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Supplier Quality System Audits

Supplier (second-party) audits for ISO 9001, FDA cGMP,  ISO 13485, and MDSAP.


How We Help

Build a strong supplier audit program with support from Oriel STAT A MATRIX.

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

It’s your responsibility to ensure that your subcontractors’ processes meet relevant standards and regulations. This is both good business and a requirement of the ISO 9000 series, FDA cGMP, and other standards and regulations.

The good news? You don’t have to do it alone. Our experienced auditors can help you verify that your suppliers are meeting relevant requirements.

Supplier audits from Oriel STAT A MATRIX:

  • Identify supplier strengths, weaknesses, nonconformities, and opportunities for improvement.
  • Ensure that suppliers consistently comply with the requirements specified in supplier agreements and relevant standards or regulations.
  • Increase efficiency and save money by addressing quality at the root (supplier) level and preventing problems from recurring.

Additionally, we can work with you to create a supplier development program that supports your suppliers’ corrective action and process improvement efforts.

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 130,000 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. 

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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