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Why is there currently so much controversy surrounding ISO 14971? During the process of harmonisation of ISO 14971: 2007 as an EN standard, it became apparent that the standard did not comply with all the requirements of the Medical Devices European Directives, namely 90/385/EEC,...
Read MoreISO recently announced that ISO Committee ISO/PC 283 – Occupational Health & Safety Management Systems, has been formed with an objective to develop and publish an international standard for Occupational Health and Safety (OH&S) based on OHSAS 18001. The new standard wi...
Read MoreFigures released from ISO show a large uptake over the previous twelve months. There are over 19,573 standard developed by the ISO since its formation in 1947. The reach of the organisation has expanded with national members 164 countries, rising from 162 in 2011. Ireland’s r...
Read MoreWe are delighted to announce that one of our recent Lean Six Sigma Green Belts, Sean Paul Teeling of the Mater Misericordiae University Hospital had his project shortlisted in the Best Hospital Project category of the twelfth annual Irish Healthcare Awards in Dublin last Thursday...
Read MoreControlling the fabrication environment is not an end in itself. Manufacturers who process and assemble their product in controlled environments know that the clean-room or mini-environment must be appropriately designed and must also be maintained clean and contamination free. H...
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2026