Quality Training

Internal Auditor Training ISO 13485:2016


This CQI & IRCA Certified Blended ISO 13485:2016 Internal Auditor Course is ideal for anyone that has a good understanding of Quality Management Systems (QMS) and the requirements of ISO 13485:2016 and wants to gain an in-depth understanding of the process for performing internal audits of part of their QMS.

Content includes

Three learning objectives/outcomes:
At the end of this course, participants will be able to:
1. With reference to the PDCA cycle, explain the process-based quality management system model for ISO 13485 and the role of an internal audit in the maintenance and improvement of quality management systems.
2. Explain the role and responsibilities of an auditor to plan, conduct, report and follow-up an internal quality management system audit, in accordance with ISO 19011.
3. Plan, conduct, report and follow-up an internal audit of part of a quality management system based on ISO 13485, and in accordance with ISO 19011.

This is a blended learning program, consisting of:
6 hours of online & self-paced modules (= 1 day training)
2 half day virtual classroom days (Practical Workshop) - Mornings

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 Internal Auditor Certificate of Achievement.
Course accreditation held by Comply Guru (Course No. 2286)

Upcoming dates:


Online, Online
29th, 30th January 2024
Book now


Internal Auditor Training ISO 13485:2016

Training Days

2 days

Training Location

Available nationally, based on demand

Course Cost

Member: €331
Non-member: €595
* Cost quoted per person

"Course very effective as was teaching method used, would recommend."

Norma Conway
Training Coordinator
BD Medical, Dublin