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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, and other standards.

Gain the confidence to run effective audits in our popular ISO 13485 lead and internal auditor training classes  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, 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.

We also offer auditor training for ISO 9001:2015.

Public and On-Site Training Options

Our ISO 13485 lead auditor training classes – 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
ISO 13485 Internal Auditor Training
Risk Management for ISO 9001:2015
Transition to ISO 13485:2016
New!   Transition to the Medical Device Single Audit Program (MDSAP)
Transition to ISO 9001:2015
New!   Performance-Based Auditing for Medical Devices
A Tool for FDA’s Case for Quality
ISO 9001 Lead Auditor Training
ISO 9001 Internal Auditor Training

Now updated for ISO 13845:2016!  This interactive course gives you the relevant skills and knowledge you need to audit quality management systems for medical devices (QMS). Exercises include audit criteria from ISO 13485:2016. Click to learn more.

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.

Based on ISO 31000:2009, Risk management – Principles and guidelines, this course provides a framework for managing risk regardless of the size of the organization, its context, or its industry sector. Click to learn more.

 

This course was developed by a leading member of the ISO TC/210 working group responsible for creating ISO 13485:2016. Learn key changes and how they impact your organization.

Is your company participating or considering participation in MDSAP? Our 2-day course will help you understand the program and plan a transition to MDSAP. Click to learn more.

In this course, we discuss the major changes that were introduced in the new standard, and address how organizations should consider these changes as opportunities to make their quality management system a strategic element of good performance and sustainability over time. 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.

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.

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.

Provided below are a variety of practice related white papers, market updates and case studies.

Updated! The New ISO 13485: Major Changes Your Organization Must Address

Increasing the Value of Audit Programs with Performance Based Auditing

Our team is here to help. Call 1.888.532.6360 or contact us online ›