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I came across an interesting article recently in ASQ’s Quality Progress penned by David Hansen in which he makes the point that developing the competency and capability of the problem solvers is just as important as solving the actual problem itself. He defines Organisation Co...
Read MoreISO 9001:2015 is nearly upon us with the revised version due to be published in September. The International Standards Organisation (ISO) recently released a statement stating that ISO 9001:2015 had progressed to the Final Draft International Stage (FDIS); the final stage in th...
Read MoreSince it was first published in 1987, ISO 9001 has proved to be the most popular ISO standard, with nearly 1.2 million organisations already certified to this standard worldwide. It has become quite clear why so many organisations have decided to become certified to this standard...
Read MoreThe ISO 19011:2011 standard outlines the process for auditing an integrated management system. This includes: The principles of auditing Managing an audit programme Advice on conducting an audit on a management system It also advises on the assessment of individuals involved in...
Read MoreDuring 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 ...
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2025