ISO 13485 Internal Auditor Training is for anyone that wants to be part of the team that performs internal audits of part of their Quality Management System (QMS) based on ISO 13485.
Why Comply Guru?
- CQI & IRCA Certified Training
- Industry-leading Blended Methodology
- Delivered by Experts with Proven Expertise
- Less Fixed Classroom Time
- Learn Online from Home or Work
Key Course Information
What you need to know?
Our 16hr ISO 13485 Internal Auditor Training course is a blend of 6hrs of highly interactive eLearning theory modules that are completed first before attending 1-day (in-person delivery) or 2 half days (virtual delivery) 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, 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
- Management System 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
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 Workshop as 100% attendance is required
- Obtain 70% or higher in the graded assessments during the Instructor Workshops
CQI & IRCA certify this course (No. 2286). Upon successful completion, each Learner shall receive a digital Certificate of Achievement within 1 business day.
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 Internationally Accredited Qualification as an ISO 13485 Internal Auditor
Advance your knowledge and enjoy more convenience & flexibility with blended learning.
Frequently Asked Questions
Reviews & Ratings
260 global ratings
I liked that the first module was in depth about the ISO13485 standard.
A very informative and well presented training course. Highly recommended
Very enjoyable, interactive course. Group exercises good fun.
This course was my first with Comply guru,and i will try to not make it my last.I think it would be of benefit to our company if we could work together with Comply guru to supply more training courses for our employees at all levels,as this would help to build our knowledge,education and confidence in auditing situations,not only dealing with internal audits,but also dealing with outside agencies.
very professional, overall good experience
Instructor, John Collins, Cant fault new his subject matter, very well, his manner and communication skill are top notch. The only negative for me, being old school was not being in a class room face to face, found it hard to interact with all present, that old dog and new tricks thing. But saying that overall found it to be excellent.
I really enjoyed the course, john came across very knowledgeable and approachable which made it a very pleasant and valuable experience!
I really enjoyed the course. The content was as expected and John was great, made me feel relaxed from the outset and I had confidence in what I was doing throughout. I have learned a lot and am looking forwarded to putting it into practice in the workplace. Thanks
THIS IS MY SECOND COURSE TO COMPLETE WITH COMPLY GURU, AND MY FIRST WHICH INCLUDED A VIRTUAL WORKSHOP. THE ELEARNING IS VERY ENJOYABLE, BEING ABLE TO COMPLETE IT AT MY OWN PACE. AND THE KNOWLEDGE CHECKS AND SCENARIO BASED EXERCISES KEEP ME UP TO SPEED.
The content was always clear but the questions in the first assessment some times tricky which is understandable but I would've like to see my wrong answers.