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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.

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 – all of which have been updated to use ISO 13485:2016 criteria. 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.

Designed for experienced auditors, our Internal Auditing to MDSAP class is the only MDSAP auditing class that can help you earn an Exemplar Global certification for QM-MDSAP Competency demonstrating knowledge and ability to conduct MDSAP audits.

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.

We also offer auditor training for ISO 9001:2015.

Public and On-Site 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. All of our classes can also be delivered as private, on-site training programs tailored specifically for your company. On-site training tends to be a more cost-effective alternative for groups of five 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’s Exemplar Global Certified 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.

Select a course below to learn more or to register.
Course Name Public On-site
ISO 13485 Lead Auditor Training
EU MDR Auditor Training (Europe’s Medical Device Regulation 2017/745)
ISO 9001 Lead Auditor Training
New!   EU IVDR Auditor Training (Europe’s In Vitro Diagnostic Regulation 2017/746)
ISO 13485 Internal Auditor Training
ISO 9001 Internal Auditor Training
Internal Auditing to MDSAP: Concepts and Practices in Aligning the Internal Audit Program
Medical Device Single Audit Program (MDSAP) Training: Preparing for a Successful Transition
Performance-Based Auditing for Medical Devices - A Tool for FDA’s Case for Quality

Learn the relevant skills and knowledge you need to audit quality management systems for medical devices (QMS). Click to learn more.

Designed for experienced auditors who need to perform internal and supplier audits to the EU MDR requirements. Click to learn more.

Our ISO 9001 Exemplar Global-certified auditor/lead auditor training course, presented largely through hands-on workshops, teaches you the skills you need to plan, conduct, and follow-up on ISO 9001 compliance audits. Click to learn more.

For experienced auditors who need to perform internal and supplier audits to the EU IVDR requirements.

Exemplar Global Certified QMS Internal Auditor Training Course. Learn the steps to develop, implement, and audit an internal quality system that efficiently and effectively meets the requirements of ISO 13485 and ISO 9001. Course exercises feature audit criteria from ISO 13485:2016. Click to learn more.

Understand the steps in developing, implementing, and auditing an internal quality system that meets the requirements of ISO 9001 and the needs of your organization. Click to learn more.

Designed for experienced auditors, this intensive class will teach you how to apply MDASP's process-based audit approach and align your current internal audit program to the MDSAP requirements. Click to learn more.

Unique to MDSAP audits are a process-based audit approach and use of a nonconformity grading matrix. Understanding these two critical components of MDSAP is key to a successful certification audit, and this course covers both in depth. Click to learn more.

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.

Increasing the Value of Audit Programs with Performance Based Auditing

Becoming an Effective ISO 13485:2016 Auditor 101

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