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Limerick-founded SME Kelmac Group collaborates with Lero on a €280,000 R&D Project

February 08, 2017

Limerick-founded SME Kelmac Group collaborates with Lero on a €280,000 R&D project to transform it into global internet player–       Kelmac Group® to double Irish workforce and open international R&D technology centre at Plassey Technological Park, Limerick Limerick, Wednesday, 8th February, 2017: Kelmac Group®, a Limerick based standards and compliance company, is collaborating with Lero, the Irish … Continue reading Limerick-founded SME Kelmac Group collaborates with Lero on a €280,000 R&D Project


Eoin Philip Kelly

President

Why our ISO 13485 Lead Auditor Training Course?

March 09, 2015

For over 10 years, Kelmac Group® was providing ISO 13485 based training to various organizations including initially offering what was known as a variant of our IRCA Certified QMS Auditor/Lead Auditor but with specific emphasis on ISO 13485 (not ISO 9001) under the IRCA variant scheme at the time and offered this course for many years successfully. About two years ago, Kelmac Group® made an agreement with IRCA after numerous discussions to recognize the course in its own right and became the first to obtain this recognition. As a result, Kelmac Group® offer an IRCA Certified QMS Auditor/Lead Auditor based on ISO 13485:2012 Training Course under a unique course accreditation number – A17584. We were originally offering this course …


Eoin Philip Kelly

President

Another Successful ISO 13485 Lead Auditor Training Class

March 09, 2015

This particular Kelmac Group course is one of only two accredited lead auditor training programs in the world for the Medical Devices Industry (based on ISO 13485). The training was delivered by Mr. Gerard Kelly (CEO, Lead Instructor, Kelmac Group – second from left) and by Mr. Brian Lyons (Professional Services Manager, Lead Instructor, Kelmac Group – second from right). The training was a successful event with 11 students attending. In previous blog posts, I have discussed the merits of this class as it is specifically designed for the Medical Devices Industry – a growing industry worldwide. We look forward to running more successful training events like this class in the future! Keep up-to-date with information available…


Anna Miedzinska

Medical Devices Consultant

The Goal of effective Quality Systems based on ISO 13485

January 09, 2014

The Medical Device QMS standard ISO 13485 takes this very approach and shows us how the organization’s activities all interrelate and how they can be made to work in sync. In the Medical Devices world a key principle is the Risk connected with the use of the product. Risk evaluation should be the basis for most decisions in a medical device organization. It is also used by regulatory and statutory agencies to determine the extent of activities necessary at each medical devices organization and the oversight necessary from agency’s side. We need to keep in mind also the Eight Principles of Quality Management, which form the basis for the series of ISO quality management standards. These are: Customer Focus Lead…

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