Quality Training

Lead Auditor Training ISO 13485:2016


This CQI & IRCA Certified Blended ISO 13485:2016 Lead Auditor Course is ideal for anyone that wants to gain the knowledge and skills required to perform first, second and third-party audits of quality management systems against ISO 13485:2016, in accordance with ISO 19011:2018 and ISO/IEC 17021-1:2015

Content includes

Three learning objectives/outcomes:
At the end of this course, participants will be able to:
1. Explain the purpose of a quality management system, of quality management systems standards, of management system audit, of third-party certification and the business benefits of improved performance of the quality management system
2. 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, as applicable
3. Plan, conduct, report and follow-up an audit of a quality management system to establish conformity (or otherwise) with ISO 13485 and in accordance with ISO 19011, and ISO/IEC 17021, as applicable

This is a blended learning program, consisting of:
  • 16 hrs of online & self-paced modules (= 2 days training)
  • 4 virtual classroom days (Practical Workshops); 9:00 - 16:30
  • Exam on final day (via eAssessment)

Entry Criteria (Prior Learning Requirements)

In registering for this course, each Learner must have the following prior knowledge before completing this course:
Management Systems
• 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.
ISO 13485
• Knowledge of the requirements of ISO 13485 and the commonly used quality management terms and definitions
• Knowledge of the requirements is a key pre-requisite in attending this course as without a good understanding, the course may be very challenging.

If any Learner does not meet the above entry criteria, successful completion of Comply Guru’s Online ISO 13485:2016 Foundation Course will ensure that they meet the above prior learning requirements.

~ Optional Foundation Course available at a discounted rate For blended participants, 50% of the €395 foundation course cost = €197.50 ~
CQI & IRCA Certified Online ISO 13485:2016 Foundation Course (8hrs). This course is recommended for everyone, both new & experienced Quality Professionals. For any Learners who declare that they fully meet the entry criteria, this course is not mandatory to complete but it is still recommended. A separate CQI & IRCA recognised certificate will be issued upon successful completion.

For Quality Professionals or Engineers, Internal Auditors, Regulatory Professionals.


Successful completion of this course will entitle each Participant to a CQI & IRCA Recognised ISO 13485:2016 Lead Auditor Certificate of Achievement.
Course accreditation held by Comply Guru (Course No. 2244)

Upcoming dates:


Online Virtual, Online
20, 21, 22, 23 Feb 2023. - 16 hours online self paced (= 2 days) + 4 virtual classroom days: 20, 21, 22, 23 Feb. (Online 16hrs to be completed before 20 Feb - Mandatory)
Book now


Lead Auditor Training ISO 13485:2016

Training Days

5 days

Training Location

Available nationally, based on demand

Course Cost

Member: €712
Non-member: €1,195
* Cost quoted per person