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United StatesISO 13485 Lead Auditor Training for Medical Device Quality Management Systems (MD-QMS)
ISO 13485 Lead Auditor Training is for anyone that wants to gain the knowledge and skills required to conduct full system first, second and third-party audits based on ISO 13485, in accordance with ISO 19011 and ISO IEC 17021.
Our blended learning course is a hybrid approach where you first complete eLearning modules on the underlying theory that better prepares you in advance of attending Live Classes with an Instructor that focus on practical application in a real life context.
CQI & IRCA certify this course (No. 2244) offering global recognition for successful participants.
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Our Methodology
Blended Learning is Better Learning
A two-step methodology with eLearning modules that help you master the theory better preparing you for practical workshops that embed the skills.
Course Structure Explained
Detailed Breakdown & Agenda
Learners first complete interactive eLearning modules to grasp the underlying theory, then attend live, instructor-led workshops emphasizing practical, real-world application.
| Time | Topic |
|---|---|
| 150mins eLearning | Module 1: Overview of ISO 13485
Case Study! Documentation Requirements Case Study! Process Based QMS Case Study! Risk Based Thinking |
| 120mins eLearning | Module 2: Introduction to Auditing
Case Study! Principles of Auditing Case Study! Determining Audit Duration |
| 120mins eLearning | Module 3: Planning the Audit
Case Study! Audit Objectives, Scope and Criteria Case Study! Audit Behaviours x 4 |
| 120mins eLearning | Module 4: Audit Initiation and Preparation
|
| 120mins eLearning | Module 5: Conducting the Audit
Case Study! Communication during an Audit Case Study! Auditee Reactions Case Study! How the Auditor collects and verifies information |
| 90mins eLearning | Module 6: Generating Audit Findings and Closing Meeting
Case Study! Generating Audit Findings Case Study! Non-Conformity Grading |
| 75mins eLearning | Module 7: Audit Reporting, Completion and Follow Up
|
| Time | Topic |
|---|---|
| 09:00 - 10:00am | Introductions Housekeeping: Attendance, Assessments and Course Outcomes |
| 10:00 - 10:15am | Break |
| 10:15 - 11:15am | Practical Workshop QMS Document Review |
| 11:15 - 11:30am | Break |
| 11:30am - 12:30pm | Practical Workshop QMS Document Review (continued) Practical Workshop Development of the Audit Plan |
| 12:30 - 1:15pm | Lunch |
| 1:15 - 2:15pm | Practical Workshop Development of the Audit Checklist |
| 2:15 - 2:30pm | Break |
| 2:30 - 3:30pm | Practical Workshop Development of the Audit Checklist (continued) |
| 3:30 - 3:45pm | Break |
| 3:45 - 4:30pm | Daily Wrap Up with Q&A eAssessment (Final Exam) Preparation |
| Evening Assignment | eAssessment (Final Exam) Practice |
| Time | Topic |
|---|---|
| 09:00 - 10:00am | Day Objectives Practical Workshop Development of the Audit Checklist (continued) |
| 10:00 - 10:15am | Break |
| 10:15 - 11:15am | Practical Workshop Opening Meeting Practical Workshop Simulated Audit (Case Study) |
| 11:15 - 11:30am | Break |
| 11:30am - 12:30pm | Practical Workshop Simulated Audit (Case Study), continued |
| 12:30 - 1:15pm | Lunch |
| 1:15 - 2:15pm | Practical Workshop Simulated Audit (Case Study), continued |
| 2:15 - 2:30pm | Break |
| 2:30 - 3:30pm | Practical Workshop Simulated Audit (Case Study), continued Practical Workshop Generating Audit Findings |
| 3:30 - 3:45pm | Break |
| 3:45 - 4:30pm | Practical Workshop Generating Audit Findings, continued Daily Wrap Up with Q&A eAssessment (Final Exam) Preparation |
| Evening Assignment | eAssessment (Final Exam) Practice |
| Time | Topic |
|---|---|
| 09:00 - 10:00am | Day Objectives Practical Workshop Generating Audit Findings, continued |
| 10:00 - 10:15am | Break |
| 10:15 - 11:15am | Practical Workshop Generating Audit Findings, continued Practical Workshop Audit Conclusion |
| 11:15 - 11:30am | Break |
| 11:30am - 12:30pm | Practical Workshop Closing Meeting |
| 12:30 - 1:15pm | Lunch |
| 1:15 - 2:15pm | Practical Workshop Preparing and Distributing the Audit Report Practical Workshop CAPA Verification and Closure / Audit Follow Up |
| 2:15 - 2:30pm | Break |
| 2:30 - 3:30pm |
|
| Evening Assignment | eAssessment (Final Exam) Practice |
| Time | Topic |
|---|---|
| 10:00am - 12.30pm | eAssessment (Final Exam) |
Course Overview
ISO 13485 Lead Auditor Training
Explain the purpose of a medical device quality management system (MD-QMS), interaction
with appropriate medical device regulatory authority requirements, quality management systems standards, third-party certification, and the business benefits of the quality management system.
Explain the role and responsibilities of an auditor to plan, conduct, report, and follow-up a quality management system audit in accordance with ISO 19011 and ISO/IEC 17021
Plan, conduct, report, and follow-up an audit of a medical device quality management system
to establish conformity (or otherwise) with ISO 13485 and applicable medical device regulatory requirement documents in accordance with ISO 19011 and ISO/IEC 17021
CQI & IRCA certify this course (No. 2244). Upon successful completion, each Learner shall receive a digital Certificate of Achievement.
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.
- 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 printed copy of ISO 13485 (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.
Note: The Learner’s understanding of the prior knowledge requirements will be tested as part of the course’s continuous assessment & final examination.
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 Live Instructor Workshops as 100% attendance is required
- Obtain 70% or higher in the graded assessments during the Live Instructor Workshops
- Complete a 2hr Final Examination* that is remotely invigilated (Live Proctored). Each Learner must obtain 70% or higher in the Final Examination which is completed securely online (under strict examination conditions).
*Note: the final examination is closed book and will assess each Learner on the full course program – including knowledge of the ISO 13485 Requirements.
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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Customer Reviews
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
4.7
Average Rating
607 global ratings
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I am happy with the training overall. The trainer was knowledgeable and supportive during the course.
-
Great outcome from the training. Increased understanding of ISO 13485 from the way the training was delivered and from the trainers experience.
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The curse was very comprehensive, intense in a good way and provided with lot of knowledge, expertise and confidence.
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Very intense course but still enjoyable. The Instructor was excellent and extremely knowledgeable about the standard
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Overall great learning experience, delivered by a highly knowledgeable industry expert.
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