That assumes a static situation. An example I like to offer about the importance of organizations assessing their context:
During the last 10 years, many machine shops in the US, seeking additional work from new clients, decide to pursue work in regulated industries such as medical devices and aerospace, after spending decades working solely for "commercial customers".
The moment a machine shop decides to pursue work in regulated sectors, the "game" has changed significantly, not only because of heightened regulations and all of it's implications, but industry requirements, such as the need for First Article Inspections in aerospace jobs. The amount of effort consumed by an FAI can be huge and, in itself, eat all the profit margin the supplier thought they would have, if they have no experience quoting jobs for aerospace customers.
Assessing the context of the organization is critical and needs to be paid attention to because the external market is changing ever so rapidly, in most supply chains. I suspect, many organizations will not understand the importance of the task at hand, and, like internal audits, do the least possible to "pass" an external audit, failing to gain insight of the internal and external ever changing conditions and tweaking it's QMS accordingly.
