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United StatesISO 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.
Our industry-leading blended methodology requires Learners to first complete interactive eLearning modules on the underlying theory that better prepares them before attending Live Classes with an Instructor that focus on practical application in a real life context.
For in-house groups, we can also offer an instructor-led format (without eLearning), if preferred.
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Our Methodology
How Blended Learning Works
Blended learning is a two-step approach: Beginning with eLearning modules to grasp the foundational theory, then attending live, instructor-led classes emphasizing practical, real-world application.
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Course Overview
ISO 13485 Internal Auditor Training
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
Overview of ISO 13485
- Introduction to ISO 13485
- Terms and Definitions
- Plan Do Check Act
- Documentation Requirements
- Process Based QMS
- Risk Based Thinking
- Management Commitment
- Related Standards
Introduction to Auditing
- Management System Audits
- Audit Terminology
- Principles of Auditing
- Audit Program Management
- Certification Audit Program
- Audit Lifecycle
Audit Initiation and Preparation
- Audit Planning
- Audit Objective, Scope and Criteria
- Selection of Audit Team and Leader
- Audit Initiation
- Audit Checklist Tools
- Document Review
- Audit Preparation Activities
- Internal Audit Plan
- Audit Checklist
Conducting Audit Activities
- Opening Meeting
- Communication during the Audit
- Collecting & Verifying Information
- Audit Findings
- Non-Conformity Grading
- Document Review
Audit Report, Close and Follow Up
- Non-Conformity Reporting
- Closing Meeting
- Audit Report
- Audit Follow Up Activities
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 (applies to blended format only)
- 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.
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
Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.7
Average Rating
332 global ratings
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Overall, the blended learning course was really good and beneficial. The classroom training could give slightly longer breaks and less breakout rooms, particularly when there is a small group everyone could work together.
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Great way to dip into the requirements of ISO 13485. Absolutely enjoyed the training and the outlook it provides.
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Michelle was excellent in her presentation of the training and the knowledge she shared. Excellent instructor. The course content was aimed exactly to what we needed.
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The classroom training was highly effective, with practical tips on the completion of audits.
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The modules were great but they could have been a bit longer. Overall the whole course was great and I received the knowledge that I was after from it.
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