Risk control

ISO 14971 sets an order of priority for risk control: inherently safe design and manufacture first, then protective measures, then information for safety. Each measure has to be implemented and its effectiveness verified.

process (3.14) in which decisions are made and measures implemented by which risks (3.18) are reduced to, or maintained within, specified levels [SOURCE: ISO/IEC Guide 63:2019, 3.12]

ISO 14971:2019, clause 3.21

process in which decisions are made and measures implemented by which RISKS are reduced to, or maintained within, specified levels [SOURCE: ISO/IEC Guide 63:2012, 2.12]

IEC 82304-1:2016, clause 3.16

PROCESS in which decisions are made and RISKS are reduced to, or maintained within, specified levels [ISO 14971:2007, 2.19]

IEC 62304:2006+AMD1:2015, clause 3.18