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 and ISO/IEC 17021

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.

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 training event, Online
19th, 20th, 21st, 22nd February 2024
Book now


Lead Auditor Training ISO 13485:2016

Training Days

4 days

Training Location

Available nationally, based on demand

Course Cost

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