ISO may seem like a complex solution, right? But it is in fact easier than many expect. In this blog, we will be talking about ISO 9001 Clause 4. However, if you are interested about other clauses within this standard I invite you to look at the other reading material or YouTube videos that go over the rest of the clauses.
Clause 4 of the ISO 9001 standard is a relatively new clause. In fact, it was introduced in 2015 and I think it was an excellent addition to this particular standard. The ISO 9001 Clause 4 talks about the context of the organization meaning that your organization doesn’t operate in a bubble.
ISO 9001 Clause 4.1
You don’t operate by yourself, you operate in a world, you operate in an industry, you operate in a market that is affected by internal and external issues. And effectively that is what ISO 9001 Clause 4 is all about. It tells us that the organization shall determine external and internal issues that are relevant to the purpose and its strategic direction and that affect its ability to achieve the intended results of its quality management system.
Let’s chunk this statement down into smaller elements. So first of all when talking about external and internal issues, the word issues doesn’t matter because these internal and external issues, these internal and external issues factors, can also be positive factors.
Therefore, here the standard is effectively asking us to consider negative or positive internal and external issues factors that could have an impact on our organization. The standard is telling us that the organization shall monitor and review information about these external and internal issues.
What this means is that effectively we need to do a SWOT analysis. We need to analyze the strengths, weaknesses, opportunities and threats relating to your organization. And how does a SWOT analysis help to meet the requirements of this particular clause? When doing a SWOT analysis, the strengths and weaknesses relate to the positive and negative factors that are internal to your organization. So strengths could relate to things that you do well within your organization.
For example, you have an experienced management team, you have a large portfolio of customers, products or suppliers, which is a strength within your organization. A weakness might be something negative that pertains to your specific industry, rather than pertaining to your specific organization.
And this might be for example, a large employee turnover, not having certain funds to make certain investments that are needed within your organization. Maybe you have the limited mindset of some people within management. So these are internal issues and in this case they are actually issues because they are problems or weaknesses within your organization.
Now when we are considering opportunities and threats, okay, these will be opportunities naturally will be positive external factors and threats will be negative external factors.
So examples of opportunities might be that there might be good funding opportunities from the government to implement certain management systems within your organization. Another opportunity might be that there is free information online, for example, this video on how you can implement ISO standards within your organization or other opportunities.
Weaknesses might be arising inflation, it might be rising interest rates, it might be not having enough people to effectively work within the industry that you are working within. So that would be labor shortage.
So these are things that are negative and that can affect your organization but that you don’t have direct control over. Naturally, the idea between going into this detail of doing the SWOT analysis to consider the internal and external positive and negative factors that could have an impact on your organization would be that we take some type of action relating to these elements.
However, you don’t need to do anything about these elements just yet in clause 4 .1 because these will be discussed later in clause 6 within the standard when we are talking about the risks and opportunities relating to your organization.
ISO 9001 Clause 4.2
Moving on to ISO 9001 Clause 4.2 within the ISO 9001 standard, the standard tells us that our aim must be understanding the needs and expectations of different parties. Once again a fantastic addition to the ISO 9001 standard whereby if as an organization, we only focus on the needs of our clients (given that this is a quality management system), then, the business is bound to fail because if, for example, we are not considering the needs of the shareholders, the needs of the employees, the needs of our suppliers, then that is not a sustainable business.
So what the standard is asking us to do over here is that due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine interested parties that are relevant to the quality management system and the requirements of these interested parties that are relevant to the management system.
So here, the standard is very clear on what we need to do. We need to make a list of all the interested parties that are relevant to your organization. In management school, you might call these stakeholders.
Looking Out for the Needs of Stakeholders
So all types of stakeholders, which might be employees, it might be the government, suppliers, clients of clients, it might be neighbours to your organization, or anyone who might have some type of impact on your quality management system. Then, for each one of these stakeholders or interested parties, we need to identify the needs and expectations for these types of stakeholders from our management system. The standard goes on to say that the organization shall monitor and review information about these interested parties and their relevant requirements.
What this means is that just like all other elements within this quality management system, we have to make sure that we are continuously updating and reviewing the needs and expectations of these different interested parties. After implementing the management system, we shouldn’t just let the requirements of clause 4 .2 slip by and say that they are met. We have to continually review and update. these, the needs and expectations of the interested parties relating to your organization.
ISO 9001 Clause 4.3
ISO 9001 Clause 4.3 talks about the scope of the quality management system and before delving deeper, I wanted to explain what we are referring to over here. So the scope of the management system relates to what will be actually written on your ISO 9001 certification. Here we are looking for a few words that will summarize what you do as an organization. For example, provision of accountants and services or plastic injection moulding for the automotive industry or it might be supply and delivery of medical devices.
So as you can see it will be a few words that encapsulate everything that you do as an organization. The standard, when it comes to ISO 9001 Clause 4.3, states that the organization shall determine the boundaries and applicability of the quality management system to establish its scope.
What this means is that if your organization, let’s say that your organization imports medical devices and computer equipment, you might want to say that your scope of certification is supply and delivery of medical devices, it might be supply and delivery of computer equipment, or it might be supply and delivery of medical devices and computer equipment.
As you can see, from these three different scopes, we are depicting a completely different type of organization from one another. One focuses on selling medical devices, the other focuses on selling electronic products, and the other says both medical devices and computer products.
This can be done when implementing a management system within your organization, where if you see that you need to implement the management system on one aspect of your organization, that can be done as is explained over here. When determining the scope, the organization shall consider the external and internal issues that have been mentioned in ISO 9001 Clause 4.1, the requirements of relevant interested parties referred to in clause 4 .2, and the products and services of the organization.
So naturally, as a company, you will, for example, get ISO certified because one of your clients is asking you to get certified. If one of your clients is asking you to get certified, then you will definitely include the selling of those specific products within the scope of certification.
However, if there are other elements within your organization that you would not want to consider, you can freely do that. And the organization shall apply all the requirements of this international standard if they are applicable within the requirement scope of the quality management system.