"The statement of context is new to me along with the risk-based approach. Although I have been in quality for quite some time - understanding what goes where and the application of these "two areas" are a little mind boggling.”
Consider your organization with a given strategic orientation and a quality policy. Your organization is an open system interacting with the environment, it is not wise to define objectives for the management system, for example, without considering the internal and external context. For that reason, organizations assess the environment and determine relevant internal (like process performance, like customer complaints, like downtime, like … ) and external issues (like legislation evolution, like technological evolution, like social and economic trends, like …). Then, your organization can evaluate those issues and see if they can be related with opportunities or risks. For example, a demographic evolution can be seen as an opportunity and an economic trend can be seen as a risk. An opportunit y is something that can help meeting an objective, and a risk is something that can hinder meeting an objective.
You can also look into a process or a product/service and think about the desired outcomes and/or desired performance. Then you can determine risks and opportunities about those expected results.
The following material will provide you information about context and the risk-based approach: