What are the documentation requirements?
Developments Regarding the Context, Risks, and Opportunities

Historically integrated into quality management systems—either implicitly or explicitly—documents detailing risk identification, risk assessment, and the monitoring of control measures are quite common in companies.

Examples include:

• tables related to the analysis of the external and internal context (see Section 4.1 of ISO 9001), showing the risk, whether it has been addressed within the QMS, and any need for additional action, its implementation, and its monitoring (see [