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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®.

  • "As explained above, at the end of the day I would review the most important topics to be clear for next days exam."

    Emilio Perruca | 5th May 2021
  • "Excellent course content, real life experiences shared. Quite intense and long but a great sense of achievement felt by finishing it. "

    Ruairi McCaul | 5th May 2021
  • "I can recommend this training. "

    Ewald Nairz | 5th May 2021
  • "Keep the good things skip the the bad things"

    Christian Clausing | 5th May 2021
  • "."

    Mathias Binder | 5th May 2021
  • "thumbs up"

    Stefan Spillner | 5th May 2021
  • "overall it was generally good."

    Francesco Bianchi | 5th May 2021
  • "intense course, not to be recommended for beginners"

    Esther Fürst | 4th May 2021
  • "A very professional training which teaches not only what the standard tells you but in addition to that how reality looks like."

    Benedikt Bodinger | 3rd May 2021
  • "Excellent course, very good practical examples."

    Renata Vesela | 23rd April 2021
  • "This was an excellent course and I would highly recommend it."

    Hazel Ryan | 22nd April 2021
  • "Prior to training familiarize with the necessary ISO standards for audting and the processes at TUV"

    Denise Bockholt | 14th April 2021
  • "Provides a clear understanding of the role as an auditor and teaches the Do`s and Don` ts of practical auditing in an interactive way. Enhanced by enlightening group work sessions and a huge experience track record of the trainer. "

    Martin Szepannek | 7th April 2021
  • "A really good training and you learn a lot. Familiarise yourself with the three standards ISO 13485, ISO 19011 and ISO 27021 in advance. Otherwise it will get quickly very demand and difficult. "

    Stefan Payer | 29th March 2021
  • "-"

    Gerd Hoffmann | 29th March 2021
  • "no comment"

    Kilian O'Donoghue | 25th March 2021
  • "Agree"

    Padraig Cantillon-Murphy | 24th March 2021
  • "Example case studies were very useful"

    Herman Alexander Jaeger | 23rd March 2021
  • "None"

    Brian Nguyen | 22nd January 2021
  • "excellent training and practice"

    Miao Shui | 21st January 2021
  • "very effective"

    Leslie Schmidt | 20th January 2021
  • "the course instructor was very experienced and related all theory with real life examples. was very tired after this course but full of new perspective"

    Natasja Nystrup | 20th January 2021
  • "Please leave a short review that we can share with others who may be looking to complete the same training as you have so that they can learn about previous students experiences on the training. Thank you!"

    Jan Herzer | 19th January 2021
  • "Very interesting and engaging course, very interactive which aids in the learning and understanding of the content"

    James Hewitt | 19th January 2021
  • "Very interesting and engaging course, very interactive which aids in the learning and understanding of the content"

    James Hewitt | 19th January 2021
  • "A very intensive course about auditing practices that helped me a lot for my professional work"

    Jochen Metzger | 19th January 2021
  • "I would also suggest that the course be done in two weeks, the same content divided into two parts. So that there was a pause between them."

    Dr Jean Gonzales Menezes | 19th January 2021
  • "n/a"

    Eva Bauer | 19th January 2021
  • "Nothing"

    Marina Stempfle | 18th January 2021
  • "Great, informative training. Fully recommend. Informative, well structured and logic. A clear benefit to improve proficiency in the job. All topics, that were advertised, were delivered. Overall: high value and definitely relevant to my job. "

    Mikolaj Krukowski | 18th January 2021
  • "Good training week. "

    SAKINA WILLIAMS | 18th January 2021
  • "hotel training will be absolutely better as remote."

    Lei Zhang | 18th January 2021
  • "n/a"

    Claudia VandeSand | 18th January 2021
  • " The tools and interaction of the course were excellent, an excellent instructor with a lot of knowledge. Highly recommended course."

    Estefania DosAnjosRestrepo | 17th January 2021
  • "Interesting course to learn how the audits should be managed. "

    Alvaro Cambero Cambero | 7th January 2021
  • "I recommend the course it is very interesting and practical"

    Irene Jesus Romero | 7th January 2021
  • "-"

    Nuria Ferri Barranca | 7th January 2021
  • "No comments"

    Yolanda Vega Blat | 7th January 2021
  • "Very interesting course to know deeply the ISO 13485, acquiring the ability to know which aspects have to be achieved and demonstrating it with the statements."

    Joseph Maria Martinez Molina | 4th January 2021
  • "It is a very intense course in terms of content, but you learn a lot to have an auditor's vision. It makes you understand how audits should be. "

    Maria Giner Escriva | 4th January 2021
  • "Good course from a high experienced instructor."

    Jose Francisco Agulló Mateu | 10th December 2020
  • "Good course, good trainer"

    Angel Lopez Perez | 10th December 2020
  • "Interactive session and developed my skills "

    DIVYA GOLE | 1st December 2020
  • "Very enjoyable course with an excellent balance of practical and book learning."

    DEAN SILLS | 1st December 2020
  • "I really enjoyed the course, gain knowledge about auditing."

    LENA DUTKIETWICZ | 1st December 2020
  • "I really enjoyed the course, gain knowledge about auditing."

    LENA DUTKIETWICZ | 1st December 2020
  • "I really enjoyed the course, gain knowledge about auditing."

    LENA DUTKIETWICZ | 1st December 2020
  • "I really enjoyed the course, gain knowledge about auditing."

    LENA DUTKIETWICZ | 1st December 2020
  • "I really enjoyed the course, gain knowledge about auditing."

    LENA DUTKIETWICZ | 1st December 2020
  • "I really enjoyed the course, gain knowledge about auditing."

    LENA DUTKIETWICZ | 1st December 2020
  • "Well chosen start for becoming an internal auditor. The tutor was extremely experienced and well able to explain even more complex tasks and issues. Highly recommended."

    Wolfgang Bottenberg | 30th November 2020
  • "The virtual course is well prepared. The course is focused on the interaction and less about practice exercises. The instructor is very experienced and has a deep kwnowledge of the matter. The course is very recomended to learn the basics for being an Lead Auditor."

    Alberto Paños Garcia | 24th November 2020
  • "Great virtual delivery of this course."

    Gillian Beattie | 22nd September 2020
  • "Instructor kept the discussion very engaging and the team exercises were a great way of practicing new techniques."

    Laura Painter | 21st September 2020
  • "Not only good knowledge of ISO 13485, but also some practical audit experience is required to benefit from this course (the way was performed). For Beginners it is difficult to follow as the course manual is not followed during the training and more explanation would be needed before practical exercises."

    Marianne Brill | 21st September 2020
  • "Great experience, excellent knowledge, experience and support from the trainer, I learned a lot!"

    Ivan Rodriguez | 14th September 2020
  • "If you have experience with auditing, then the course might be good. Not for unexperienced newbies."

    Franz Stadlbauer | 14th September 2020
  • "-"

    Nico Bartholome | 14th September 2020
  • "more time"

    Martin Woywod | 14th September 2020
  • "."

    Ron D'Amico | 14th September 2020
  • "."

    Kurt Pawlitschko | 14th September 2020
  • "I would not recommend this course"

    Sandra Wissmueller | 11st September 2020
  • "."

    Stacey Leech | 9th September 2020
  • "-"

    Oliver Boecher | 9th September 2020
  • "An excellent course, highly involving and tailored on the fly to meet the exact needs of the group."

    Richard Green | 9th September 2020
  • "no comments"

    Ugur Oezer | 7th September 2020
  • "n/a"

    Heidi Naderi | 7th September 2020
  • "It's been an intensive and productive training. In addition to instruction session, there are lots of practical exercise session as well. I've enjoyed the training and learned a lot from it. Thank you!"

    Jie Gao | 4th September 2020
  • "The training course could have been better if the trainer has experience in ISO 13485. "

    Sakina Williams | 20th January 2020
  • "N/A"

    Jane Foley | 13rd January 2020
  • "."

    Carol O'Sullivan | 19th 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
  • "great experience"

    Viktor Siklody | 30th October 2019
  • "good"

    Julie Grace | 22nd 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
  • "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
  • "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
  • "Great course "

    Mark Colfer-Merriman | 16th July 2019
  • "n/a"

    Michelle Martin | 2nd July 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
  • "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
  • "Good course with an excellent trainer"

    Sean Butler | 15th May 2019
  • "Fantastic Course, Well delivered "

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

    Peter Doyle | 15th 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
  • "It is worthwhile taking part in this course"

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

    Chris Norris | 10th May 2019
  • "excellent trainer , made learning easy"

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

    Aoife Morris | 10th 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
  • "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
  • "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 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 Prendergast | 11st April 2019
  • "Excellent course. "

    Pamela McGeough | 15th March 2019
  • "great insight to audit."

    Patrice Fleming | 25th February 2019
  • "Learn about turtles!"

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

    Marie Dunlevy | 23rd January 2019
  • "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
  • "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
  • "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 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
  • "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
  • "Very beneficial course, principles and lessons learned could be applied to any form of auditing. Would highly recommend."

    Mark O'Brien | 10th 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
  • "Great course! "

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

    Joanna Czerwinska | 22nd March 2018
  • "Trainer was excellent and very enthusiastic."

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

    Michael O'Keefe | 15th 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
  • "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
  • "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
  • "Great overview to ISO 13485"

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

    Teresa Egan | 15th January 2018
  • "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
  • "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
  • "Excellent course well executed"

    Orla O'Brien | 5th 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
  • "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
  • "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
  • "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
  • "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”

Trusted Expertise

The quality of our Instructors is the cornerstone of our ability to serve our clients. Our people have real world practical experience and inspire confidence with Learners.

Leading Edge

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Effectiveness Delivered

We are one of the few to objectively focus on and measure individual competency before, during and post-delivery. Many competitors make claims, we show results.

No Death by PowerPoint

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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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