Risk management

ISO 13485 takes this definition from ISO 14971 and expects a risk-based approach across the quality system, not only in design. The full process, from the risk management plan to production and post-production information, is set out in ISO 14971.

systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk [SOURCE: ISO 14971:2007, 2.22]

ISO 13485:2016, clause 3.18

systematic application of management policies, procedures (3.13) and practices to the tasks of analysing, evaluating, controlling and monitoring risk (3.18) [SOURCE: ISO/IEC Guide 63:2019, 3.15]

ISO 14971:2019, clause 3.24

systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling, and MONITORING RISK [SOURCE: ISO/IEC Guide 63:2012, 2.15]

IEC 82304-1:2016, clause 3.18

systematic application of management policies, procedures, and practices to the TASKS of analyzing, evaluating, and controlling RISK [ISO 14971:2007, 2.22, modified – The phrase "and monitoring" has been removed]

IEC 62304:2006+AMD1:2015, clause 3.19