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: Work Experience
- 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
- Share Course
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Reviews & Ratings
218 global ratings
Excellent content, Expert tutors are the asset of Comply Guru.
Nice course format, small classes, good discussions in relation to ISO 13485.
It was an enjoyable training course and everyone was at ease from the beginning, however I would have liked to spend more time on the conducting the audit piece, reviewing the documents and capturing the correct clauses for findings. The instructor was very well experienced on the standard so it would have been more beneficial to have spent more time on that section. I don't think we needed as much time on how to conduct an opening and closing meeting, and more weight on how to connect findings to the correct clauses of the standard.
Fantastic Internal Auditor course, very impressed with experience level of our instructor John and will be back for the lead auditor course!
John lead a very interesting and interactive training course. His extensive experience and knowledge of the internal audit process made this training very easy to follow and learn from. John ensured that every member of the training felt included & had a great personal attitude towards the course in getting to know everyone first and ensuring we understood what the purpose of the course was & very encouraging when going through the outcomes of the exercises we carried out, always giving credit where needed & providing his knowledge ensuring to explain what the best answers were and why.
Very friendly and knowledgeable instructors. Any technical issues were solved very quickly
My overall training experience with Comply Guru was exceptional. I really enjoyed the blended learning approach. I thought it was well-planned and structured and it was easy for me to follow. The workload was just enough to finish everything with enough time, learn about the topics, and not feel overloaded and rushed. I would recommend Comply Guru to anyone wishing to further their knowledge of internal audits for ISO 13485.
Overall experience was great, John made the atmosphere relaxed and easy, and I learned a lot about the mind set of being an auditor.
A really good course. The Tutor John was so knowledgeable and gave a very good insight on how an audit is carried out in real terms rather than text book. Very effective and have the confidence to apply the techniques when carrying out our internal audits.
Excellent course from material to training. Would recommend!