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.

Why Choose Comply Guru?
 
Comply Guru
Globally Recognized Qualification
Industry-Leading Blended Methodology
Trusted by Regulators, Notified Bodies & Multinationals
Learn from Anywhere
Live Workshops led by Experienced Lead Auditors
More Flexibility & Less Downtime at Work
Better Prepared In Advance of Live Workshops
Course Snapshot
Accreditation
CQI & IRCA (No. 2244)
Duration
40hrs
Available Format
Blended Learning
Price
EUR €  1395.00
Bonus Access
Learners will also receive FREE access to:
ISO 13485 Foundation Training  
Learner Rating
★★★★★ 463 Reviews
Upcoming Dates
13th - 16th May 2024 2:00 PM - 9:30 PM IST
8th - 11th Jul 2024 9:00 AM - 4:30 PM IST
6th - 9th Aug 2024 2:00 PM - 9:30 PM IST
Why Choose Comply Guru?
 
Comply Guru
Globally Recognized Qualification
Industry-Leading Blended Methodology
Trusted by Regulators, Notified Bodies & Multinationals
Learn from Anywhere
Live Workshops led by Experienced Lead Auditors
More Flexibility & Less Downtime at Work
Better Prepared In Advance of Live Workshops

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.

How Blended Learning Works
How Blended Learning Works

Upcoming Schedule

Gain an Internationally Accredited Auditor Qualification

Advance your knowledge and enjoy more flexibility & learning effectiveness with Comply Guru.

Skillnet Discount Eligible

Employed persons in Ireland are eligible for funding supports offered by Irish Medtech Skillnet. Contact us for details.

Discounted Price: €712 per person

Secure Payment

Workshop Dates
Daily Schedule
Course Delivery
Location
Fee
Registration
13th - 16th May 2024
2:00 PM - 9:30 PM IST
16hrs eLearning + 3-days Live Classes + Final Exam
Virtual Workshops
EUR € 1395.00
8th - 11th Jul 2024
9:00 AM - 4:30 PM IST
16hrs eLearning + 3-days Live Classes + Final Exam
Virtual Workshops
EUR € 1395.00
6th - 9th Aug 2024
2:00 PM - 9:30 PM IST
16hrs eLearning + 3-days Live Classes + Final Exam
Virtual Workshops
EUR € 1395.00
26th - 29th Aug 2024
9:00 AM - 4:30 PM IST
16hrs eLearning + 3-days Live Classes + Final Exam
Virtual Workshops
EUR € 1395.00
23rd - 26th Sep 2024
2:00 PM - 9:30 PM IST
16hrs eLearning + 3-days Live Classes + Final Exam
Virtual Workshops
EUR € 1395.00
14th - 17th Oct 2024
9:00 AM - 4:30 PM IST
16hrs eLearning + 3-days Live Classes + Final Exam
Virtual Workshops
EUR € 1395.00
11th - 14th Nov 2024
2:00 PM - 9:30 PM GMT
16hrs eLearning + 3-days Live Classes + Final Exam
Virtual Workshops
EUR € 1395.00

Course Overview

ISO 13485 Lead Auditor Training

Learning Objectives Covered

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

What This Course Covers Covered

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

Planning the Audit

  • Audit Objectives, Scope and Criteria
  • Selection of Audit Location
  • Selection of Audit Team
  • Auditee, Observer & Guides

Audit Initiation and Preparation

  • Establishing Contact with Auditee
  • Determining Audit Feasibility
  • Document Review
  • Audit Preparation Activities
  • 1st and 2nd party Audit Plan
  • Initial Certification Audit Plan
  • Assigning Work to Audit Team
  • Audit Working Documents
  • Audit Checklist
  • Process Analysis
  • Sampling Sheets

Conducting the Audit

  • Opening Meeting
  • Communication during the Audit
  • Auditee Reactions
  • Audit Sampling

Generating Audit Findings and Closing Meeting

  • Audit Findings
  • Non Conformity Grading
  • Non Conformity Reporting
  • Final Audit Team Meeting
  • Audit Conclusion
  • Closing Meeting

Audit Reporting, Completion and Follow Up

  • Audit Reporting
  • Completing the Audit
  • Audit Follow Up Activities
  • Addressing Non Conformities
  • Initial Certification Decision
  • Re-Certification
Course Accreditation & Certificate

CQI IRCA

CQI & IRCA certify this course (No. 2244). Upon successful completion, each Learner shall receive a digital Certificate of Achievement.

What Are The Entry Requirements

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.

How Will You Be Assessed

In order to successfully complete this course, each Learner will need to:

  1. 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)
  2. Fully attend the Live Instructor Workshops as 100% attendance is required
  3. Obtain 70% or higher in the graded assessments during the Live Instructor Workshops
  4. 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.

What Are The Technology 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.

About Our Lead Auditor Training

Learn about how our IRCA Accredited Training is leading the industry for innovation & learning effectiveness

 
About Our Course
 
Why Choose Blended Learning

What Our Learners Are Saying

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Frequently Asked Questions

Yes, we permit transfers to a future date (s) provided the request is made at least 30 days in advance of the live workshops you registered for. No refund is possible if less than 30 days’ notice is given. On a case-by-case basis, if we can accommodate a transfer at less than 30-days notice, we will but this cannot be guaranteed.
Yes, we offer in-house training and if you have 5 or more learners that can be trained together, we strongly recommend arranging for in-house training. With this option, there is the possibility of customizing some elements of the training to your organization. Please request a quote and a member of our team will be in touch to discuss this further with you.
Each Learner is provided with 3 attempts at each final assessment. We strongly encourage all Learners to review the course content again before each attempt (if unsuccessful on an attempt). If unsuccessful after a 3rd attempt, you will not be eligible to continue to the live workshops.
Each Learner is entitled to resit the examination once if unsuccessful in their first attempt. There is a small fee applicable for resit examinations. If unsuccessful after a 2nd attempt, you will need to re-register for the full program.
A blended learning course is a hybrid of eLearning modules and classroom modules (in-person or virtual). Each Learner is required to successfully complete interactive eLearning modules in advance of the live workshops that form the second phase of the training.
We keep our classes to 10 or 12 maximum depending on the blended course, to ensure you can enjoy breakout rooms, activities and Q&As with the Instructor and other participants.
For the live workshops, we use Zoom and Microsoft Teams. Full details will be shared with Learners upon registering for the training. 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.  
Once you have completed the full program, including examination (if applicable), your certificate will be available within 30 business days via your Dashboard once all examination grading has been completed & verified. To access your certificate, you must first submit a short course survey and then the certificate will be available for download/print.
CQI & IRCA Accredited Training Provider

CQI & IRCA Accredited Training Provider

Offering certified courses since 2019

Exemplar Global Recognized Training Provider

Exemplar Global Recognized Training Provider

Offering certified courses since 2020