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Internal Quality System Audits for ISO 13485, FDA QSR, MDSAP, EU MDR & IVDR

An Oriel STAT A MATRIX internal audit goes beyond the basics to give you higher-level advice for improving your quality management system (QMS) and business processes.


How We Help

Internal audits provided by Oriel STAT A MATRIX use a proven process to:

  • Verify conformance with the applicable standards and requirements.
  • Identify gaps between current activities and the requirements of the relevant standards and regulations.
  • Document areas where processes can be improved.
  • Devise any necessary corrective actions. 

This approach can be tailored to provide a complete review of your management system or to focus on specific areas. We can also manage of your organization’s internal audit program.

Need an audit done remotely? We can do that..

Additonal Audit Support

Oriel STAT A MATRIX provides public and onsite ISO 13485 lead and internal auditor training.  Public classes are offered frequently in 12 cities across the US and Costa Rica. Key course topics include Interpretation and use of ISO 13485:2016, the audit cycle and ISO 19011, preaudit activities,  auditing practices: the psychology of auditing, nonconformity reporting, process auditing, and follow-up and corrective action.  

Why Choose Oriel STAT A MATRIX?

Since 1968, organizations have relied on us for auditing services focused on management systems and regulatory compliance. Our global team of Lead Auditor Consultants average 25+ years of international and domestic life sciences industry experience. They have trained more than 100,000 auditors and have assisted hundreds of organizations regulated by FDA and global regulatory agencies to achieve conformance to internationally recognized standards and regulations such as ISO 13485 and FDA’s QSR.

We believe auditing is a powerful tool for ensuring ongoing compliance with relevant standards and requirements, identifying opportunities to improve management systems, and verifying that the resulting improvements are sustained over time.

See how we helped one multinational device company get its facilities ready for MDR.

Key Advantage 

Oriel STAT A MATRIX is a consulting company, not a certification or regulatory body, so our consultants can provide advice on how to remedy nonconformances.

Provided below are a variety of practice related white papers, market updates and case studies.

Oriel STAT A MATRIX’s Goal

Help our life science customers meet regulatory requirements, boost efficiency, and improve patient outcomes

Get answers right now. Call
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US OfficeWashington DC


EU OfficeCork, Ireland

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+353 21 212 8530

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