ISO 9001:2015 focuses its attention on your quality management system and one of the key components that can be easily misunderstood is Clause 4: ‘Understanding the Organization and its Context’.
It reads as follows:
“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 do we tackle this particular requirement?
To start, it’s important to understand what this clause is trying to achieve. Your business doesn’t operate in isolation, or a silo. It is part of several different ecosystems that will all have an effect on your quality management system and how it operates. So, understanding this context can help to make your system more robust to influences from other stakeholders who interact in your space.
When you’re looking to identify these potential issues, we can split them into those that are external to the organization and those that are internal:
- External issues are things that are outside of your immediate control. For example, the socio-political, regulatory, and economic landscapes that you find yourself in will influence how well your quality management system can function. Add to this your competitors and your external stakeholders and you’ve got a lot of different factors that play a key role in your operations.
- Internal issues are those where you have more slightly control. They include your company mission, the workplace culture, your organizational structure, the strategic objectives, process flows, and the like. These all have an impact on your quality management system in some way and it’s important to acknowledge these influences as you go about building your system.
Every organization is going to be different, but the key is to think carefully through these different influences and document everything that can have an impact on your systems. In essence, you’re looking to anticipate how the behavior of external actors and systems could impact how your own organization performs. By doing this, you’ll undoubtedly encounter certain risks and potential opportunities that come about purely by being in your unique context. And you can then deal with them.
When you do this well, you’ll have a much more holistic view of where your organization sits, and you can use this information to improve the way you do things for long-term sustainability.
Make your quality management system more robust to external and internal influences with our expert guidance. Don’t miss this opportunity to improve the sustainability of your organization. Contact us today to start the process!”