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 Directives (MDDs), namely 90/385/EEC, 93/42/EEC and 98/79/EC. Seven discrepancies were identified; these ...
Read MoreThere are few personal or leadership development programs which do not require reflection and consideration of how we give and receive feedback. On our programmes Gina and I ask our learners to consider the reaction the mere mentioning of this word has on us physically and emotio...
Read MoreCLP stands for Classification, Labelling and Packaging of Substances and Mixtures Regulations. This framework was established in 2008 for the classification and labelling of substances and mixtures in the European Union which came into force in 2009. The CLP Regulations are based...
Read MoreHere is a letter published in ASQ monthly journal ‘Quality Progress‘ by SQT CPI Tutor Albert Plant: In response to “Narrower Focus” (January 2015, pp 23-28); I believe the author may be confusing failure modes with the causes of the failure modes. The author ...
Read MoreClick here to see our latest post on 45001 published February 2018 In March 2015, Antaris’ Senior EH&S, Quality Consultant Finbarr Stapleton gave a talk in Dublin at the IOSH Conference – Safety in a re-emerging construction sector on preparing for the new Health & Sa...
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