Eoin Philip Kelly


Why our ISO 13485 Lead Auditor Training Course?

March 09, 2015

For a long time, Kelmac Group® has been active with the Life Sciences sector and none more so than with the Medical Devices industry with ourIRCA Certified ISO 13485 Lead Auditor training course.

For over 10 years, Kelmac Group® was providing ISO 13485 based training to various organizations including initially offering what was known as a variant of our IRCA Certified QMS Auditor/Lead Auditor but with specific emphasis on ISO 13485 (not ISO 9001) under the IRCA variant scheme at the time and offered this course for many years successfully. About two years ago, Kelmac Group® made an agreement with IRCA after numerous discussions to recognize the course in its own right and became the first to obtain this recognition. As a result, Kelmac Group® offer an IRCA Certified QMS Auditor/Lead Auditor based on ISO 13485:2012 Training Course under a unique course accreditation number – A17584. We were originally offering this course in Ireland and it was very well received by industry as the course materials, delivery, case study and examples were tailored specific for the Medical Devices Industry and of course taught by real experts with experience in the Medical Devices sector in terms of industry experience, lead auditing and implementation projects for many, many years.

The Life Sciences sector has continued to grow successfully in Ireland and over the years we have delivered this training in the UK, U.S, Latin America and abroad.

Kelmac Group® are now offering this class publicly in Ireland, UK and U.S. It is also available to be delivered onsite to clients for groups of 4 up to 20 per class. Where a class exceeds 10 students, a support instructor is required (IRCA requirement). Additionally with any lead auditor training course, it is strongly recommended that the individual attending has a good working knowledge of the requirements of ISO 13485.

That is an important piece as IRCA have changed their approach in how they wish for training organizations (TOs) to approach lead auditor training. What does that mean? In days gone by, it would have been relatively common to find that a large part of day 1 and 2 of the training would have been spent working with the standard where that is now not permitted, in fact, the standard requirements receive little to no time beyond an overview so its important the individual attending is aware that this is standard among all IRCA training organizations and not just Kelmac Group®.

So where the course before some might argue was more ‘comprehensive’, the training is designed to be comprehensive in respect of the auditing skills, specifically lead auditing and does cover a skillset for internal (1st party), supplier (2nd party) and external (3rd party) auditing.

What are some the benefits of our training?

  • We are very passionate about our training on all our lead auditor courses. Why might you ask? Well we have sought to completely transform our lead auditor training into a ‘live simulated audit’ which is 60% of the total student-centered time. One of our core training moto’s is no more death by PowerPoint – meaning very little slides but more engagement, hands on and interactive – which is based on the latest best practices for adult learning.
  • In addition to that, our courses have an online pre course assignment before the class commences (to be completed by any participant 1 week in advance of the planned course start date). Why? Often on these types of courses, those attending come from varying backgrounds with varying experiences and knowledge on either the standard requirements or key areas covered on the training. So in order to achieve a dual effect of verifying that a student has met the course prerequisites (as mentioned earlier in relation to being familiar withISO 13485 requirements, some courses, such as FSSC 22000 have a number of other prerequisites, you should ensure you check that carefully in advance before booking) but secondly, it confirms that everyone on day 1 of the training is at the same base level and has already starting thinking about certain key topics before they ever come on the training. What was the impact? Well we obtained a marked improvement in both in-class performance and final examination performance including a higher than average student success completion rate based on published IRCA annual statistics.
  • Our performance based training goes beyond IRCA requirements, covering all of Kirkpatrick’s level 2 and 3 and some of 4 which is a fine achievement.
  • On a side note, we also provide our students with access to an online library of relevant ISO standards, additional reference and study material in advance of the training and available for a limited period upon completion of the training too. This was only possible through our technology partner, WatchDox with the latest in encrypted security enabled us to securely share our library of standards with our students whilst they have only a specific, available time to view the document – they are not able to download, copy or print the standards as they are strictly copyrighted documents.

Where can you learn more?

Well, if you navigate to our training section under ISO 13485, you will find a list of available training courses which include training on the requirements, internal auditor, lead auditor courses and some other tailored training. Not all courses are available for individual sign up on a public course, but all training courses are available to be delivered onsite at a client facility for groups and courses can also be tailored to meet specific needs and requirements.


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