ISO maintains risk has implicitly been a part of the standard since the ISO 9001:2015 revision.  How?  In the new standard, ‘preventive action’ has evolved to ‘actions to address risk and opportunities.’  This changes the Corrective Action – Preventive Action (CAPA) model.  In the past, Preventive Action was implemented as a result of Corrective Action specifically to prevent the recurrence of the nonconformity. Continue reading →