ISO 13485 Lead Auditor Training is for anyone that wants to gain the knowledge and skills required to perform full system first, second and third-party audits based on ISO 13485, in accordance with ISO 19011 and ISO IEC 17021-1.
Why Comply Guru?
- CQI & IRCA Certified Training
- Industry-leading Blended Methodology
- Delivered by Experts with Proven Expertise
- Less Fixed Classroom Time
- Learn Online from Home or Work
Key Course Information
What you need to know?
Our 40hr Blended QMS Lead Auditor Training course 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 a quality management system to establish conformity (or otherwise) with ISO 13485 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
- 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
- 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
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.
CQI & IRCA certify this course (No. 2244). Upon successful completion, each Learner shall receive a digital Certificate of Achievement.
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 Internationally Accredited Qualification as an ISO 13485 Lead Auditor
Advance your knowledge and enjoy more convenience & flexibility with blended learning.
Frequently Asked Questions
Reviews & Ratings
413 global ratings
the training was provided in very professional manner. The tutor was very professional and positive, provided great knowledge.
Very effective means of achieving training goals, with immediate use of skills being applicable to job role.
Very good instructor. Very knowledgeable and created a good atmosphere. The course was fast paced so you had to keep up.
Great trainer, good pace during the training
A thoroughly enjoyable training course which had a perfect blend of knowledge, instruction and application of the ISO13485 standard. John Collins was an excellent tutor with a world of knowledge who made the whole experience worthwhile and fun.
This course was extremely interactive and engaging. I really enjoyed the content, and the instructor was fantastic at answering all queries the group had. It was a great learning experience, and I would definitely recommend to anyone looking to deepen their understanding of both 13485 and the auditing process!
I really enjoyed the course, I thought John was fantastic, he used his knowledge to give us training, he was interactive and gave real life situations and examples. I loved all the group activities, it exceeded my expectations!
I really enjoyed this training course and I felt like I gained alot of knowledge of the standard which will better elevate my everyday work
The content is extensive, complete and makes sure we have mastered the requirements very efficiently. Best value option for the lead course on the market.