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.