ISO 13485 Internal Auditor Training is for anyone that wants to be part of the team that conducts internal audits of part of their Quality Management System (QMS) based on ISO 13485.
Why Comply Guru?
- CQI & IRCA Certified Training (No. 2286)
- Industry-leading Blended Methodology
- Delivered by Experts with Proven Expertise
- More Convenient, Flexible & Effective Format
- Virtual & In-Person Workshops Available
ISO 13485 Internal Auditor Training
Our Blended Learning Methodology is a hybrid of 6hrs of highly interactive eLearning theory modules that are completed first before attending 1-day (in-person) or 2 half days (virtual) of skills-based Live Instructor Workshops that focus on practical application in a real life context.
Face to Face Learning
On completion of this course, successful Learners will have the knowledge needed to:
- Explain the purpose of a medical device quality management system (MD QMS), of medical device quality management systems standards, and the business benefits of improved performance given by an effectively implemented medical device quality management system
- Outline the structure and content of ISO 13485 and its relationship with ISO 9001 and IMDRF individual country regulatory documents
- Explain the specific quality management-related requirements of ISO 13485
- With reference to the PDCA cycle, explain the process-based QMS Model for ISO 13485 and the role of an internal auditor in the maintenance and improvement of Quality Management Systems
- Explain the role and responsibilities of an auditor to plan, conduct, report, and follow up an internal audit in accordance with ISO 19011
A summary of learning topics within this course include:
- Purpose, Benefits & Structure of ISO 13485
- Quality Management Principles
- Terms & Definitions
- Documentation Requirements
- Plan-Do-Check-Act (PDCA)
- Process-based Quality Management Systems
- Risk Based Thinking (RBT)
- Management Commitment
- ISO 13485 Audits
- Audit Terminology
- Principles of Auditing
- Audit Program Management
- Certification Audit Program
- Audit Life Cycle
- Audit Scope, Objectives & Criteria
- Selection of Audit Location
- Selection of Audit Team
- Auditee, Observer & Guides
- Audit Initiation & Preparation
- The Audit Plan
- Audit Documentation
CQI & IRCA certify this course (No. 2286). Upon successful completion, each Learner shall receive a digital Certificate of Achievement within 1 business day.
Before completing this course, each Learner should have the following prior knowledge:
- It is recommended that anyone wishing to attend this course has some work-based experience in Quality Management (based on ISO 13485)
- The Plan, Do Check, Act (PDCA) Cycle
- The core elements of a management system and the interrelationship between top management responsibility, policy, objectives, planning, implementation, measurement, review, and continual improvement.
Fluency in written and spoken English
- For participants whose first language is not English, we recommend a minimum English language competency of IELTS 5.5 (or equivalent) for successful completion of the program. This is not assessed by Comply Guru in advance & each participant must self-assess their competency.
Copy of ISO 13485 (International Standard)
- It is recommended that each Learner should have a copy of ISO 13485:2016 (International Standard) to reference while completing this course. This is not provided by Comply Guru and without it, this course will be challenging to complete successfully.
In order to successfully complete this course, each Learner will need to:
- Complete the eLearning modules and obtain 70% or higher in the final assessments (MCQ-based) by the required deadline set in advance of the given workshop dates you are registered for
- Fully attend the Instructor Workshops as 100% attendance is required
- Obtain 70% or higher in the graded assessments during the Instructor Workshops
For the live workshops during a virtual delivery, we utilise both Zoom and Microsoft Teams.
Learners need to individually have:
- PC or MAC Computer
- Reliable Internet
- Video Webcam
- Headset or Earbuds
- Quiet Setting
In relation to the eLearning Modules, in our experience, Workplace IT environments’ internal configurations and available software can vary (new or old), and there may be various limitations or other restrictions in place, and as such, the functionality of any Learning Management System (LMS) may be impacted, restricted and may not perform well. Read the full technology requirements here.
Pricing & Schedule
Gain an Accredited ISO 13485 Internal Auditor Qualification
Advance your knowledge and enjoy more flexibility & learning effectiveness with blended learning.
Skillnet Discount Eligible
Employed persons in Ireland are eligible for funding supports offered by Irish Medtech Skillnet. Contact us for details.
Discounted Price: €331 per person
Skillnet Discount Enquiry
Book 3 + Get 1 FREE
Save up to
Why Choose Comply Guru
About Our ISO 13485 Internal Auditor Training
Learn about how our IRCA Accredited ISO 13485 Internal Auditor Training is leading the industry for innovation & learning effectiveness
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
270 global ratings
Extremely professional training - the self paced learning was interactive and you can easily go back and forth with all the content. John the Tutor was a wealth of knowledge and experience, was engaging, entertaining and inspirational. Highly recommended!
Great course, informative and interactive with a good tutor and course criteria. Was fun and engaging.
Overall, I've had a very positive experience. John was great with leading the workshops and was very knowledgeable. I think his experience is invaluable and I don't think I've ever had a course with someone that has built such a good rapport with his class. Very interactive and the self-paced modules were a good segue into understanding the theory and preparing you for the workshops.
I thoroughly enjoyed this training course. The content was pitched at the perfect level for my current situation - I learned a lot, but I also wasn't too out of my depth! John is an excellent trainer, very easy to listen to, very engaging and knowledgeable.
John was engaging, very knowledge and made the course interesting and very much an enjoyable experience.
Frequently Asked Questions