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 2016, in accordance with ISO 19011 and ISO IEC 17021.
Why Comply Guru?
- CQI & IRCA Certified Training (No. 2244)
- Industry-leading Blended Methodology
- Delivered by Experts with Proven Expertise
- More Convenient, Flexible & Effective Format
- Virtual & In-Person Workshops Available
ISO 13485 Lead Auditor Training
Our Blended Learning Methodology is a hybrid of 16hrs of highly interactive eLearning theory modules that are completed first before attending 3-days (in-person) or 4-days (virtual) of skills-based Live Instructor Workshops that focus on practical application in a real life context.
Face to Face Learning
On successful completion of this course, Learners will have gained the knowledge & skills required to:
- Plan, conduct, report and follow up an audit of medical devices quality management systems to establish conformity (or otherwise) with ISO 13485 2016 in accordance with ISO 19011 and ISO IEC 17021, as applicable
A summary of learning topics within this course include:
- Purpose, Benefits & Structure of ISO 13485 2016
- Terms & Definitions
- Documentation Requirements
- Plan-Do-Check-Act (PDCA)
- Process-based Quality Management Systems
- Risk Based Thinking (RBT)
- 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
- Auditor Roles and Responsibilities
- Auditee, Observer & Guides
- Audit Initiation & Preparation
- The Audit Plan
- Audit Documentation
- Overview of Audit Activities
- Opening Meeting
- Collecting & Verifying Information
- Audit Findings
- Final Audit Team Meeting
- Audit Conclusion
- Closing Meeting
- Audit Report
- Audit Completion
- Audit Follow-Up
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
- 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.
Pricing & Schedule
Gain an Accredited ISO 13485 Lead Auditor Qualification
Advance your knowledge and enjoy more flexibility & learning effectiveness with blended learning.
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
Skillnet Discount Enquiry
Book 3 + Get 1 FREE
Save up to
Why Choose Comply Guru
About Our ISO 13485 Lead Auditor Training
Learn about how our IRCA Accredited ISO 13485 Lead Auditor Training is leading the industry for innovation & learning effectiveness
What Our Learners Are Saying
Read verified reviews from Learners who have completed this course.
431 global ratings
The Lead Auditor course provided by Comply Guru is an excellent way to gain expert knowledge of the field of ISO13485 auditing. Knowledgeable instructor and great class interactions.
This course was excellent! I really appreciated John's extensive experience and advice as well as his practical, positive, and humane approach to auditing. The group discussions and practical exercises were helpful and engaging. I got more value out of this course than I even expected! Would recommend!
I absolutely enjoyed it, it allowed me to think outside the box, challenged my knowledge of the standard and strengthened my understanding of auditing
Great experience overall, and I have already recommended it to some others. One suggestion would be to attempt and incorporate a little more of ISO 13485 training on the front end, it seemed the assumption is that one is already quite good at understanding and using it.
The ISO 13485 Lead Auditor training course is one of the best online courses I've ever been a part of. John's knowledge of the subject from a theoretical and practical standpoint were spot on, and his ability to bring out everyone's experience to share with the entire group was masterful. I really enjoyed taking this course!
Frequently Asked Questions