The organization shall determine external and

internal issues that are relevant to its purpose and

its strategic direction and that affect its ability to

achieve the intended result$($s$)$ of its quality

management system.

How has the organization determined

external and internal issues relevant to its

purpose and strategic direction?

How do these affect the ability to achieve

the intended result of the QMS$?$

$4\mathrm{.}1$q$2$ The organization shall monitor and review the

information about these external and internal

issues.

How do you monitor and review information

about these internal and external issues?