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Quality Standard ISO 9001:2015 is nearing publication

Since 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...

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ISO 19011 (1 of 4): Preparing for an Integrated Management Systems Audit: ISO 19011:2011

The 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...

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Notified Body View of Implementation of EN ISO 14971:2012

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 ...

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Feedback – the power to develop (if we let it)

There 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...

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CLP regulations come into force this June

CLP 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...

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