Online ISO 13485 Internal Auditor Training | CQI & IRCA Certified
Online ISO 13485 Internal Auditor Training (CQI & IRCA Certified) for anyone that wants to gain an internationally recognized qualification to be part of the team that performs internal audits of part of their Quality Management System (QMS) based on ISO 13485 and it can be attended from anywhere in the world.
Why Choose Blended ISO 13485 Internal Auditor Training?
Learners start by completing eLearning modules on the underlying principles & the theory of Quality Management and ISO 13485 Internal Auditing which provides better preparation in advance of shorter, more focused instructor workshops on the practical skills for 1st party auditing.
Course Format & Content Breakdown
This ISO 13485 Internal Auditor Training course is split into a blend of 6hrs of eLearning that is completed first before attending 1 in-person day or 2 virtual days of skills-based Instructor Workshops.
It is important to note that the exact time it takes to complete the eLearning modules will vary based on current knowledge, experience, and learning style.
During the eLearning modules, each Learner will cover the following theory & knowledge:
- 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
Instructor Workshop Modules
During the instructor workshops, the focus is on skills & application of the theory for:
- Document Review
- Development of the Audit Plan & Checklist
- Opening Meeting
- Simulated Audit Exercises
- Audit Findings
- Audit Conclusion
- Closing Meeting
- Audit Reporting
- Audit Follow Up
On completion of this Online ISO 13485 Internal Auditor Training, 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
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.
ISO 13485 Requirements
- Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions
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.
Assessment & Certification
ISO 13485 Internal Auditor Training Assessment Methodology
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
ISO 13485 Internal Auditor Training Certification
CQI & IRCA accreditation is offered with our Blended Internal QMS Auditor based on ISO 13485 Training Course (No. 2286). Successful completion will entitle each Learner to receive a digital Certificate of Achievement.
There are recommended requirements for each Learner in wishing to complete any of our 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 full technology requirements
Terms & Conditions
In registering for this course, each Learner and/or Customer expressly acknowledges that they have read, fully understood and agreed to be bound by all of Comply Guru’s terms & conditions, including additional licensing agreement. The terms & conditions & licensing agreement can be read here.
- Subject Area
- 16 Hours
€ 595.00 per person
- Blended Learning A hybrid of eLearning & Instructor Workshops
- CQI & IRCA (No. 2286)
- Delivery Mode
- Available Classroom, Virtual, Public or In-Company
- Explainer Video
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Reviews & Ratings
182 global ratings
Excellent course, will highly recommend to other employees inside and outside of our company. I have a proper understanding of Internal auditing and a new found respect for auditors and the amount of work that goes into it!!
I think the self paced modules were very long, yet may have been necessary to gain the knowledge for the live portion of the course
Very enjoyable course, the self paced learning before worked well. John was very positive and energetic making the instructor lead course more interactive. The only recommendations are from the two points above.
It was an amazing experience.
Overall , the course was very effective in the way is was demonstrated in the coursework and in the workshops. It gave a greater understanding of the course material.
Felt the instructor was very good. Used real world examples which I could link back to thing I had seen at various times throughout my career so far and how to deal with them. The interactive parts and team exercises were very good as we could discuss with people from various backgrounds to get different perspectives
Course was very good, instructor was good at getting people to participate and simulate an actual audit environment
As a process engineer the experience gained will aid my future development within the industry
This is a really worthwhile and enjoyable course. Our instructor was very knowledgeable on all aspects of the ISO 13485:2016 Standard and related all learning objectives back to real life examples which I found really beneficial. I would definitely recommend this course.
Had a great experience completing the internal audit training with John. He was very knowledgeable and helped with any questions we had. He made me feel at ease as i was quite nervous before starting this course as i didnt have that much audit experience and i didnt want to slow the training down. All these concerns and worries faded away once we started the training.