Has the risk and opportunity approach always been part of ISO 9001?
Developments Regarding the Context, Risks, and Opportunities

In versions prior to 2015, the word “risk” was not used in the ISO 9001 standard, but the concept of risk prevention was clearly present through preventive actions aimed at avoiding all types of nonconformities.

Since the 2015 version, the risk-based approach has been introduced and applied at three levels:

• strategic (sources of risk related to the external context);

• organizational (sources of risk related to the internal context, the QMS, the structure, roles, responsibilities, and resources);

• operational (sources of risk at the level of processes and activities in design, procurement, production, etc.).

The identification, analysis, and implementation of risk control measures have, in fact, been part of the spirit—if not the letter—of ISO 9001 since its inception.

What was introduced more recently, with...