ISO 13485 Resources for Medical Device Quality Management

This certificate confirms successful completion of the Auditor Skills 101 course. It provides formal recognition of the knowledge and skills gained during the training and can be used to demonstrate your learning achievement to employers, clients, or professional networks.

From Student to Instructor: Build the skills to train with confidence.

Our Train the Trainer program equips certified auditors with the skills, tools, and confidence to deliver effective training programs of their own. This 24-hour, remote 1-on-1 experience blends structured learning with real-world practice, ensuring participants not only understand adult learning principles but also know how to apply them in dynamic training environments.

Program Requirements

• Must hold an auditor certificate in good standing

• Commitment to completing 16 hours of guided 1-on-1 instruction and 8 hours of live event shadowing

Learning Tracks & Modules

1. Overview, General Concepts & Administration – Establish the foundation of training best practices.

2. Course Planning, Design & Development – Learn to structure impactful and engaging training courses.

3. Leveraging Existing Resources – Maximize available materials for efficiency and effectiveness.

4. Effective Communication & Presentation Skills – Develop clear, confident, and engaging delivery techniques.

5. Evaluation & Assessment – Measure learning outcomes and continuously refine your approach.

6. Active Learning & Demonstration – Create interactive experiences that deepen retention.

7. Continuous Improvement – Build a habit of reflection and iteration for long-term success.

Program Format

• 16 hours of personalized remote training sessions

• 8 hours of shadowing a live training event

• 24 total hours of immersive learning

By the end of the program, participants will be prepared to confidently design, deliver, and evaluate their own training courses, empowering them to lead with credibility and impact.

Unlock Your Business's Hidden Gaps: Get a Custom Roadmap to Streamline Operations in Just 60 Minutes

Tired of fragmented processes, compliance headaches, and goals that never quite land? Our Gap Analysis Workshop reveals exactly where your management system is falling short—and hands you a personalized plan to fix it. Based on ISO 9001 best practices, it's the quick win your team needs.

Book Your Workshop Now for $350

OR FREE with our Premium Subscription to the Concentric Community

We offer several test-out options for students interested in Exemplar Global Certification and meet competency pre-requisites. Quick, simple, and cost-effective!

Pre-requisites:

1. You must successfully completed an auditor training course for the respective standard/subject matter you are seeking Exemplar Global Certification for.

2. The hours of the course(s) completed must be greater than or equal to 24 hours of course work for Auditor or 32 hours for Lead Auditor.

3. Your current qualifications through training, education and experience provide the skills necessary to complete effective internal and/or supplier audits.

4. You must be able to provide evidence of training records issued by the training provider (i.e. Certificate of Training, test results, etc.) including the certificate #, expiration date (where applicable) and training provider used for your initial training.

Build a bulletproof management system.

Don't build your system on a shaky foundation. This architectural framework provides the 12 essential tools needed to structure a robust, scalable, and compliant management system from the ground up.

"Everyone hears only what he understands." - Johann Wolfgang von Goethe

12-Tools for Mastering the Processes You Manage

The 12-Tool Management System Architecture is a toolbox made of benchmarks for compliance and beyond. These tools and management system structure has been deployed throughout the world to take market leaders in automotive, aerospace and various other sectors to the next level. With understanding and structure comes organizational excellence. This organization model provides the framework for mastering the processes you manage. Learn more by watching the free 1-hour webinar below and begin your journey to the next level.

Stop struggling with process maps.

Visualizing your processes shouldn't take days. This all-in-one bundle gives you every template, example, and guide you need to create "Turtle Diagrams" that auditors love. Define inputs, outputs, and metrics instantly.

Outcome: A fully mapped, audit-ready system in a fraction of the time.

Streamline your workflow with our most comprehensive process optimization package yet. Ready to run powerful process optimization workshops and have your tools prepped and ready to go? We’ve bundled our popular Turtle Diagram Masterclass with our Editable Template + 18 Pre-Filled Turtle Diagrams to give you everything you need to facilitate, teach, and implement process improvements—fast. The Ultimate Turtle Diagram Bundle combines training, templates, real-world examples, and visual aids to help you lead effective process improvement sessions with confidence and clarity.

What You’ll Get:

• Turtle Diagram Masterclass (90 minutes)

  Learn how to confidently facilitate your own workshop, transfer process ownership, reduce risk, and improve team communication using the Turtle Diagram approach.

• Editable Turtle Diagram Template

  Make it your own and build consistent, repeatable process maps.

• 18 Pre-Filled Turtle Diagrams

  Plug-and-play examples across common workflows—because you’ve got better things to do than start from scratch.

• Presentation + Workshop Decks

  Wow your team (or clients) with professional, ready-to-use slide decks that support your session.

• 2 Print-Ready Posters

  Get everyone on the same track with two 36x48" print-ready posters that can be printed out and used in team areas. This useful tool has one side with a blank Turtle Diagram for interactive use and the other a pre-filled example to spark ideas and clarity.