Crimson Audit & Review

Content Audit, Review & Consulting for Medical Device Makers

Selling Cans of Air & Bottles of Sound

Posted by crimsonlanguage on 2014/07/28

A particularly unvarnished post on the Oxebridge blog caught our attention recently. The author, feeling a bit distressed by claims that ISO 9001:2015 requires “risk management”, solicited opinions from risk management professionals – including authors of ISO 31000 (guidance on risk management). The latest version of ISO 9001 includes language related to risk management in the form of a new and rather ill-defined concept: “risk based thinking”.

According to one respondent to the informal poll, “selling risk based thinking would be like selling cans of air or bottles of sound”.

While the debate in the ISO 9001 community rages on (and it will), it’s important to note that Crimson is well ahead of the curve on this through certification to ISO 14971 – the risk management standard for medical device manufacturers. When you work with Crimson, you can breathe easy – that’s the sweet smell of certified, patented risk management.


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