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. [Read more…]
Creating a reliable product that meets customer expectations is risky.
What is risk and how does one go about managing risk? The recent set of ISO standard updates elevates risk management.
A starting place is a definition. [Read more…]