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Performance-Based Auditing

See a positive ROI from your audit program by collecting the data your organization needs to improve performance and results. 



Traditional audits examine the conformance of processes against a set of requirements. Oriel STAT A MATRIX’s performance-based auditing training and consulting methodology uses a specific approach to audit preparation and audit execution to document the:

  • Effectiveness of the management system in achieving business results.
  • Efficiency of the management system processes toward achieving business results with the least amount of resources.

These types of findings quantify the costs of poorly performing processes, empowering you to speak the language of management: dollar and cents.

They also reflect FDA's increasing emphasis on performance-related data in the Case for Quality Initiative, which "[t]reats compliance as a baseline, giving greater emphasis to the FDA and stakeholders focusing on critical-to-quality practices that correlate to higher quality outcomes. The FDA is working with stakeholders to promote manufacturers' implementation of critical-to-quality practices in day-to-day device design and production."

Prepare for this shift in emphasis with expert assistance from Oriel STAT A MATRIX.

Our experienced auditors will work alongside your team to create a performance-based audit program by refining the existing vision for the audit program, audit methodology, audit criteria, and auditor skills.

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 achieve conformance to internationally recognized standards and regulations such as ISO 13485 and FDA’s QSR.

In addition to conducting audits and training auditors, we have a leading practice in Performance Excellence. By integrating tools from our performance excellence offerings, we bring a powerful methodology to auditors, thereby providing them with a more comprehensive skill set to apply to your organization’s audit program.

Training Courses

Classes are available as in-person or virtual instructor-led trainings. Select a course to learn more or to register.

Course Name Public Private
Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality

Designed for experienced auditors. Course participants learn how to go beyond compliance and analyze the performance-related data needed to improve processes, produce higher-quality devices, and achieve better patient outcomes.

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

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