Antaris Consulting is the first organisation to be certified to ISO 45001:2018 in Ireland. It was also one of the first technical consultancies in Ireland to achieve certification to ISO 9001:2015 and ISO 14001:2015. These distinctions support Antaris’ ambition to be the leading management systems consultancy in Ireland and it also demonstrates our ongoing commitment […]

The EU’s Regulation (EU) 2017/745 (Medical Device Regulation (MDR)) came into force on 25 May 2017 and will replace the EU’s current Medical Device Directive (93/42/EEC) and the Directive on active implantable medical devices (90/385/EEC). Manufacturers of currently-approved medical devices will have a transition time of three years until May 26th 2020 to meet the […]

ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories moves to FDIS version. ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories published jointly by ISO and IEC (International Electrotechnical Commission) specifies the general requirements for the competence to carry out tests and/or calibrations, including sampling. It covers testing […]

As the development of ISO 45001 progresses ISO/DIS 45001.2 was published in May 2017. It was subject to a ballot of 69 national standards bodies (NSBs) of whom 88% approved and only 11% disapproved. Because this was short of the 25% threshold required for rejection of the text the standard can now move towards the […]

Leaders of the world’s biggest economies reaffirmed their commitment to tackling climate change at the annual G20 summit which took place in Hangzhou on the 4th September last. It was at this summit that the US President Barak Obama and Chinese President Xi Jinping handed their ratification documents to UN Chief Ban Ki-Moon, therefore ratifying […]

International standards make things work. They give world-class specifications for products, services and systems to ensure quality, safety and efficiency. These standards are instrumental in facilitating international trade.  Since the International Standards Organisation (ISO) was established in 1946, it has published 21,000 international standards covering almost every industry from technology and manufacturing, to food safety […]

ISO 13485: Medical devices – quality management systems was published in March 2016. This third edition cancels and replaces the second edition (ISO 13485:2003), which has been technically revised. Rather controversially, ISO 13485:2016 has not been revised in line with the high level structure, HLS, adopted by ISO 9001:2015, ISO 14001:2015 and 30 other management […]