare effectively for certification audits (system and product).
Why outsource internal audit?
Partnering with an external qualified auditor means gaining an objective, independent analysis based on real-world experience in the medical and IVD sectors.
Many companies choose to outsource because it allows them to:
- Ensure impartial evaluation of the QMS
- Gain an external perspective to prevent issues and highlight strengths
- Receive actionable improvement insights based on best practices
- Access specialized expertise that is hard to maintain internally
- Optimize time and resources, especially during critical phases like certification preparation
- Train staff through direct interaction with experienced auditors
Outsourcing your audit means choosing informed control—a fresh perspective that anticipates risks and enhances what works.
Our service
Shared planning
We define objectives, scope, and audit criteria together and prepare a tailored audit plan aligned with your business needs.On-site assessment
Our auditor visits your site(s), reviews documentation, interviews staff and collects objective evidence.Open communication
Throughout the audit, we share observations and suggestions with your team and management, ensuring a constructive dialogue focused on identifying issues and finding solutions.Detailed report & post-audit support
Receive a comprehensive report with any deviations and improvement proposals. Our auditor remains available for clarifications even after the visit.
Why choose Clariscience
Outsourcing your audit is not about delegating—it’s about strengthening your control.
Our service provides a clear, objective snapshot of your QMS, enriched by constructive feedback from expert auditors, tailored improvement insights, greater internal awareness, and ongoing support beyond the audit.
Is your Quality Management System truly ready?
Request a personalized proposal now: info@clariscience.com
