Mark Hammar With the latest release of AS9100 Rev D, there has been a new requirement added for implementing an aerospace Quality Management System (QMS): understanding the context of the organization. This requirement is included at the very beginning of the standard, as it is the first piece of information that is important to consider when planning the implementation of the Quality Management System; but, what does the requirement mean?
What is an organization’s context?
One online definition of “context” is the circumstances that form the setting of something, so that it can be fully understood and assessed. This is exactly what the AS9100 standard has in mind; what are the circumstances that your organization works within that will allow you to fully understand and assess decisions for your Quality Management System? What are the issues that you need to understand that provide a framework for your organization and for your QMS?
What is stated in the requirement?
Understanding the organization and its context is clause 4.1 of the AS9100 Rev D standard, and it only contains two short sentences with three notes. The requirement is simply that you determine, monitor, and review issues that are relevant to the organization’s purpose, strategic direction, and the ability to achieve the results that are expected from the QMS. These issues can be either external or internal, and as per note 1 can include both positive and negative factors or conditions to consider.
External context vs. internal context
As is detailed in note 2, by considering the external issues you can understand the external context of the organization – the circumstances outside of its control that affect it. These can include issues arising from competitive, market segment, legal, social, cultural, technological, and economic environments that affect the organization – for any level of external force such as local, regional, national, or international factors. What issues outside of your company can affect you?
As with external issues, note 3 outlines what to consider for internal issues to understand the internal context of the organization. Internal issues can relate to company culture, values, performance, and knowledge. Every company is different, and understanding how you differ from other companies can help you to identify what sets you apart, and will give you a context for your QMS. For instance, if you have a culture where everyone considers it important to check their work before passing it on, you are dealing with a positive cultural trait that can help with implementing the QMS. However, if your company culture is to never ask questions, then this might be a negative cultural trait that you need to work against in implementing your QMS.
Where do you start, and how do you proceed?
It may seem like the first thing you want to do is to start listing issues, but I think there is a better way to approach the task of understanding your organizational context, and this is a simple four-step process:
- Define the purpose, strategic direction, and intended QMS results: Before understanding the context of the organization, it is important to define what the organization is, and these three pieces of information do just that. What is your organizational purpose? What is the strategic direction that you are planning for your company; what is your vision of the future? What do you intend to happen when you have a well-functioning QMS; what benefits will you get? By performing these tasks, you will be defining what your company, and your QMS, is.
- List all issues: Now you can list your issues in a systematic way. List all of the external issues you can think of and identify on the list how they are relevant to your purpose, strategic direction, and intended QMS results. Only leave on the list those issues that are relevant. Now do the same with your internal issues. You will now have a list of issues that affect your company to use as you make plans for implementing your QMS.
- Use your list during implementation: As you work through the other requirements of AS9100, you will find that this list of internal and external issues that are relevant to you can become invaluable when you are making plans. Your next step is understanding the needs and expectations of interested parties, and these will be on your external list of issues. QMS scope is closely related to your defined purpose, strategic direction, and intended QMS results. Risks and opportunities for your QMS will be more easily identified from your list of positive and negative relevant issues. The list of requirements that are more easily addressed by using this issues list goes on and on.
- Occasionally review your information: It is no surprise that organizations change, so why would this information not change, too? Occasionally, it can be helpful to review this information for changes that might affect how your QMS is implemented and how your company operates. Are your purpose and strategic direction still the same? Do you expect different results from your QMS? Have the internal and external issues changed from when you first identified them? This might not need to happen monthly, or even yearly, but an occasional re-visiting of these foundational elements of the company and the QMS can be beneficial.
Not just a requirement – do it for yourself
It is important to note that the AS9100 requirements do not require any documented information in terms of procedures or records for this process, and some companies will not want to do more than is required to be compliant. However, if you are putting in the effort to properly identify what issues are out there that affect your QMS, it is in your best interest to ensure that you retain this list, as it might change and adapt over time. If you make the information useful and relevant to you, it will make sense to maintain this important insight into your company and how it fits within the world.
Find out more about AS9100 with this informative article: What is AS9100?
