What is ISO 9001:2015 Clause 4.2 all about and how does it effect your business?
In this article, we have a video where Jackie breaks down Clause 4.2 Understanding the needs and expectations of interested parties, and turns it into something we can all understand. You will be then able to apply this to your own organization's system and understand what the requirements will look like for your business.
No more guessing or confusion!
Clause 4.2 is called Understanding the needs and expectations of interested parties. There are a couple of points in this clause, so I am going to break them down and explain them separately.
The first point, point a) states that The organization shall determine the interested parties that are relevant to the quality management system.
Before we can understand this fully, I think we need to take a step back and understand what an interested party is. I checked this in the Terms & Definitions in ISO 9000, which is the Standard that has all of the terms and definitions relevant to a quality management system. I found that this term is described by stating that an interested party is a person or organization that can affect, be affected by, or perceive itself to be affected by a decision or activity. An example is given of customers, owners, people in an organization, providers, bankers, regulators, unions, partners, or society that can include competitors or opposing pressure groups.
The concept of interested parties extends beyond a focus solely on the customer therefore it is important to consider all relevant interested parties. Part of the process for understanding the context of the organization is to identify its interested parties.
We need to ask ourselves that when we make a decision, a change, or introduce a new activity or product even – who might be impacted by this? A great tip for this is to separate who might be impacted either internally to the business or externally. This internal and external suggestion is not a mandatory requirement, but I find it helps me to think broadly. As an example, internally this could be employees, workers' representatives, the owners or shareholders of the business, or even the board of directors. Externally this could be suppliers, competitors, subcontractors, regulators, government bodies, customers, and even visitors to the workplace.
Identifying these interested parties is the first step which leads to the next point in this clause, point b) which states that The organization shall determine the requirements of these interested parties that are relevant to the quality management system. The relevant interested parties are those that provide a significant risk to the organization if their needs and expectations are not met. It is up to the organization to define what results are necessary to deliver to those relevant interested parties to reduce that risk.
This means that now we have identified who these internal and external interested parties are, we need to determine what they expect and need from us. I have actually seen this laid out quite nicely in an audit I conducted recently. This company simply uses an excel spreadsheet and on Worksheet 1 they have listed their Interested Parties, whether they are Internal or External, and then finally the reason for their inclusion – which I think is a great addition as it demonstrates their thought process. Then on Worksheet 2 they have extended from this list of just interested parties and added another column documenting each interested parties needs and expectations. So, for example, Employees expect and require relevant customer service training so that they can not only meet customer requirements but their own KPIs or targets. You can’t do this without the appropriate training, right? And as another example, your Customers expect that they receive what they ordered on time and within budget and that what they have received does the job intended. This seems a no-brainer expectation, but you’d be surprised!
You can see that this is a nice simple way of identifying, documenting, and then of course reviewing this requirement. Speaking of reviewing – the last sentence in this clause states that the organization shall monitor and review information about these interested parties and their relevant requirements. Of course! Now, this is the area that I wanted to share with you a ‘link’ to another clause in the Standard – remember – it’s about working smart, not hard. And the clause is ……… 9.1.1 The General clause under clause 9.1 Monitoring, measurement, analysis, and evaluation. This monitoring and review is a requirement under that clause – it says the organization shall determine a) what needs to be monitored and measured, the methods, and when it’s to occur.
Well, by the time you get to this requirement you already know at least one area, now don’t you? That’s right – straight from her, clause 4.2. You don’t need to re-think or re-do anything! You already know that this is a requirement. And remember that this is not a process we would do just once, it will be an ongoing process as the business changes, as activities change of course interested parties will change and so will their needs and expectations. You need to ensure that this is an ongoing process and is maintained and current.
I have only used a couple of examples here and when you go through this process within your own organization it will be so much clearer because you understand your own business.
If you take a helicopter view of this now, you will see that this process in itself has identified risks and opportunities for your business.
I love it when you can see it like this. It isn’t just a pointless exercise to tick a few boxes against a standard – this process actually benefits your organization.
It helps you to identify the risks so you can put in place controls or treatment plans.
It helps you to identify the opportunities out there and leverage them to be proactive in your quality management system. This is fantastic stuff – get excited about it!
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Now that I’ve explained all of these requirements, can you see more clearly how you could action and demonstrate these requirements in your ISO 9001 management system?