Author Archives: Antaris Consulting
Food safety is related to the presence of food-borne hazards in food at the point of consumption. As the introduction of food safety hazards can occur at any stage of the food chain, adequate control throughout the food chain is essential. Thus, food safety is ensured through the combined efforts of all the parties participating in the food chain.
In April 2018, ISO published ISO 9004: 2018 Quality management – Quality of an organisation – Guidance to achieve sustained success. This document was prepared by Technical Committee ISO/TC 176, Quality management and quality assurance, which also developed ISO 9001:2015. ISO 9004:2018 replaces ISO 9004:2009. The main changes compared to the previous edition are as […]
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 […]