Recognised Consensus Standard

ISO 14971 has been adopted by the European Committee for Standardization as EN ISO 14971 2012 [6]. Importantly it is one of the harmonised standards which manufacturers are obliged to comply with if they wish to certify their product as a CE Marked medical device (including in vitro diagnostic devices). Similarly in the US, the 21 code of federal regulations requires risk management to be undertaken as part of design validation (820.30 (g)). ISO 14971 is a Recognised Consensus Standard which the FDA expects manufacturers to comply with to meet this requirement. 

Already the Consensus Document on Quality Assurance (OECD No. 4, 1999) had recognised that these two possibilities would not sufficiently describe the real-life inspection activities of a Quality Assurance unit, and the revised GLP Principles have acknowledged this extended view of inspection types. Inspections dealing with the conduct of, and the activities within, a study are now further subdivided into two different types, so that there are finally three types of inspections, which are just named in the OECD Principles, are described in the OECD Consensus Document on Short-Term Studies (OECD No. 7,1999), and which have to be further specified by Quality Assurance Programme Standard Operating Procedures. These three types are ... 

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