08-02 Hazard Analysis


This SOP describes methods for conducting Hazard Analysis following ISO 14971 to establish product risks, prioritize risk reduction efforts and conduct and validate mitigations. Latest ISO TR (24971) is integrated into the SOP.Two matrix forms to guide Hazard Analysis are included as well as a report template.(15 pages + 3 forms)

Webinar slides which explain the SOP and the context of the SOP are included. These could be used for training.

Browse this category: RISK MANAGEMENT SOP GROUP