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The Kelmac Group® has developed a unique tradition of creating learning services that shape the future of conformity and compliance learning solutions for Executive Management, Practitioners and Auditors.

Where others train followers, we train leaders™

ISO 13485 Training Courses | ISO 13485 Certification

There is probably no other industry where the importance of product conformity is as crucial as that in the design and manufacture of medical devices. Standards in any industry are an important way both to safeguard product conformity while simultaneously harmonizing requirements, not only nationally, but internationally as well.

An important step in safeguarding product conformity and ensuring that a manufacturing or design process can consistently produce product of the required standard, is a structured management system. With regards to medical devices, there is no standard that better represents the requirements for a comprehensive management system than ISO 13485. Compliance with ISO 13485 is often seen as the first step in achieving compliance with regulatory requirements.

Increasingly, certification to ISO 13485 is becoming the preferred method for medical device manufacturers and their sub tier suppliers/contractors to demonstrate the intent to comply with applicable regulatory and statutory requirements. Medical device manufacturers who are placing their products on the market within the European Union will need to address compliance with the requirements of the applicable Medical Device Directive and the CE marking process. ISO 13485 is recognized as an aid in supporting compliance with the MDD.

Our ISO 13485 Training Courses

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What our Learners are Saying

When was the last time you enjoyed learning? The only thing our students enjoyed more than the team exercises was our leadtutors. We’ve learned early on that when our experts enjoy what they are doing, the students do as well. Try us out and you’ll see the Kelmac difference.

Would Recommend
Kelmac Group®.

  • "Subject matter can be dry but the tutor made the course engaging. Definitely worth the time."

    Eva Kenyon | 13rd December 2019
  • "This course was very helpful, not only to qualify as an auditor but also, from a medical device company perspective, to get a better understanding of how external auditors prepare, prioritize and execute."

    Hans Boström | 20th November 2019
  • "Makes sense to take a week out to attend this training and immerse in the topic."

    Niamh Quinn | 19th November 2019
  • "."

    Carol O'Sullivan | 19th November 2019
  • "Great course!"

    Maria Ohman | 19th November 2019
  • "This is an excellent training course for those looking to learn what might be involved in supplier based audits, or who are going to complete an audit of another location/ area within the company."

    Geoff Barr | 18th November 2019
  • "N/A"

    William Browne | 17th November 2019
  • "The accelerated approach that Kelmac group deploys for the training is one of the best I have gone through in years. With Excellent facilitator, and interactive classroom environment, participants in the training were able to discuss and lean valuable skills and practices for auditing."

    Monsur Emiabata | 16th November 2019
  • "Very well structured training course, well presented and delivered by John Collins."

    Brendan McKeon | 14th November 2019
  • "Excellent course. Really brings structure to auditing and I refreshed my approach to auditing"

    Noel Kinneen | 14th November 2019
  • "Excellent course. Really brings structure to auditing and I refreshed my approach to auditing"

    Noel Kinneen | 14th November 2019
  • "Excellent course. Really brings structure to auditing and I refreshed my approach to auditing"

    Noel Kinneen | 14th November 2019
  • "Excellent course. Really brings structure to auditing and I refreshed my approach to auditing"

    Noel Kinneen | 14th November 2019
  • "Excellent course. Really brings structure to auditing and I refreshed my approach to auditing"

    Noel Kinneen | 14th November 2019
  • "Comprehensive and worth the time away from work"

    Dale Kimmel | 12nd November 2019
  • "Overall, the course was very good and the delivery of same was excellent. What could have been a content heavy course was delivered in such a way, that it was enjoyable for all who attended."

    Yvonne Recks | 12nd November 2019
  • "After completing this course I have a far greater understanding of the standard and the application of it. I would highly recommend this course to anyone who wishes to enhance their knowledge."

    Grace Hegarty | 11st November 2019
  • "Great introduction to auditing and ISO 13485:2016"

    Melanie Hayden | 11st November 2019
  • "This was a great introduction to the ISO 13485 Standard. As someone working in the Medical Device field I found my level of understanding of the Standard was greatly enhanced and I feel I can apply this understanding to our Quality System. I would recommend this to any person working in the Medical Device Industry. "

    Brendan Stack | 11st November 2019
  • "Overall this is a great insight to auditing for the ISO13485 standard giving direction on what is needed to satisfy the requirements of the standard, how to structure an audit and the correct principles to apply when auditing."

    Tony O'Sullivan | 11st November 2019
  • "Training is not specific to 13485, it is more of a general internal auditor type training program. Beneficial but not exactly as advertised."

    Eoghan McManus | 1st November 2019
  • "Very enjoyable five days, where the expected output was over exceeded, and I would highly recommend the course and the facilitator."

    Brian Lynch | 30th October 2019
  • "I was pleased with the clarity of this training and the focus on practical auditing. Specific examples from the practice of the trainer were both beneficial and fun. Thnak you"

    Roman Provaznik | 30th October 2019
  • "great experience"

    Viktor Siklody | 30th October 2019
  • "It would highly recommend this training course not only to those who already work in Quality department, but also to other members of organisation. This course provided me such a great understanding of importance of well established Quality system withing organisation. "

    GIEDRE KAKTYTE | 30th October 2019
  • "Very good trainer"

    Matthew Cutfliffe | 29th October 2019
  • "Excellent course with a great instructor"

    Edwin Cummins | 28th October 2019
  • "Going forward I will be using some of the techniques learnt on this course, just wish I had done the course years ago."

    Patricia Pepper | 28th October 2019
  • "Going forward I will be using some of the techniques learnt on this course, just wish I had done the course years ago."

    Patricia Pepper | 28th October 2019
  • "Going forward I will be using some of the techniques learnt on this course, just wish I had done this course years ago."

    Patricia Pepper | 28th October 2019
  • "Going forward I will be using some of the techniques learnt on this course, just wish I had done the course years ago."

    Patricia Pepper | 28th October 2019
  • "Going forward I will be using some of the techniques learnt on this course, just wish I had done the course years ago."

    Patricia Pepper | 28th October 2019
  • "Going forward I will be using some of the techniques learnt on this course, just wish I had done the course years ago."

    Patricia Pepper | 28th October 2019
  • "Going forward I will be using some of the techniques learnt on this course, just wish I had done the course years ago."

    Patricia Pepper | 28th October 2019
  • "Going forward I will be using some of the techniques learnt on this course, just wish I had done the course years ago."

    Patricia Pepper | 28th October 2019
  • "Going forward I will be using some of the techniques learnt on this course, just wish I had done this course years ago."

    Patricia Pepper | 28th October 2019
  • "Going forward I will be using some of the techniques learnt on this course, just wish I had done this course years ago."

    Patricia Pepper | 28th October 2019
  • "N/A"

    Philip Green | 28th October 2019
  • "Very good course. Thorough with a lot of information but delivered in a way that doesn't make it seem daunting. Would recommend this course to anyone interested in auditing."

    Aoife Gunning | 28th October 2019
  • "Kelmac provided a very well presented training course via an instructor who was intelligent, had excellent interpersonal skills and a high degree of training experience. the course was indepth but the audience concentration was positive due to the skills of the instructor."

    MICHAEL SKILLEN | 28th October 2019
  • "It is a great course where you can learn about the skills requiered for a lead auditor. It is a very intensive course with a lot of excercices and interaction with the rest of the students."

    Ingrid PLUJA VALLET | 24th October 2019
  • "good"

    Julie Grace | 22nd October 2019
  • "would happily recommend both the course and the trainer this was an excellent course and has vastly helped my understanding of both ISO13485 and ISO19011"

    SAMANTHA ATKINS | 22nd October 2019
  • "N/A"

    Darren Moloney | 22nd October 2019
  • "Excellent course, just wish I'd done it years ago."

    Patricia Pepper | 18th October 2019
  • "John Collins was an excellent trainer and got the group to interact and engage in the topic"

    Matthew Cutfliffe | 18th October 2019
  • "An informative, yet entertaining way to learn both the standard and methods to audit. Something to be learnt for all levels of people."

    Garth Coey | 18th October 2019
  • "Great course and very knowledgeable instructor "

    Colin McClean | 18th October 2019
  • "N/A"

    Holly Cunningham | 17th October 2019
  • "N/A"

    Pierre Bonnevaux | 17th October 2019
  • "Comprehensive overview of course topic with a skilled and knowledgeable trainer. "

    Michael Hutchinson | 17th October 2019
  • "N/A"

    Linda Martin | 16th October 2019
  • "The instructor was extremely engaging, his stories of his training experience helped to enrich the course. the group work helped provide a hands-on approach to learning"

    John Gowran | 14th October 2019
  • "good course"

    Edward Travers | 8th October 2019
  • "Excellent training with focus on practical aspects of auditing. Lot of new details from certification audits for me."

    Filip Vecera | 8th October 2019
  • "I´d recommend this course since it was based on the great Gerard´s experiances that he was able to share with us. Learned the best practice and have helped to answer all questions which were raised. Also I would appreciate how interactive the course he made. Making small teams for solving a specific tasks."

    Ales Wasserbauer | 7th October 2019
  • "None"

    patricia moore | 4th October 2019
  • "Course was very interactive with all personnell"

    Brid Cleary | 3rd September 2019
  • "This training course runs through the principles of ISO 13495 internal quality auditing and encourages participants to take part in interactive activities and exercises. The interaction allows participants to get a feel for the topics being discussed. The instructors have many years experience in auditing and the medical device industry. "

    Brenda Egan | 26th August 2019
  • "Good course which provides an excellent knowledge base and key skills for those interested in participating in internal auditing team in med device industry."

    Eoghan Coughlan | 19th August 2019
  • "well thought out concise yet detailed course which imparts knowledge on attendees"

    Cathal Hanrahan | 16th August 2019
  • "overall good experience "

    Shannen Singh | 16th August 2019
  • "This course was the perfect preparation for allowing me to get started with Internal Auditing. Following the clear guidelines outlined on the course meant the audits can progress as quickly and efficiently as possible."

    Shane MacNally | 14th August 2019
  • "Excellent course would highly recommend"

    Bridget O'Keeffe | 6th August 2019
  • "n/a"

    Jack Kenneally | 2nd August 2019
  • "Very good course. Instructor was very knowledgeable and interactive with the class"

    Brian Stapleton | 2nd August 2019
  • "N/A"

    Thomas Schumacher | 24th July 2019
  • "I liked the training and I believe I learnt very usable information that I can leverage for whole my career."

    Ugur Karaman | 24th July 2019
  • "Everything was fine"

    Erika Minguez | 23rd July 2019
  • "Best training at TÜV SÜD so far. John Collins and Mike McInerey are the most experienced, charismatic and empathic trainer you can hope for."

    Nikolay Molodtsov | 23rd July 2019
  • "Very good training"

    Kevin Masuch | 23rd July 2019
  • "Very good training"

    Kevin Masuch | 23rd July 2019
  • "no comments"

    Isabel Koch | 23rd July 2019
  • "All in all a much better than everage training. I like the approach and I enjoyed it. "

    Michael Beerlin | 22nd July 2019
  • "All in all a much better than everage training. I like the approach and I enjoyed it. "

    Michael Beerlin | 22nd July 2019
  • "All in all a much better than everage training. I like the approach and I enjoyed it. "

    Michael Beerlin | 22nd July 2019
  • "Excellent Instructors, the topic was presented in a way that was both educational and entertaining. The training not only encouraged textbook knowledge, but practical application and understanding."

    Alexander Imhof | 22nd July 2019
  • "Training srated with an ice-braking inroduction round and a very good description of content and expectations of the upcoming week. Themes were presented very good and with lots of helpful examples. Questions could be placed and were all answered very good and understandable. Learning effect was very high."

    Eva Felder | 22nd July 2019
  • "A very engaging course despite the dry topic (13485)."

    Monica Monalisa Scholastica | 21st July 2019
  • "Great course "

    Mark Colfer-Merriman | 16th July 2019
  • "Great way to familiarize yourself with the EN ISO 13485:2016 requirements and prepare for an audit. "

    Nicola Reilly | 10th July 2019
  • "The tutor was friendly, open and interested; the course materials were comprehensive and well ordered. The parts of the course I found most useful was the role play and the overview of key sections of ISO 13485:2016."

    Deirdre Buckley | 3rd July 2019
  • "n/a"

    Michelle Martin | 2nd July 2019
  • "This five -day course is designed to provide a detailed understanding of the role and responsibilities of an ISO 13485 lead auditor, which covers the topics including, audit process and planning, gathering objective evidence and the evaluation of audit findings. The course concludes with a two-hour exam. On successful completion of the course and exam, participants will have met the training requirements for registration as an ISO 13485 Lead Auditor"

    Michelle Martin | 2nd July 2019
  • "Study 13485"

    Herman van Jaarsveld | 2nd July 2019
  • "I am very happy with the way the training was given and evrything I have learned. There is a problem with communication of the results that can be improved. "

    Lubov Delamotte | 2nd July 2019
  • "I am very happy with the way the training was given and evrything I have learned. There is a problem with communication of the results that can be improved. "

    Lubov Delamotte | 2nd July 2019
  • "I am very happy with the way the training was given and evrything I have learned. There is a problem with communication of the results that can be improved. "

    Lubov Delamotte | 2nd July 2019
  • "I am very happy with the way the training was given and evrything I have learned. There is a problem with communication of the results that can be improved. "

    Lubov Delamotte | 2nd July 2019
  • "I am very happy with the way the training was given and evrything I have learned. There is a problem with communication of the results that can be improved. "

    Lubov Delamotte | 2nd July 2019
  • "I am very happy with the way the training was given and evrything I have learned. There is a problem with communication of the results that can be improved. "

    Lubov Delamotte | 2nd July 2019
  • "Course delivered by very experienced trainers in a way that made it easy to learn"

    Noeleen Byrne | 1st July 2019
  • "Take part! It is the best training about ISO 13485 that you can get."

    Daniela Stich | 1st July 2019
  • "The course was very well done and civer all aspects of the ISO 13485. The teacher was well prepared and made fun to learn!"

    Enrico Ercolani Pellini | 1st July 2019
  • "Good Training concept, good Trainer "

    Fengfei Wen | 27th June 2019
  • "It was a wonderfull experience, good didactic and awasome traineer skills"

    Dr Mantineo Matias | 27th June 2019
  • "The training offers a good overview how to apply the standard in practice."

    Manuela Kontny | 27th June 2019
  • "This was the best training I have attended during my TÜV SÜD authorisation time. The content was provided by John Collins in an excellent way. Thank you so much!"

    Kerstin Wekwerth | 27th June 2019
  • "na"

    Micheline Emyegve | 27th June 2019
  • "Highly motivational and big spike in my ISO-Wisdom"

    Jens Rudnicki | 27th June 2019
  • "I would recommend to complete the training with Kelmac Group because of very well performed presentation and huge knowledge of the trainer"

    Rafal Orkwiszewski | 24th June 2019
  • "Very good training course that allows the student to understand how to perform a good audit.Information is presented in a easy to understand manner by a highly experienced trainer. "

    Canice Bolger | 18th June 2019
  • "Great course packed full of fun activities to help learn and understand the standard "

    Alvin Liu | 18th June 2019
  • "N/A"

    Orlaith Halligan | 17th June 2019
  • "In what ways could the training course be improved?"

    Craig Pidgeon | 17th June 2019
  • "n/a"

    Fraser Chambers | 17th June 2019
  • "John was very good with plenty of interaction and fantastic knowledge of the material."

    Glenn Phelan | 17th June 2019
  • "John was very good with plenty of interaction and fantastic knowledge of the material."

    Glenn Phelan | 17th June 2019
  • "This course provides a good grounding in auditing and also knowledge of ISO 13485"

    Avril Aylward | 17th June 2019
  • "Excellent course, will be very valuable for my future career prospects."

    Noel Madden | 13rd June 2019
  • "The course is absolutely fantastic, both if you have little or extensive experience in ISO 13485, ISO 19011 and ISO 17021. Always something to learn regardless of experience, and John did a fantastic job with my questions. Highly recommended."

    Rod Combs | 12nd June 2019
  • "Excellent knowledgeable trainers "

    Lorna Kavanagh | 12nd June 2019
  • "Good course. Highly recommend. "

    Sean McSweeney | 11st June 2019
  • "Good course. Highly recommend. "

    Sean McSweeney | 11st June 2019
  • "Good course. Highly recommend. "

    Sean McSweeney | 11st June 2019
  • "Good course. Highly recommend. "

    Sean McSweeney | 11st June 2019
  • "More emphasis on demystifying what the criteria are saying"

    Rosa Pizzuto | 10th June 2019
  • "The course was useful and suitable for those with no previous auditing experience. However, I would recommend that you request the training manual in advance and familiarize yourself with the contents."

    Jennifer McCarthy | 6th June 2019
  • "My experience on this training was very good. The technical detail was present from the trainers and the discussions on the topics was very informative."

    Alan O'Mahony | 6th June 2019
  • "Yes, met all my expectations"

    Gerard Brennan | 6th June 2019
  • "Good course"

    Declan Clancy | 6th June 2019
  • "enjoyable and enhanced learning on topic and in general"

    Tadhg Dineen | 6th June 2019
  • "Very enjoyable. John was excellent and very knowledgeable. Content was delivered very well and john ensured you had a good understanding of the auditing principles and the context of the ISO standard and required clauses. "

    Rodney Tuite | 6th June 2019
  • "Kelmac course on ISO 13485 Lead auditor course is a great start for all first time auditors and also for experienced auditors to improve their audit practices. The experienced trainers cover all aspects of auditing. I highly recommend this course. "

    Bernady Priya | 5th June 2019
  • "No thanks."

    Niall Dimond | 4th June 2019
  • "An intense week of learning to audit to ISO13485. "

    Helen Brigdale | 4th June 2019
  • "Interesting course presented well"

    Gerry Morris | 30th May 2019
  • "Good course, instructor made it easy to follow and I learned a lot in the 5 days."

    Denise Donnellan | 27th May 2019
  • "Good structure with an excellent trainer "

    Colleen Corcoran | 24th May 2019
  • "Excellent detail and room for discussion to gain a better understanding "

    William Mahon | 20th May 2019
  • "Great to complete and have"

    Donna Duke | 20th May 2019
  • "I would recomend to everybody to complete the course, lenght of time is accurate, plenty of exsercise to refresh memory after each task, practikal part i thought was very good."

    Laura Dambrauskaite | 20th May 2019
  • "Good course with a very good trainer."

    Sean Butler | 15th May 2019
  • "Good course with an excellent trainer"

    Sean Butler | 15th May 2019
  • "course was fantastic"

    Peter Doyle | 15th May 2019
  • "Fantastic Course, Well delivered "

    Peter Doyle | 15th May 2019
  • "Fantastic Course, Well delivered "

    Peter Doyle | 15th May 2019
  • "Very knowledgeable instructor who interacted brilliantly with the class to get the optimum training experience."

    Con Enright | 15th May 2019
  • "I found this course very beneficial to help me understand the purpose of auditing and the different tools used when completing audits. I would definitely recommend it."

    Caroline Butler | 14th May 2019
  • "I found this course very interesting and have a much better understanding of auditing after completing the course."

    Caroline Butler | 14th May 2019
  • "This course is worthwhile taking part in"

    Laura Brophy | 13rd May 2019
  • "It is worthwhile taking part in this course"

    Laura Brophy | 13rd May 2019
  • "n/a"

    Chris Norris | 10th May 2019
  • "n/a"

    Chris Norris | 10th May 2019
  • "excellent trainer, good exercises etc"

    Claire Power | 10th May 2019
  • "excellent trainer , made learning easy"

    Claire Power | 10th May 2019
  • "Well delivered course"

    Aoife Morris | 10th May 2019
  • "Well delivered course. Instructor very knowledgeable. Would recommend to others."

    Aoife Morris | 10th May 2019
  • "Good grasp of the Quality management system. Lots of activities which help grasp the idea of being an auditor. Good for someone who has never audited before "

    Laurie McCarthy | 9th May 2019
  • "Good - Interesting Tutor managed to keep it interesting"

    Ronan Burns | 3rd May 2019
  • "Session encouraged overall discussion rather than section-by-section breakdown of ISO 14971"

    Patrick Dowling | 29th April 2019
  • "N/A"

    Denis Long | 25th April 2019
  • "N/A"

    Kevin O'Mahony | 25th April 2019
  • "n/a"

    George O'Keeffe | 25th April 2019
  • "Longer than needed unless more focus could be added to planning and doing an audit"

    Deirdre Wallace | 25th April 2019
  • "More group participation and group discussions than all instructor conversation"

    Carmel Clancy | 24th April 2019
  • "It might be a good idea to check with participants whether or not they understand and have studied their own particular QMS system or the QMS system in their organisation that they are likely to be asked to audit. Doing the course without ever having previously looked at a QMS system is pointless."

    Douglas Rafferty | 19th April 2019
  • "very helpful training course "

    Alex Stewart | 19th April 2019
  • "very helpful training course "

    Alex Stewart | 19th April 2019
  • "Excellent course. Very helpful, exactly what the team and I needed. "

    killian haycock | 19th April 2019
  • "N/A"

    Rosemary Cummins | 18th April 2019
  • "N/A"

    Sinead Casey | 18th April 2019
  • "Excellent course content, much emphasis on behaviors required to work effectively with people as well as the actual tasks required to complete the audit objectives, content has much applicability beyond auditing"

    John Grace | 16th April 2019
  • "I would highly recommend this course to anyone who is involved in audits. It gives a great understanding of the ISO13485 and opened up to me how much is involved and how many areas are involved with an audit. It gave me a great understanding of how auditors complete audits - how they determine conformities or non-conformities."

    Yvonne Martin | 15th April 2019
  • "I had no auditing experience at the beginning of this course and found the interactive exercises and group discussions really helped me to understand and remember fundamental aspects of this course to take away with me. Excellent course, would definitely recommend."

    Ciara Coleman | 15th April 2019
  • "I thoroughly enjoyed this training, it was interactive which allowed us to apply the skills we were learning throughout this course. "

    Helena Cullen | 12nd April 2019
  • "It will give you a reliable insight into Quality Auditing activities and will put you at ease when completing one."

    Jolanta Wolff | 11st April 2019
  • "The trainer, Michael, was extremely professional, knowledgeable and presented each of the topics very well. The topics were well explained and easy to follow. Michael was able to link many topics to related past experiences / examples. The course also opened up several interesting topics for discussion such as Human error being an effective root cause. I found the course enjoyable and the activities were well timed throughout the course to provide hands on activity to put into practice the topics just discussed. "

    Joanna Cornwell | 11st April 2019
  • "Good overview of the process to start as an internal auditor"

    Kerrie Anderson | 11st April 2019
  • "Excellent course with strong group interaction. Method of learning was very effective and trainer was excellent in his approach. The course was very methodical and easy to follow."

    Paula Prendegcast | 11st April 2019
  • "Lead Auditor course was excellently ran. With Kelmac removing the pressure from the exam at weeks end by slowly building the groups competency"

    Fergal Towey | 10th April 2019
  • "I was dreading the thoughts of a week long looking at slides on ISO 13485, but it turned out that this was one of the best raining courses I have been on, there were only a couple of slides at the beginning of the week and the rest of the 5 days were very interactive and everyone was made feel welcome and encouraged to get involved."

    Martin Gorman | 26th March 2019
  • "Excellent course. "

    Pamela McGeough | 15th March 2019
  • "the location for this week was not always good and also the changes during the week"

    Kerstin Weitl | 11st March 2019
  • "Pace was too fast. Extending the length would be beneficial."

    Alexander Stock | 1st March 2019
  • "As a beginner in auditing QMS systems this course provided a very good overview as well as in depth insights into the challenging profession. The expertise of the instructor in this field is very valueable as he shares his experience well and can communicate also difficult topics in an easy fashion. I can very much recommend this course for all beginners in auditing and probably this could also go for trainees that have just started and like to broaden their view on auditing. Thanks for sharing this experience."

    Egmont Semmler | 1st March 2019
  • "Very interesting training with practicle input."

    Franziska Meindl | 1st March 2019
  • "Please provide some information ahead of the training so that participants have a chance to prepare for the training, e.g. communicate that ISO13485 has to be learned by heart. As many participants have only basic experience with this standard, it would help to take a little bit of pressure away and to focus on other learning content of this course, which is already packed. "

    Julia Gruhne | 27th February 2019
  • "great insight to audit."

    Patrice Fleming | 25th February 2019
  • "overview on EN ISO 13485:2016 - challenge and chance for auditing"

    Gertrud Schönmann | 19th February 2019
  • "The instructor shared his huge experience with the class. Unfortunately, the instructor did not sufficiently consider the training speed and the capabilities of the class."

    Martin Mikyna | 19th February 2019
  • "High quality course and trainer but less time which lead to pressure."

    Stefan Schulze | 19th February 2019
  • "Make yourself familiar with the 3 standards before the training."

    Sonja Töppen | 17th February 2019
  • "Highly recommend this training as it gives a great insight in to how to audit against the ISO13485 standard. The scenarios and worked examples gave food for thought on how best to navigate this ISO standard"

    Carol McMahon | 12nd February 2019
  • "Excellent course, great content and delivery"

    Declan O'Shaughnessy | 11st February 2019
  • "The ISO13485 lead auditor training course was among the best training courses I have ever attended. Trainer was very knowledgeable, encouraged participation by everyone in the group and covered a huge amount during the week. Quality of training manual was very good, very comprehensive. I highly recommend this course."

    Orla Keane | 11st February 2019
  • "The ISO13485 lead auditor training course was among the best training courses I have ever attended. Trainer was very knowledgeable, encouraged participation by everyone in the group and covered a huge amount during the week. Quality of training manual was very good, very comprehensive. I highly recommend this course."

    Orla Keane | 11st February 2019
  • "I loved the course and i found the trainer very much motivating, inspiring and extremely prepared and skilled as a teacher. The course location was adequate and the group small, so that we all were very much followed in a nicely manner. The course material was complete and any additional requirements was provided during the course. Highly recommended."

    Ornella Di Stefano | 5th February 2019
  • "I recommend this course, that proved very useful know how on Quality Management System."

    Annarita Marcelli | 5th February 2019
  • "I recommend this course, that proved very useful know how on Quality Management System."

    Annarita Marcelli | 5th February 2019
  • "Excellent course which improved my knowledge of the standard and auditing in general."

    Paul Loughran | 4th February 2019
  • "Learn about turtles!"

    Patrick Gardiner | 25th January 2019
  • "Really enjoy this training!"

    Marie Dunlevy | 23rd January 2019
  • "Very interactive course enjoyable and entertaining but while at same time improving the students as auditors "

    Eoin McEvoy | 13rd December 2018
  • "Lead auditor training was well presented and very informative. "

    Sean Cunney | 11st December 2018
  • "Being new to the Medical device sector this was a very useful course. It gives the necessary auditor technical knowledge required by the sector both also gave great group interaction with professionals in the field. The course was led by a dynamic and knowledgeable leader The venue and regular refreshment were great. "

    Brian O'Brien | 8th December 2018
  • "I would highly recommend Kelmac Group Lead Auditor training. I really benefited from Gerards years of experience which gave me a better understanding of the requirements of 13485 standards."

    Jonathan Jones | 6th December 2018
  • "Course was very interactive, and I was able to navigate through the standard more confidently. Delivery was excellent. "

    Ursula Brosnahan | 6th December 2018
  • "This was a very enjoyable and informative course. The trainer was very knowledgeable and had lots of practical examples from his experience as an auditor that he was able to share with us. I look forward to applying the audit knowledge and techniques that I learned through this course."

    Suzanne O'Hagan | 5th December 2018
  • "I found this course very valuable, both the content and instruct were of a high standard. "

    Colm O'Rourke | 4th December 2018
  • "Great training with a knowledgeable and competent trainer. "

    Sarah Reilly | 4th December 2018
  • "Overall great expierience would definately recomment to a colleague"

    Elaine O'Connor | 4th December 2018
  • "Thanks "

    Niamh Lynch | 3rd December 2018
  • "Course provided good training."

    Joseph Moran | 3rd December 2018
  • "Good course covering ISO13485 standard mapping; Exam scenarios reinforce learning; good coverage of the principles of auditing."

    Martin Duffy | 28th November 2018
  • "Great week! really enjoyed it - especially hearing all the "real life" experiences and being able to use that knowledge when I am completing an audit myself."

    Jennifer McGrath | 27th November 2018
  • "I learned a lot from this course so much more than I already knew. "

    Eileen Fahy | 26th November 2018
  • "Kelmac Group provided great targeted learning during the course which allowed our small group to focus on areas of concern for the business while undergoing the training."

    Martin Rudkin | 21st November 2018
  • "Excellent trainer, obviously an expert in his field; practical sessions really helped."

    Ana Carnei | 21st November 2018
  • "If you are new to Medical Device, ISO 13485 and/or Auditing this is an excellent course to gain a concentrated learning experience. The course is intense, but enjoyable and rewarding, I feel more confident in making better decisions and being more effective at work. Thank you to both Kelmac Group and our tutor, John Collins."

    Anna Pyne | 20th November 2018
  • "The course was very informative and well delivered. The trainer was extremely knowledgeable and had great real life examples. He kept the course interesting throughout the week."

    Caoimhe McCarthy | 19th November 2018
  • "I attended Lead Auditor training for ISO13485 . I had done Lead Auditor courses years ago and attended to refresh my knowledge. I found the course excellent - not only did I referesh my knowledge but learnt new approaches that will be very benificial to both myself and ny organistaion. "

    Maureen Devaney | 19th November 2018
  • "I really feel prepared auditing ISO 13485"

    Kristina Gramlich | 14th November 2018
  • "The instructors were engaging and relating their real life experiences to the course content kept the course interesting and relatable, very enjoyable, learnt a lot and would highly recommend. "

    Nora Morrison | 13rd November 2018
  • "Very enjoyable, informative and efficient Training, profited a lot from small group size"

    Sarah Lehmann | 13rd November 2018
  • "very knowledgeable and competent trainer."

    Pranav Patel | 12nd November 2018
  • "The training was excellent, and will be very helpful in my professional career!"

    Andreas Kalchschmid | 12nd November 2018
  • "Course was very detailed. Both instructors were well prepared and offered expert advice and opinions. Would recommend Kelmac for other courses."

    Carrie Goode | 6th November 2018
  • "I thoroughly enjoyed the course. I only wish I had completed it sooner. Your delivery combined with real life examples and anecdotes really made the course worthwhile – I now have a heap of work to do to ensure we are demonstrating full compliance before our next audit, but I don’t mind as I feel confident I am fully prepared to address these areas head on. Thanks again, and of course a big thanks to John too. "

    Maria Mc Grady | 6th November 2018
  • "Good exposure and experience"

    Vignesh Murugesan | 4th November 2018
  • "Overall, a great course that delivers on its objectives."

    Kevin O'Connell | 4th November 2018
  • "Guideline on how to prepare for an audit was excellent. Trainers had a thorough understanding of ISO-13485: 2016 and were able to lean on their experience when giving relevant examples. Would recommend this course."

    George Osborne | 2nd November 2018
  • "Gerald and John provided a very good overall training, I would definitely recommend them in future."

    Giovanni Leonardi | 30th October 2018
  • "You WILL learn all you need to know by the end of the week's training"

    Eileen Henley | 30th October 2018
  • "You WILL learn all you need to know by the end of the week's training"

    Eileen Henley | 30th October 2018
  • "Very good course. I feel ready to start auditing."

    Luka Lauridsen | 24th October 2018
  • "Sending reading materials in advance to allow the learner to read through the materials and pre-requisites for the learner to align the course expectation. "

    Vivian (See Mun) Phoong | 22nd October 2018
  • "It was one of the best training I have had. A great instructor, serious and a great learning experiance"

    Martina Gerbec | 4th October 2018
  • "It was one of the best training I have had. A great instructor, serious and a great learning experiance"

    Martina Gerbec | 4th October 2018
  • "It is a very complete course content and exercises. the Professor also was very good"

    Raquel Mico | 1st October 2018
  • "The best of the course was the teacher, how he took care of everybody and how he tried to be understood is admirable! I enjoyed the whole course."

    Mireia Cano López | 27th September 2018
  • "Very good trainer. Well organized training manuals. Correct course pace. "

    Francisco Jose Lopez | 27th September 2018
  • "A very complete course, excellent trainer with a method that really helps the understanding of the ISO 13485."

    Sharon Guerra | 27th September 2018
  • "Very good course, a good way to fully understand ISO 13485."

    Milagros Heras Mayordomo | 27th September 2018
  • "All in all, a very pleasant training! Good group interaction, well-presented examples. Good preparation for exam. "

    Susanne Lauster | 26th September 2018
  • "Very intense and diversified training!"

    Jorg Thon | 26th September 2018
  • "The training was very well presented and interactive. The topics were relevant and I look forward to putting into practice everything I learned on the course. The tutor was enthusiastic and related a lot of the topics we were learning about to real life scenarios which made material easier to understand and remember. I would recommend this training to my colleagues. . "

    Sarah McDaid | 19th September 2018
  • "John made the material very interesting. I would highly recommend other to attend."

    Alan O'Brien | 18th September 2018
  • "The Trainer's ability to make the course interesting and relate to real event situations was a huge plus for this course."

    Dan Cullen | 18th September 2018
  • "John Collins was a great teacher!!!"

    Sascha Stumpp | 13rd September 2018
  • "Good, concise and fun."

    Heike Ellrich | 13rd September 2018
  • "no "Death by power point" - WOW"

    Krutarth Patel | 12nd September 2018
  • "The course was well structured and the trainer presented the contents in a very understandable, memorable and entertaining fashion with lots of examples from the practical field. It was interesting and effective."

    Tim Gebauer | 12nd September 2018
  • "After the training I'm felling confident and prepared to be an Auditor Leader."

    Simone Santana | 7th September 2018
  • "Course structure and activities ensured transfer of knowledge to the learner thus enabling the learner to apply their new knowledge and skills in the workplace. "

    Jacinta Doheny | 28th August 2018
  • "The well-equipped teaching staff are highly motivated and make a vital contribution to the lively, committed teaching"

    Mike Schirmer | 27th August 2018
  • "The training was fascinating although quality management is not the most interesting topic in the world. The trainer was able to give a comprehensive view on the standard. "

    Christoph Lindner | 27th August 2018
  • "The course material is heavy going but delivered brilliantly from the trainer, making it much more understandable and great learning experience."

    James Dempsey | 27th August 2018
  • "An overall good training experience. The course brought me up to speed with what is required to be a lead auditor."

    Anthony Kilgannon | 15th August 2018
  • "Excellent Course. Gained great Insight into ISO13485. "

    Jackie Glavey | 11st July 2018
  • "I found the course engaging and interactive."

    Martina O'Connor | 10th July 2018
  • "very informative and insightful"

    Eamonn Bellew | 9th July 2018
  • "“I really enjoyed this course. I liked the practical in-class exercises which helped to remember the material. I also enjoyed the in-house discussions and quizzes that also helped for the exam. I would highly recommend John as an instructor to those looking to take this course.”"

    Gary Barrett | 9th July 2018
  • "The best complement I can pay to this course and trainer is, although the course is very intensive I could happily begin the course again on Monday morning due to the excellent delivery!"

    Pat Lambe | 9th July 2018
  • "I found the training course excellent, the week flew, the classroom session were interesting and engaging,"

    Anthony Gilligan | 9th July 2018
  • "It was a good course and was well taught."

    Cormac O'Connor | 9th July 2018
  • "Really enjoyed the course"

    Amanda Shaughnessy | 6th July 2018
  • "The training was comprehensive, and delivered in an engaging and accessible way (even for someone with limited knowledge of the topic)."

    Tom O'Dwyer | 21st June 2018
  • "Excellent course"

    Keith O'Sullivan | 20th June 2018
  • "Coming from a base of absolute no knowledge of the auditing process, the course was a great week of learning. The course has given me a great insight into the process which I know will benefit me hugely in my current role."

    Barry Dunnion | 20th June 2018
  • "I found the course to be very practical and informative regarding the ISO13485 standard, specifically auditing"

    Helen Masterson | 19th June 2018
  • "As a student with very little experience in the Quality & Audit processes, this course give me a deeper insight into the course."

    Louise Jordan | 19th June 2018
  • "It was an intense but extremely interesting course gave a very good understanding of the standard and how to look at the big picture and how it feeds into each element of the standard"

    Kathleen Cafferkey | 19th June 2018
  • "excellent course"

    Michael McHugh | 19th June 2018
  • "Great experience."

    Augustina Adagun | 18th June 2018
  • "I have used Kelmac on a few occasions and I have always found them to provide a comprehensive course material to train personnel at all levels in auditing and compliance. The course is explained in depth and the instructors are extremely knowledgeable and helpful, particularly with the transitioning of standards throughout 2018. I would have no hesitation is recommending Kelmac as a training provider."

    David Russell | 14th June 2018
  • "Excellent course. I couldn't recommend it highly enough!"

    David Cole | 14th June 2018
  • "The KELMAC Groupe training was successfully. It forced my skills, abilities and knowledge to become an auditor. I learned how to use the standard, got to know the life cycle of an audit and how to reflected an incident/ audit situation and write a non-conformity in regards to the requirement of the standard. I mean for sure it was a training in theory. However it helped to force my confidence in becoming an auditor. "

    Pia Gunewald | 14th June 2018
  • "I am at TÜV SÜD since May 2018. There is no too much experience available with trainings and courses. But this course has been the best I had in my short time. The trainer was interacting with all students and came back to individual questions. I have not just learned for the exam - furthermore I feel much more comfortable to be ready for my first audits. Thanks for all!"

    Sebastian Alisch | 13rd June 2018
  • "Excellent course and instructor. Great class interaction means you learn as you do. No stuffy paragraphs to trudge through. Would recommend for junior auditors looking for the next step up. "

    Helen Nelson | 6th June 2018
  • "Good training course."

    Michaela Engel | 29th May 2018
  • "Very good course - really good understanding of how to apply iso 13485"

    Neol Conway | 21st May 2018
  • "The course was very good and the trainer answered to all our various questions in detail. It was a very intensive learning experiance for me, because of only 4 course participants. The test was difficult, but we were well prepared for it. "

    Hannah Tegtmeyer | 15th May 2018
  • "Good Training course. Very practical. "

    Donal McGuinness | 15th May 2018
  • "The course delivery of the course material is excellent and the knowledge gained by participants is very useful."

    Mary Hopper | 10th May 2018
  • "I would highly recommend this course for people like myself with basic knowledge of the standards before starting and now i don't know how to do my job with using/quoting the standards. Excellent course and realistic course!"

    Sharon Cooley | 8th May 2018
  • "A comprehensive course"

    Michal Eck | 8th May 2018
  • "Great and knowledgeable trainer who made the auditing course fun and manageable - not an easy task given the subject but John is an amazing trainer and really goes out of his way to ensure every delegate is comfortable. "

    Julie Moore | 8th May 2018
  • "To me coming with a background with very little experience in auditing the course content was provided at a level that 100% met my requirements. I left the course feeling very confident that I could perform an audit under the supervision of a lead auditor. It was one the best courses I attended in recent years."

    Frank Irwin | 3rd May 2018
  • "I strongly recommend ISO 13485 Lead Auditor training delivered by Kelmac Group. "

    Joanna Graj-Jarecka | 3rd May 2018
  • "Excellent course based on auditing and implementation of QMS experience. Really helpful hands on practical exercises. "

    Marta Banaszewska | 3rd May 2018
  • "Great course delivered in a very interactive way - thoroughly enjoyed the course."

    Oilbhe Lawlor | 3rd May 2018
  • "Good course. "

    John Nicholas | 3rd May 2018
  • "Overall very good course. Knowledge shared from Gerard was second to none. Would have liked to use our company specific samples and case studies to gain a greater understanding of how to complete an internal audit"

    David Connaughton | 3rd May 2018
  • "Very well structured course delivered in a very engaging style which encouraged knowledge share between students. The technical knowledge of instructor was excellent!"

    Blessing Nwabude | 2nd May 2018
  • "Accurate training, all relevant topics covered, good opportunity to clarify questions, queries "

    Oleg Fralkov | 2nd May 2018
  • "The course is very informative and very well delivered. There was a verity of different levels of experiences and backgrounds in the group and the instructor was able to lead the group to learn from each other as well as from the instructor himself. The course is very worth while and I would recommend it to anyone in my organisation who was looking to get certified in the auditing process. "

    Andrea O'Brien | 2nd May 2018
  • "Excellent and very informative and engaging trainer. Was able to make the subject matter interesting and was very knowledgeable and responsive. "

    Debbie Wiezel | 1st May 2018
  • "This course is an excellent opportunity for everyone, whether you are only starting working in the medical devices or you have plenty of experience and want to enhance your qualifications."

    Norbert Rosik | 30th April 2018
  • "The learning material, while useful for study throughout the week after course hours, is only part of the training course. Sit back and listen to really get the most from this course."

    Kevin Timmins | 30th April 2018
  • "the course the was run at an upbeat pace that was interactive and informative throughout. the trainers knowledge and ability to relate the course to each individuals experiance kept the long days enjoyable"

    Laura Murphy | 30th April 2018
  • "the course the was run at an upbeat pace that was interactive and informative throughout. the trainers knowledge and ability to relate the course to each individuals experiance kept the long days enjoyable. "

    Laura Murphy | 30th April 2018
  • "The course was well lead and covered the requirements for auditing."

    Neil Plumridge | 30th April 2018
  • "Excellent training course"

    Gerard McLoughlin | 30th April 2018
  • "I did enjoyed training course and recommended to anyone who are interested to do it."

    Elvyra Seskuviene | 30th April 2018
  • "Professional Tutor. Overall very good course!"

    Martins Tihomirovs | 30th April 2018
  • "There was a huge amount of material to be covered but our trainer, John, brought all of the ideas across in a highly relatable manner. He helped to group to interactively explore the area of auditing and used the material to cement our experiences. Highly recommend."

    Louise Corcoran | 30th April 2018
  • "A pretty intensive course covering every aspect of the required programme delivered effectively and comprehensively by a very skilled and knowledgeable trainer."

    Kevin Long | 30th April 2018
  • "Excellent training course. The instructor was key to this. Delivered a very technical training course while including some great real life example, could answer any question put to him but kept an excellent working culture throughout the week."

    Mark Bass | 30th April 2018
  • "Kelmac is very good as adapting the training to meet the needs of the room"

    Geoff Barr | 20th April 2018
  • "I found my training course with Kelmac Group for internal audits 13485:2016 really exciting. Even though I did not have previous experience in internal audits I could follow all the course without any problem. The instructor made the course be very active and interesting. The course material provided was really good and clear. I wouldn't doubt in taking any other course I will need with Kelmac group. "

    Nuria Lopez | 15th April 2018
  • "The two day ISO 13485:2016 Internal Auditor Course was fantastic, the course leader was really fantastic and was adept at ensuring all delegates on the course were following the course material allowing for the various levels of experience. I would certainly recommend. "

    Laura Giffney | 13rd April 2018
  • "This training not only shows you how to internal audit the ISO 13485: 2016 from a fundamentally perspective (compliance & conformity), but also shares a methodology or philosophy of achieving the effectiveness of QMS. It opens my mind from step by step auditing to a more cohesive perspective. "

    Xiaochun Wang | 12nd April 2018
  • "Course was conducted by very good professional."

    Joanna Zorn | 10th April 2018
  • "Very beneficial course, principles and lessons learned could be applied to any form of auditing. Would highly recommend."

    Mark O'Brien | 10th April 2018
  • "There is a lot to learn, but with a group of others sharing their knowledge, you can pick up some great tips and information. The trainers can massively with this. You will leave the course knowing the standard very well, but you must be prepared to put the hours in."

    Russell Lawson | 6th April 2018
  • "Overall and excellent training course that was very well delivered and provided exactly what was asked for."

    Darren Martin | 3rd April 2018
  • "I found the course to be very informative and very well delivered, all of my questions were answered and i felt that nothing was left out. Would i recommend the course to others ? Yes. "

    Darren Martin | 3rd April 2018
  • "learning ISO 13485 in a fast effective way"

    Nicole Fischer | 3rd April 2018
  • "Maybe, as a prerequisite, the learner should complete a trainee audit before the course."

    Marcus Heinzmann | 28th March 2018
  • "I would of liked more actual audit scenarios to be incorporated."

    Scott McPherson | 22nd March 2018
  • "After only having basic knowledge on Audits, I felt that the training has given me a great understanding and more confidence going forward."

    Joanne Kidner | 22nd March 2018
  • "Yes"

    Thomas Theisen | 22nd March 2018
  • "It should be clearer in advance, that you need in depth understanding of ISO13485"

    Georg Malterer | 22nd March 2018
  • "Great course! "

    Joanna Czerwinska | 22nd March 2018
  • "Great course, thank you"

    Joanna Czerwinska | 22nd March 2018
  • "learned a lot in this course which I can use in my field"

    Ferenc Markus | 21st March 2018
  • "Trainer was excellent and very enthusiastic."

    Michael O'Keefe | 15th March 2018
  • "Trainer is excellent"

    Michael O'Keefe | 15th March 2018
  • "Excellent course"

    Kalina Ivanova | 14th March 2018
  • "The course itself was very intense with a lot of information to absorb, especially for a learner like myself with very little knowledge of standards prior to the course. The course was adaptable to our needs as a group based on our previous experience and the exercises were very useful to familiarise with the standard. The trainers were very knowledgeable providing the training with an interactive approach without the use of slides or presentations. The trainers made what initially seemed a very dry subject an enjoyable experience. "

    Rian Thorpe | 13rd March 2018
  • "Excellent training, very interactive with many real life examples, provided by an extremely competent trainer!"

    Oliver Flieger | 13rd March 2018
  • "Course was delivered to an excellent standard"

    Brendan McGrath | 12nd March 2018
  • "Course was delivered to an excellent standard"

    Brendan McGrath | 12nd March 2018
  • "The training is really useful to know about standards and also to do an internal audit or receive and auditor, is practical and it give you confidence. So i really recommend this course. "

    Jose Mascaro | 15th February 2018
  • "Enjoyed the course, thank you"

    Irene Spencer | 15th February 2018
  • "John was an excellent instructor, he had a very comprehensive knowledge of 13485 and continuously gave industry examples to explain details. "

    Emer O'Hare | 15th February 2018
  • "The trainer was very motivational and made the course much more interesting than i expected it to be. He introduced that standards by using stories instead of a death by power-point. All 12 of us found the course interesting, it was a relaxed environment where all were comfortable to contribute. "

    Raymond Delany | 12nd February 2018
  • "The course content and delivery ensured course objectives objectives were met"

    Frank Holian | 12nd February 2018
  • "John's extensive knowledge and experience in the space allowed us to hear real world examples of the practices of the ISO 12485"

    Tim Delany | 9th February 2018
  • "This was a good experience!"

    Mahdi Abbasi | 24th January 2018
  • "Course was very well presentation, trainer was very effective and made everyone feel welcome and part of the group. Really enjoyed the course."

    Carrie Crowley | 17th January 2018
  • "The course was very inspring and motivating for working in the field. I have learned a lot and - it sticks!"

    Uta Bussmeyer | 16th January 2018
  • "Great overview to ISO 13485"

    Sinead Murray | 15th January 2018
  • "Very informative session"

    Teresa Egan | 15th January 2018
  • "It was a brilliant course. I have not studied (and learned along the way) so hard and intensively in a very-very-very long time & I loved every second of it. The course challenges you in many different ways and aspects, it makes (might make) you stop, think and re-evaluate what you already know :)"

    Anzelika Sarapuu | 4th January 2018
  • "While the training is on Lead auditor and should be a generic training it heavily rely on a perfect knowledge of the standard knowing the content of the standard is not enough one need to be able to name the exact location ( section and subsection)"

    Eric COFFIN | 4th January 2018
  • "This training with Kelmac is very good. The instructor’s knowledge, practical experience and real-life examples in the area of auditing is very informative. The course is intense, knowledge of the standard is beneficial before completing the training. "

    GERALDINE O'ROURKE | 3rd January 2018
  • "This is a worthwhile training course. The course is intense with a lot of information. It covers the theoretical aspects of auditing as well as the practical elements. It relates the standards to real life and makes the student interpret the standards to a audit situation "

    John King | 21st December 2017
  • "Thanks Kelmac! Once again you have delivered a powerful training which has improved my skills and knowledge. I greatly appreciate your commitment to ensuring participants leave better auditors with a proper understanding of the standard. "

    Beth Pollard | 21st December 2017
  • "Excellent course content and sharing experiences with other students made learning enjoyable."

    Andrew Llewellyn | 18th December 2017
  • "A very practical course given by an instructor who understands both the standard and the practical application and implementation."

    Martin Crawley | 1st December 2017
  • "The ISO 13485 Internal Auditor Training course was a very informative and valuable course for anybody engaged in Quality Systems Management. The course was delivered in a professional but enjoyable and engaging manner. Group interaction and the sharing of practical examples added value to understanding the practical aspects of the internal audit process."

    Jennifer Hallinan | 1st December 2017
  • "Very good insight into the subject. Very knowledgeable and experienced trainer."

    Stephen Goodwin | 1st December 2017
  • "Very useful course, well presented. Trainer responded very well to the different situations of each trainee."

    Raymond Mcevoy | 1st December 2017
  • "The training course was interesting and informative the cousre leader John was very approachable knowledgable and included a little humour which was refreshing. Overall a valued training expereince "

    Eileen Fahy | 30th November 2017
  • "the knowledge and passion the instructor show was great. I found it easy to learn from John because of his experience and knowledge."

    Mark Kennedy | 29th November 2017
  • "The training provided here was within a small group which allowed the training to be very interactive and could meet our specific requirements. "

    Geoff Barr | 29th November 2017
  • "It was a great training. The group exercises were good and helpful. The trainer had lots of experience and a very good knowledge. It was a hard week with many informations, but very good!"

    Andrea Hemm | 27th November 2017
  • "Very good Training"

    Elisabeth Teuber | 24th November 2017
  • "Very good, real life examples."

    Gunther Burgstaller | 21st November 2017
  • "The course was well presented and very interactive. The Instructor was very knowledgeable and provided a clear understanding of ISO:13485. "

    Katie O'Connor | 9th November 2017
  • "Interesting course with a very engaging trainer. Loads of useful examples illustrated, and we were able to conduct a min-audit providing valuable practical experience and learnings. "

    Avril Finnegan | 6th November 2017
  • "Very valuable, innovative and also entertaining training course for something as boring as ISO 13485 auditing."

    Maciej Grygorczuk | 3rd November 2017
  • "As a first timer to the training course under Kelmac I found it to be a very interesting and engaging exercise. Would recommend this internal auditor training course under John to anyone interested."

    Steven O'Flaherty | 29th September 2017
  • "Good course, would recommend"

    Geoff Waters | 29th September 2017
  • "The course was very interesting and active you would not be bored"

    Fiona Birchall | 27th September 2017
  • "I would highly recommend this training course for those who wish to become certified auditors and those who wish to learn more about the ISO 13485:2016 standard. The trainer, Gerard, was absolutely excellent and a mine of information. His wealth of experience and knowledge and real life auditor stories brought the material to life and really helped the learning experience."

    Caroline Fortune | 7th June 2017
  • "I got more than just the auditor training from this course, I got insight into the application of ISO 13485:2016 and it has been a valuable addition to my continuing professional education. "

    Eimear Butler | 31st May 2017
  • "Good teacher "

    Rolf Schmiegel | 24th May 2017
  • "Very good training material which is well structured, where the delivery of the course is well paced, and where group exercises help to re-enforce the learning experience along with good support from the trainers."

    Sushil Rajput | 16th May 2017
  • "The training with Kelmac was a great experience. Trainers are knowledgeable and have a broad range of experience. This allows for many practical and real world examples to be balanced with the theoretical elements of the ISO13485 content! "

    Thomas Casselden | 16th May 2017
  • "ISO 13485 training was great value and reinforced the key principles of auditing that can b applied to any industry / environmental where internal / external auditing is key to success. Gerard's experience and expertise was key to highlighting real-world examples."

    Christopher Chapman | 9th May 2017
  • "Excellent course well executed"

    Orla O'Brien | 5th May 2017
  • "The coupling between audit and leadership of excellence- and the being given methods to show the benefits of a quality system for top-management"

    Kristian Worziger | 4th May 2017
  • "An intensive but highly informative course. The instructor Gerard was extremely knowledgeable, very approachable and presented the course very clearly with emphasis on interactive group exercises. I would highly recommend the ISO 13485:2016 Lead Auditor course."

    Sharon Stapleton | 3rd May 2017
  • "I have learnt so much about auditing in five days. It has been a pleasure beeing instructed by Mr Kelly, he is so experienced in the field of auditing and medical device. With the six auditing phases as a roadmap I think I will be able to hang up the information efficiently and easily access it during the course of my career as an auditor. "

    Camilla Drott | 3rd May 2017
  • "The training was excellent. It was very intense and you would require a good knowledge of the standard prior to completing the training."

    Marie Walsh | 2nd May 2017
  • "Very logical insight into internal auditing, shows how you can put tools in place to assist in auditing and these can be built on over time. "

    Louise Heslin | 2nd May 2017
  • "Great and experienced instructors, friendly working atmosphere. Enjoyable training, even not easy course to pass. Hard work for all 5 days is needed. I can recomend also to all who have mother language other than English, however good understanding is needed. Ales (Prague, Czech Republic) "

    Ales Martinovsky | 30th April 2017
  • "Brilliant course with great practical examples."

    Serena Moore | 29th April 2017
  • "I am delighted that I decided to do this course. Instructors first class. "

    Elvyra Seskuviene | 29th April 2017
  • "Super Training in ISO 13485 and the practical implementation within organizations. "

    Lars Jensen | 28th April 2017
  • "The course was provided in a professional manner with interaction across the group encourage. Practical examples added value to understanding the practical aspects of the audit process"

    Paul O'Shea | 27th April 2017
  • "Concise information with great examples and interactive learning to make for an easy learning environment.Training tailored to meet the need of each students needs. Very enjoyable and beneficial course."

    Brendan Gamble | 25th April 2017
  • "The 2-day course was a good grounding for Internal Audits. Those with experience of Internal Audits benefited from some useful reminders."

    Christine Brooker | 21st April 2017
  • "Excellent delivery of a complex subject, instructor ensured all understood each section before moving on to the next one. "

    Hazel Gormley | 21st April 2017
  • "Very good course with very knowledge presenter"

    Chris Walsh | 20th April 2017
  • "I learned how to audit using the process and risk based approach and ISO 13485 2016"

    Mary Murtagh | 20th April 2017
  • "Learning in small Groups with Focus on the main topic - excellent"

    Stefanie Breisch | 18th April 2017
  • "Very good training, Thank you for all the effort and all the best"

    Michael Blinder | 7th April 2017
  • "the Course helps significantly to get to know the Standard ISO 13485 and to understand how to read it. The way how to conduct an Audit became clearer now. The Course cotnains many practical exercises, not only theory. "

    Ines Schreier | 7th April 2017
  • "A very comprehensive presentation of the skills and knowledge needed for a Lead-Auditor, reflecting all important changes of requirements with respect to new ISO 13485:2016."

    Maria Christine Bauer | 7th April 2017
  • "Very thorough course, given by excellent trainers."

    Suzanne Condon | 5th April 2017
  • "This is an excellent course for companies that wish to obtain lead auditor certification. The tutor Gerard Kelly was very informative, and his level of knowledge and experience in Auditing is invaluable, and therefore would highly recommend the Kelmac Group as a course provider. I will be looking to complete other courses with the Kelmac Group in the future."

    Mandy Cashman | 5th April 2017
  • "Training was excellent. The detail provided an in depth understanding of ISO 13485"

    Patricia McCabe | 4th April 2017
  • "Overall , the course is very informative and delivered in a manner that the content is clearly understandable."

    Dermot Mohan | 30th March 2017
  • "Very good course, instructor was excellent."

    Aisling Reynolds | 30th March 2017
  • "Very good informative course. I have learned a lot about how to now properly conduct an Audit."

    Aisling Reynolds | 30th March 2017
  • "Very hands on approach with a lot of industry related examples"

    Agnieszka Sypula | 30th March 2017
  • "It was a very practical approach and hands on course with a lot of industry related examples"

    Agnieszka Sypula | 30th March 2017
  • "Extremely informative course, while it is quite intensive, the experienced instructors made it extremely relatable and interactive. "

    Yvonne Kelleher | 23rd March 2017
  • "The course was well organized and cover the topic thoroughly. The materials are very useful as they will come in need when the rules will have to be applied. The instructor was very well prepared, friendly and interactive. There were some exercises and activities to help the knowledge to sink in though I would like to have even more of them. The course was bit intense so I would rather have it one day longer but with more interaction and slower pace. However overall I would rate it as very good training experience. "

    Rut Klinger | 30th January 2017
  • "Amazing training course for people who is new in ISO standards!"

    Raymon Principe | 17th January 2017
  • "I was very impressed with the quality of delivery and competance of the instructor Prashanthi Kola. All trainees were kept focused in the training. The training was delivered with energy and positivity.The training on the second day was adapted to revelvant company requirements based on company information and requirements that Prashanthi picked up the first days training session."

    Larry Dillon | 17th January 2017
  • "The trainer had good presentation skills and interaction with participants. The Day 1 course material was very useful but additional material would have been useful for Day 2 (on IVDR). The knowledge of ISO 13485 was limited in this group so the pace of the course was most likely slower than normal but the trainer adapted to the audience quite well. "

    Sharon Stapleton | 17th January 2017
  • "It has been a good training. The technical knowledge of the instructor was excellent and I have got a good understanding in QMS Fundamentals based on ISO 13485:2016."

    Cesar Lopez Ruiz | 17th January 2017
  • "The traing was very beneficialto to me to understand ISO:13485:2016 as I am only new in my role for my company. The instucter was very clear and easy to understand and was very knowledgeable."

    Graham Bolger | 6th December 2016
  • "Course delivered in a professional manner, at the correct pace with the correct materials. Good understanding of the changes in the standard delivered."

    Olivia Kavenagh | 6th December 2016
  • "Course was excellent. Very informative. Instructors were great. I learn't a lot. "

    Diarmuid Crinion | 6th December 2016
  • "The instructor for the course Prashanthi Kola, was an excellent instructor. she was very well spoken , she answered any questions brilliantly. she thought the course in a way that you wanted to fully comprehend everything"

    Mark Farrell | 5th December 2016
  • "Kelmac group were professional and light hearted. would be good to have questionares that are easily answered or to have the tutor go through more of them. possibly a mock audit with a paragragh of non conformances."

    Vivien Munhui | 5th December 2016
  • "As the Operations Director of the company it gave me an indepth understanding of ISO-13485 from an operations point of view as well as a quality perspective. It gave me clear guidelines on how the company needed to continuously improve and how to do this. It offered an excellent method of using auditing for improvement not criticism. Overall, I would highly recommend this course to our sales team and our Management team."

    Shirley Walsh | 25th October 2016
  • "If you feel you have the skill to audit your company QMS to ensure the safety of the medical devices manufactured; by completing this course, you will receive the knowledge, method and direction to focus that skill to the benefit of the patient. "

    John O Donnell | 21st October 2016
  • "I found this course to be very good. It was very informative and with a small group we could go into alot more detail and depth. It was very good and the tutors knowledge was exceptional. I would highly recommend this course to others."

    Caroline Butler | 21st October 2016
  • "I would highly recommend KELMAC GROUP's ISO 134895:2016 Lead Auditor course. Professional instructor, effective training methods, interactive learning experience enable the students to achieve the course's objectives."

    Lily Goldstein | 25th July 2016
  • "The training is an advanced course, it demands a lot from a student (concentration, dedication, determination), however it is rewarding in the end. Individual becomes more confident in the subject matter, which results in better professional performance. "

    Anja Pavselj-Hafner | 6th July 2016
  • "I recommend this course for any one who wants to gain competence in Auditing career. Go for it, it is value for money."

    Ihuoma Alozie | 5th July 2016
  • "I was very lucky to get this training as the instructors are excellent and experienced for this medical device auditors field."

    Petr Bešťák | 4th July 2016
  • "The course was great, we learned a lot, but you need to be prepared to work hard and completely shut off your daily work for a week."

  • "Excellent course, instructors are very knowledgeable and prepare you well for the exam. Learnt a lot in the week and would recommend for anyone interested in or already working in the medical device industry. "

    Maura Ryan | 4th July 2016
  • "I cannot recommend this course highly enough; the group exercises, individual exercises and role play allowed me to gain extensive knowledge in each aspect of the course. There was a great learning environment whereby everyone interacted with each other well and engaged with the instructors positively. The instructors Gerard and Prashanti were excellent and very approachable."

    Elaine Mc Partlan | 2nd July 2016
  • "This course was amazing. Even if you have no experience as a Auditor the course is delivered in a manner in which you are able to follow and learn."

    Rebecca Scott | 1st July 2016
  • "It was a well run event. The location and size of venue were appropriate to the number of attendees. The instructor made an excellent presentation."

    Tom Healy | 9th May 2016
  • "Very worth while overview of teh porposed changes in the standard. I woudl highly recommend attending this training."

    Fionnuala Gibbons | 29th April 2016
  • "This course was excellent and exceeded my expectations. I had forwarded the course to several of my current customers (3 of whom attended) and industry associates (2 of whom attended), and considering it was free of charge, I was concerned it would be used as a sales pitch. The fact that instead it truly educated the group whilst showcasing the knowledge level in Kelmac was a very successful morning for Kelmac (who I wasn't really aware of before) and a morning very well spent for the attendees - thank you"

    Rita Woodings | 25th April 2016
  • "Excellent course, delivered by an auditor (Gerard Kelly) with extensive knowledge and experience of Auditing Quality Management Systems."

    James Langan | 20th April 2016
  • "The presenter Gerard Kelly has an excellent grasp of his subject and many related subjects. No query or question was kicked to touch. His industry experience and passion for Quality comes through in his delivery. An excellent course on the QMS Fundamentals based on ISO 13485:2016. I would highly recommend him. I would be interested in similar courses on other ISO Certifications which are migrating to new standards."

    Gerry McNamara | 19th April 2016
  • "Very good overview of the topic. The course was more detailed and practical that I would have expected. A lot was covered in four hours. It was very useful in getting us started with the QMS updates and gap analysis. Exceeded my expectations."

    Orla Brennan | 19th April 2016
  • "Informative, informal, relaxed learning environment. "

    Marilla KEating | 19th April 2016
  • "There was excellent interaction between the instructor and the class and examples of experience really brought the point across. The class activities enhances ones confidence and learning on the subject matter. "

    Carmel Day | 25th February 2016
  • "I will highly recommend this course to any body. The instructor was so good and highly intelligent, friendly and ready to answer any questions. thanks so much I enjoyed every part of the training."

    Adaku Victoria Amazuo | 3rd February 2016
  • "The foundation course for the IRCA ISO13485 Lead Auditor Certification course is an essential to the actual 5-day course and provided much of the building blocks of knowledge that was required for the extended course. "

    Prashanthi Kola | 1st February 2016
  • "I have gained a lot of working Knowledge in completing this course regarding the ISO 13485 related to the Medical Device and Chemical Company. I will recommender this course to any one who want to be successful in this area."

    Elodie Ahamide | 1st February 2016
  • "The lead auditor course is an intensive introduction to the auditing process and this course leaves you with a strong understanding of the skill set required to fulfill the role of auditor."

    Ann Meenaghan | 30th January 2016
  • "Excellent course, well delivered, with plenty of practical information. Provided an excellent insight into the requirements of a Lead Auditor."

    Cheryl McCusker | 12nd January 2016
  • "This course help me fill in the gaps for areas that I was of certain about! This will help me portray a more professional, knowledgeable and confident auditor! "

    Don Fillion | 18th December 2015
  • " Excellent course, very relevant material. The knowledge and application of the instructors was very strong."

    Sandra Mullen | 23rd November 2015
  • "The course content received from the Kelmac group was excellent including practical insights in how to apply audits situations back to the ISO standard. The course tutor was very skilled using his previous experience in addition to the theory. I would recommend this course to others "

    Gareth McCullagh | 23rd November 2015
  • "Training on ISO13485 through the Kelmac group was an incredibly thorough and effective method to ensure that all participants recieved the best training in a suitable period of time."

    Philip Boylan | 19th November 2015
  • "Excellent course, the instructors were very knowledgable and really helped us to understand the correct clauses required. I would highly recommend this course"

    Rachal McKibben | 16th November 2015
  • "Can't rate the trainer any better, his experience and knowledge is immense and he gave plenty of real life examples which was helpful. The style of interactive teaching rather than power-point was brilliant, much better at keeping you engaged in the content. Learned loads that I will bring back to my work, and the course will hopefully help me to further my career. Would highly recommend Gerard and Kelmac to future employers. "

    Hazel Pearse | 26th October 2015
  • "Excellent course. Got exactly what I hoped for and much more. Very intensive and detailed, but well woth it. I learnt so much this week!"

    Mandie de Beer | 23rd October 2015
  • "The course provided attendees with a very good understanding of the need for risk management and the process of risk management. "

    Thomas Moore | 29th September 2015
  • "The trainer left us in know doubt that risk analysis is a very important part of the manufacture of medical products especially from a legal view point. He gave a detailed review of the different medical standards and what changes were coming down the line in the next year."

    Con Connolly | 23rd September 2015
  • "Informative course that requires active participation to get the most benefit."

    Marie Claffey | 23rd September 2015
  • "Good knowledgeable course with a strong focus on the importance of procedures and documents associated with Risk Management. Interaction with course coordinator and other course attendees was a plus rather than observing endless slides. "

    Cian O'Sullivan | 23rd September 2015
  • "A comprehensive conceptual, practical and applied training course on the ISO 13485 audit process…"

    Peter Harden | 8th July 2015
  • "I wish to have more time, because the information of content is very high. But otherwise a great and interesting experience from a component Tutor. The knowledge he has is outstanding."

    Poul Erik Pedersen | 7th July 2015
  • "with over 15yrs experience in the medical device field across all aspects, as a program manager I found it refreshing to attend a course that I learned something new. Gerry's in-depth knowledge of the subject matter were critical to the learning process and his delivery style was very open to questioning and collaboration. All aspects were well discussed and Gerry never at any point moved the group on until we were all happy with the clarifications. Excellent delivery, knowledge and it was a pleasure to attend"

    Ger Manley | 5th July 2015
  • "This five-day course was packed with learning activities in an interactive and dynamic style. I'm very glad that I realized that it would be very important to focus on the course and evening learning during the week, as this is an intense course. Thank you, Gerard, for a great week of learning!"

    Susan Alexander | 5th July 2015
  • "This course was very informative with an excellent mix of information about the standard along with supporting industry examples."

    Thomas Moore | 3rd February 2015
  • "Enjoyed the course, it was interesting and it was evident the trainer was an expert in this field which enhanced the course immensely."

    Barry O Farrell | 2nd February 2015
  • "Very experienced tutors, prepared to share their knowledge, made the training course very interesting and useful."

    Tadej Borstnar | 2nd February 2015
  • "The training and interaction with students on this course was excellent."

    Kenneth Kelleher | 2nd February 2015
  • "Intense course with the trainee obtaining a full knowledge of lead auditing to the ISO 13485 standard. Course is given by knowledgeable and approachable trainers and group interaction is very strong. "

    Elaine Feighery | 2nd February 2015
  • "If you are looking for training expertise, knowledge supported by substantial skill and ability, Kelmac are the organisation to deliver it."

    Declan Cahill | 1st February 2015
  • "Excellent course and very informative "

    Ger Butler | 26th January 2015
  • "I felt that the training was very useful and closely matched the information that I was interested in."

    Derek Allen | 26th January 2015
  • "Well worth doing for any company looking to get into the Med Industry"

    David Hannan | 25th January 2015
  • "I felt that the instructor came across very well and engaged with everyone extremely well"

    Tom Clancy | 21st January 2015
  • "Overall very good session."

    Nigel McKenna | 19th January 2015
  • "Excellent course, Gerard is really knowledgeable and great delivery. Really beneficial for all trainee's "

    Clem Mulcahy | 16th January 2015
  • "Instructor had excellent knowledge of the subject and kept me interested throughout"

    Liam Purthill | 16th January 2015
  • "Gerard was very knowledgeable and engaging. He provided many valued suggestions for us to improve our internal processes and be more prepared for any future audits."

    Lauretta Keyes | 16th January 2015
  • "Found the training very informative and instructor displayed an indept knowledge of the requirements of the subject matter."

    David Nihil | 16th January 2015
  • "The trainer was competent, very knowledgeably and to the point. Instructor’s flexibly adapted to the needs of the participants and during the workshop spent most time on the issues of most interest to us. The effectiveness and quality of the training and the competence and skills of the trainers were very high, really enjoyed the training, Agnieszka Piaskowska "

    Agnieszka Piaskowska | 11st September 2014
  • "Experience of trainer was communicated extremely well to a mostly inexperience room. Interaction rather than traditional presentations / lecturing style was extremely beneficial in keeping all participants engaged and effectively communicating the material "

    John O’Shea | 10th September 2014
  • "Very good course and extremely good instructor."

    Gerry Campbell | 9th September 2014
  • "The course was extremely helpful in terms of an overview of the 14971 standard, but was complimented by an experienced instructor who has experience of the on-going audit process. I would certainly recommended this as a starting point for professionals who have to work in conjunction with these requirements."

    Ronan Kennelly | 22nd July 2014
  • "Course was detailed and indepth. Good mixture of group activities and self directed study."

    Siofra Caherty | 17th July 2014

Not All Training Is Created Equal

The Kelmac Group® has developed a unique tradition of creating learning services that shape the future of conformity and compliance learning solutions for Executive Management, Practitioners and Auditors. Where others train followers, we train leaders™

Others train followers. We train leaders.™

Kelmac Group® specialise in Conformity & Compliance learning for Executive Management, Practitioners & Auditors. “The Ultimate Learning Experience”

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Having worked in over 35 countries, we have experience that matters. A wealth of knowledge to share that is invaluable during training for those looking to learn from the best.

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