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 (No. 2286)
- Industry-leading Blended Methodology
- Delivered by Experts with Proven Expertise
- Less Fixed Classroom Time
- Learn Online from Home or Work
ISO 13485 Internal Auditor Training
Our industry-leading Blended Learning Methodology is a hybrid 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
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 Workshop 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.
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About Our ISO 13485 Internal Auditor Training
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What Our Learners Are Saying
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262 global ratings
I really enjoyed this course much more than I expected. The trained allowed it to be very engaging and promoted learning through
The Training experience was good
My experience with the courses at Comply Guru has been excellent. The content of the courses was well defined and informative. The self-paced format was extremely convenient and the virtual workshop provided a friendly platform to enhance the basic knowledge to practical knowledge. I truly recommend the courses at Comply Guru.
A very informative and well presented training course. Highly recommended
Very enjoyable, interactive course. Group exercises good fun.
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