Comply Guru Worldwide Sites

40hrs Blended Course EUR € 1595.00 ★★★★★ 413 Reviews

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
ISO 13485 Lead Auditor Training

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.

Available Formats:

eLearning

eLearning

Virtual Learning

Virtual Learning

Face to Face Learning

Face to Face Learning

Customized Learning

Customized Learning

Learning Objectives Module Content Entry Requirements Assessment Methodology Course Accreditation Technology Requirements

Learning Objectives

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

Course Content

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
  • Communication
  • Collecting & Verifying Information
  • Audit Findings
  • Final Audit Team Meeting
  • Audit Conclusion
  • Closing Meeting
  • Audit Report
  • Audit Completion
  • Audit Follow-Up

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.

Assessment Methodology

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
  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.

Course Accreditation

CQI IRCA

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

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.

Pricing & Schedule

Gain an Internationally Accredited Qualification as an ISO 13485 Lead Auditor

Advance your knowledge and enjoy more convenience & flexibility with blended learning.

Secure Payment

Virtual Workshops
Oct 16th-19th, 2023 9am - 4.30pm GMT+1
EUR € 1595.00
Virtual Workshops
Nov 13th-16th, 2023 1pm - 8.30pm GMT
EUR € 1395 EUR € 1595.00

Early Bird Till 29/09

Virtual Workshops
Dec 4th-7th, 2023 9am - 4.30pm GMT
EUR € 1395 EUR € 1595.00

Early Bird Till 20/10

Virtual Workshops
Jan 22nd-25th, 2024 1pm - 8.30pm GMT
EUR € 1395 EUR € 1595.00

Early Bird Till 08/12

Virtual Workshops
Feb 19th-22nd, 2024 9am - 4.30pm GMT
EUR € 1395 EUR € 1595.00

Early Bird Till 05/01

Virtual Workshops
Mar 19th-22nd, 2024 1pm - 8.30pm GMT
EUR € 1395 EUR € 1595.00

Early Bird Till 03/02

Virtual Workshops
Apr 22nd-25th, 2024 9am - 4.30pm GMT+1
EUR € 1395 EUR € 1595.00

Early Bird Till 08/03

Virtual Workshops
May 13th-16th, 2024 1pm - 8.30pm GMT
EUR € 1395 EUR € 1595.00

Early Bird Till 29/03

Virtual Workshops
Jun 17th-21st, 2024 9am - 4.30pm GMT+1
EUR € 1395 EUR € 1595.00

Early Bird Till 03/05

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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