Loading ...

Lead and Internal Auditor Training

More than 130,000 auditors (and counting!) have relied on Oriel STAT A MATRIX for auditor training for ISO 9001, ISO 13485, MDSAP, EU MDR, and more.

How We Help

Gain the confidence to run effective audits in our popular ISO 13485 lead and internal auditor training classes, our Internal Auditing to MDSAP class, and our EU MDR auditor training class.  These courses consistently earn high marks (an average of 6.7 out of 7) because they are is interactive and yield a solid understanding of the relevant standard and/or requirements, every audit phase, and how to implement the standard within an organization.

Which Auditor Course Is Right for You?

Our ISO 13845 lead auditor class prepares you to conduct and lead quality management system (QMS) audits for medical devices through simulations, exercises, and workshops. Our approach teaches the audit discipline in accordance with ISO 19011 while providing a sector-focused learning experience for those engaged in the medical device industry.  This course is certified by Exemplar Global and satisfies the training requirements for individuals pursuing certification as QMS Lead Auditors. 

Our ISO 13485 internal auditor class prepares you to develop, implement, and perform internal audits of a quality system that efficiently and effectively meets the requirements of ISO 13485 and ISO 9001. This course is certified by Exemplar Global.

If you need to learn how to perform internal and supplier audits to the EU Medical Device Regulations, then choose from our EU MDR Auditor or EU IVDR Auditor training classes.

Designed for experienced auditors, our Internal Auditing to MDSAP class will teach you how to apply MDASP's process-based audit approach and align your current internal audit program to the MDSAP requirements. If you pass the final exam, you'll earn an Exemplar Global certification for QM-MDSAP Competency demonstrating knowledge and ability to conduct MDSAP audits.

Public and Private Training Options

Our ISO 13485 lead auditor training – as well as our other auditing classes – are offered frequently in 12 cities across the US and Costa Rica, or a virtual instrucor-led trainings. All of our classes can also be delivered as private programs tailored specifically for your company. Private training tends to be a more cost-effective alternative for groups of six or more.

Materials Licensing

Oriel STAT A MATRIX’s training materials provide the foundation for the performance improvement and regulatory compliance training programs of scores of organizations – including many Fortune 500 companies. We offer comprehensive support tools (including detailed instructor guides) to ensure a consistent training experience throughout the organization.

Exemplar Global Certified

Exemplar Global certification demonstrates a level of rigor and industry-recognized quality for the course. Oriel STAT A MATRIX is a Exemplar Global Registered Training Provider. Our auditor courses provide the necessary body of knowledge for individuals to pursue Exemplar Global certification under the “qualification-based” or “competency-based” auditor schemes. 

Contact us for a personal training needs assessment.

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
Inspection and Audit Readiness Training for Medical Device Manufacturers
Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality

Learn how to effectively set up a front room/back room audit approach so you are ready for FDA and NB audits/inspections.

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

REQUEST A PROPOSAL Or ask a question!
Get answers right now. Call
us flag

US OfficeWashington DC


EU OfficeCork, Ireland

eu flag

+353 21 212 8530

© Oriel STAT A MATRIX. All Rights Reserved. Site Map Privacy and Legal