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ISO 9004 Overview April 2018

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 …

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Implementing ISO 45001:2018

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 …

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EU Medical Device In Vitro Diagnostic Medical Device Regulations November 2017

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 …

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