Our Blog

In this section of our website, we are sharing news, updates, relevant opinion articles and insights by our experts & other contributors. We will also share achievements and other related content from all of us at Kelmac Group®


Brian Lyons

Professional Services Manager

ISO 14001 – Your Organization, Your Environment

March 09, 2015

ISO 14001 is the world most popular environmental management system standard. As of 2013 it is currently implemented by 301,647 [1]organisations worldwide, so it must obviously work and its voluntary! Environmental management is all about how a company interacts with the environment and how it manages that interaction. It’s where the company figures out how it interacts with the environment and decides how best to control and manage its products, services and activities that affect the environment. In simple terms, ISO 14001:2004 is about putting a structured management approach in place that lets you identify your interactions (aspects and impacts), figure out which ones need to be managed closely (significant aspects),…


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…


Declan Cahill

Consultant

Why Quality Systems fail to deliver

March 09, 2015

Based on my experience, I believe the following: Top Management are very busy people and are responsible for the full remit of the enterprises activity. Delivering the performance of even a small organization has a multitude of valid distractions, i.e. clients requirements, the need to deliver revenue, operational requirements, the weight of statutory requirements that the enterprise are legally required to comply with. So why do Quality Management Systems fail to get the serious attention of Top Management? Top Management very often do not see the full advantages of what ISO 9001:2008 and later this year ISO 9001:2015, deliver to the enterprise. It is often delegated to an internal member to delve into the requirements of …

Brian Lyons

Professional Services Manager

Managing Legal Requirements – A 5 Step Process

March 09, 2015

So what does this mean for your organization and how do you meet these requirements, given that, and I assume, you’re not an attorney or legal expert? Let’s look at this requirement in 5 simple steps: What does “legal and other requirements” actually mean? How do I find out what these “legal and other requirements” are? There are tonnes of legal requirements! How do I narrow this down to my company? How do I show evidence of compliance? How do I keep up to date? Let’s look at these steps one by one……….. What does “legal and other requirements” actually mean? Clause 4.2.3 of both ISO 14001:2004 and OHSAS 18001:2007 require an organization to have a procedure…


Dr. Martin Knox

QMS, EMS, OHS Lead Assessor & Trainer

Why ISO 9001 Certification?

February 17, 2015

ISO 9001 Certification is a TOOL to manage your organizations’ risks and not something that’s a nice-to-have. The new version of ISO 9001 puts particular emphasis on the risk management of processes, which the 2008 version did not address. Why do companies register for ISO 9001 certification? Over many years of auditing clients in a variety of industry sectors, I have encountered organisations that range in commitment from poor players who register for reasons that are not convincing to those that see the business benefits. The reasons for registering to the standard can vary significantly from client to client: these could be ISO 9001 Certification is Nice to have A customer requirement …


Eoin Philip Kelly

President

What to expect with ISO 9001:2015 Certification Training

February 03, 2015

For the better part of the decade, the auditor training courses at Kelmac Group® focus on linking the needs of the business to the management systems rather than stand-alone, independent systems that might ‘tick the box’ and we are delighted to see changes introduced in the latest revision. Important improvements in leadership, scope and risk-based thinking have also been addressed. In the case of leadership, Kelmac Group has been working with clients to integrate the business with the quality system for higher performance, value and results. With the latest ISO 9001:2015 system, these elements are already built in rather than the quality system operating independently. However, each organization can decide how far they wish…


Eoin Philip Kelly

President

Kelmac Group delivers training in Saudi Arabia

March 09, 2014

Mr. John Collins, Lead Instructor, Kelmac Group was delivering the training and was supported on the 2nd course by Dr. Farooq of QSCert Saudi. The training has been excellently received and the students have responded extremely positively to Kelmac Group’s training design & 5E approach in delivery. We are very excited about this new partnership in Saudi Arabia and look forward to many more courses being run with our new partner in 2014 and beyond. (In the picture above: John Collins – Kelmac Group (centre), Mr. Mohammed Ali – General Manager, QSCert Saudi (far left) & Dr. Farooq – QSCert Saudi (2nd far left)


Eoin Philip Kelly

President

Temetra achieve ISO/IEC 27001 Certification

March 09, 2014

Challenge Temetra, a leading provider of cloud based meter data management for water, gas and energy requested that the Kelmac Group® help it with a full-blown review of its operation and the establishment, development, and implementation of an information security management system based upon ISO/IEC 27001. The meter data management organization was responding to the increased external and internal requirements of corporate governance, compliance, market expectation and company reputation. The Kelmac Group® was asked to meet a number of objectives, including examining and refining the organization’s overall information security philosophy and strategy in the context of the organization’s professional values and reputatio…


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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