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9 Key Changes Introduced by the EU Medical Device Regulation (MDR) 2017/745

9 Key Changes Introduced by the EU Medical Device Regulation (MDR) 2017/745

The medical device sector is highly regulated due to the risk to patient safety, including serious illness or death, which is posed by defective medical devices and/or devices that do not perform as intended. In...

Breda Kearney - Quality Director

Author Breda Kearney

Quality Director

6 Key Considerations for Planning a Remote Audit

6 Key Considerations for Planning a Remote Audit

COVID19 has changed the way we work, with the majority of people now working from home due to travel restrictions and social distancing requirements. In the world of ISO auditing, one of the biggest changes...

Breda Kearney - Quality Director

Author Breda Kearney

Quality Director

Celebrating 250 Learners on CQI & IRCA Certified Training Courses

Celebrating 250 Learners on CQI & IRCA Certified Training Courses

Since running our first program in March 2019, we have just passed the 'milestone' of 250 Learners who have successfully completed both our Online & game-changing Blended training courses that are CQI & IRCA certified offering...

Eoin Philip Kelly - Founder & CEO

Author Eoin Philip Kelly

Founder & CEO

New Service – Contract Quality Auditor Services

New Service – Contract Quality Auditor Services

As we regularly train 1st, 2nd & 3rd Party Auditors on our certified Internal & Lead Auditor training courses, we are frequently asked if we would complete contract audits for Customers, well yes we do!...

Eoin Philip Kelly - Founder & CEO

Author Eoin Philip Kelly

Founder & CEO

The ISO 9001:2015 Audit Process

The ISO 9001:2015 Audit Process

Audits are an essential part of every quality management system (QMS) and are used to determine the extent to which the specified requirements, also known as the audit criteria, have been met by the organization....

Breda Kearney - Quality Director

Author Breda Kearney

Quality Director

The ‘Missed’ Value in Foundation Courses

The ‘Missed’ Value in Foundation Courses

Foundation courses are the most underrated and yet arguably the most important course that I would recommend to anyone interested in either implementing a Management System (to meet the requirements of either a Standard or...

Eoin Philip Kelly - Founder & CEO

Author Eoin Philip Kelly

Founder & CEO

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