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Course Fee

USD $1,450.00

Early Bird Price*

USD $1,350.00

This virtual course is designed for maximum flexibility, allowing students to learn from anywhere while maintaining the same level of engagement and effectiveness as an in-person class. Our interactive approach ensures a dynamic and immersive learning experience.

* Enrollment must be completed at least 30 days prior to the course date.

Course Highlights & Objectives

  • Thorough review and understanding of the various types of interpretations related to ISO 13485:2016 as well as the purpose of the ISO 13485 series
  • Understand the roles, responsibilities, and value that an auditor brings to an organization
  • Conduct full cycle internal audits both onsite and in a remote fashion
  • Learn from experienced auditors on how to audit effectively and efficiently

Course Details

This 3-day remote course is taught by experienced instructors who are currently working in the development, implementation and auditing of Quality Management Systems (QMSs) throughout the world. This course will include a processed-based approach with instruction on a QMS and internal auditor training. The emphasis will be on the following and will better prepare you for your own internal audits regardless of whether you have an eQMS or a solely paper-based system in place: 

  • Understanding and interpreting the requirements of ISO 13485:2016
  • Auditing techniques including preparation:
    • Planning 
    • Opening 
    • Interviewing 
    • Closing 
    • Reporting

Attendees who successfully pass the continual assessment of this course will receive a Certificate of Attainment.

Course Expectations

The course includes exercises, group-work, role-playing and a mock audit to test the theoretical skills learned during the course. The result: an interactive learning environment designed to help you take on your own internal audits and manage your ISO 13485:2016 system. Your Internal Auditor Training will cover:

  • Mandatory prerequisite requirements for the course are fulfilled by preparation materials covering understanding of the content, application and implementation ISO 13485:2016
  • Understanding and interpreting the requirements of ISO 13485:2016
  • The system-process model and the process-approach of the ISO 13485:2016 standard
  • Fundamental principles of Quality Management Systems
  • Introduction to audit system requirements 
  • Role of audits within a quality management system including implementing an audit system, planning and controlling audits, and getting value from audits
  • Effective and efficient auditing techniques, include developing and using audit checklists
  • How to generate meaningful, well-written audit and nonconformance reports

Course Materials

Students will receive logistical and planning communication from their instructor on how to access electronic course material prior to the start of the class.  Course material will include a Course Manual, Pre-Course Exercises, Student Handbook, and a Continual Assessment handbook.  These will be available to the students to view, print and download.  Please note that a copy of the ISO 13485:2016 standard is not included and students are required to have a copy for their use in this course.  

Course Requirements

  • Hardware: A desktop or laptop computer is recommended for the best experience.  Devices should have up-to-date operating systems and web browsers to ensure compatibility with the online training platform.  Headsets, webcams, speakers and microphones are necessary for clear audio/video communication. 
  • Software: students are required to receive emails in order to communicate directly with Cavendish Scott and the tutor on pre-course and course materials.  Students are also required to have a web browser that can join Microsoft Teams or Zoom meetings
  • Connectivity: students are required to have a stable and minimum internet download speeds of 1-2 Mbps and an upload speed of at least 0.5 Mbps.  Learners and tutors should have a backup plan in case of internet outages.
This was by far the best auditing class I’ve attended and should we need more students trained, Cavendish Scott will be our choice for trainers. The interaction and exercises were phenomenal and the fact that we got audits completed that we can count towards our yearly schedule was a definite plus.
Aerospace Services Organization Corporate Director Product Assurance
The [lead] auditor class was absolutely one of the best I’ve ever had the pleasure of attending and know Cavendish will be invaluable in the [ISO] process.
Metal Processing and Manufacturing OrganizationQuality Manager
It would have been a difficult course for most of us if it weren't for your patience and teaching skill. You have made us all better stewards of the taxpayer's money by making us proficient auditors.
Naval ShipyardQuality Assurance
This course gave me an excellent overview of the ISO 9001 standard and I now have an appreciation for and solid knowledge of the standard, its intent, and how to audit against it.
Chemical Test Standards LaboratoryDocumentation Coordinator & Auditor
This is actually the best class I have attended. Instructor was amazing and very knowledgeable.
Integrated Circuit Design and Manufacturing CompanyTop Manager
I had no previous knowledge of the auditing process prior to the course. I now feel much more confident in my understanding of the audit process and ability to perform internal audits.
David A.
I loved the exercises! They were very effective practice tools for practicing skills needed to conduct audits. The live audits were also a great way to introduce us to the process of conducting an audit without the pressure of doing it on our own. Since it took place during the training and we had an instructor to guide us, doing our first audit was quite easy!
Celina D.
This course took me from little to no familiarity with ISO 9001:2015 to walking away feeling like I had a very good grasp on the standard and the process to audit against it.
Anonymous
The training was very thorough and our trainer was very knowledgeable and passionate. Makes learning very motivating.
Myia M.
The trainer was incredible. She made the course a blast to participate in. Knowledgeable and extremely personable. After taking the course am interested in continuing my knowledge gathering about audits.
Joshua B.
I liked the way the trainer broke down the standard into smaller bite sized portions that made it so much easier to understand. AS9100 is not the big monster anymore.
Ted M.
We found the training very informative and beneficial! The trainer did a beautiful job in making the class enjoyable and interactive. Her wealth of knowledge and experience added much substance to the class.
Anonymous
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