Explaining ISO 9001 Clause 4.4 Quality Management System

In this article, I’m going to cover Clause 4.4 Quality management system and its processes. I’m going to break this clause down and turn it into something you can all understand. You’ll then be able to apply this to your own organization's system and understand what the requirements will look like for you.

No more guessing!

Ok, let’s get started! Clause 4.4 is called Quality management system and its processes and in this article, I am going to talk about each section of this clause and what they actually mean.

The first point in the leading sentence is:

The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions, in accordance with the requirements of this International Standard.

The organization shall determine the processes needed for the quality management system and their application throughout the organization.

The requirement here is that you/the business simply establish the quality management system and all of the associated processes, which could be documented or not, that are needed to meet the requirements of this standard and that it is up to the organization – you/the business to determine what these processes are and how they are applied within the business. That’s why I always say with this clause – if you are meeting all of the other requirements in the standard then you should be meeting this one.    

Now, there is one word in here that does stand out and is important to understand – that word is ‘interaction’. This clause mentions ‘the processes needed and their interactions’. When I see that word, I instantly think of the process approach.

There’s always an element of interaction between different processes which you can attribute to inputs and outputs. So, one process's output is another's input.

The first two points in this clause state ….

The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:

a) determine the inputs required and the outputs expected from these processes and

b) determine the sequence and interaction of these processes

Interesting – I always take a step back first before I explain what this is talking about.  Some of you might remember this in some businesses you’ve worked for or some of you might work in a business that still has what we call silos. I can hear some of you screaming in fear already. I’ve worked in businesses with silos as well and it’s frustrating, to say the least. When a business operates in Silos, one department is not aware of how its outputs impact the inputs of the next department. They probably don’t care. They are only concerned with their own department's requirements and tend to hold on to information and not consider the overall impact on the customer or the next department in the chain of processes. The customer is the vision that we want here – after all, with quality that’s what the key focus is.

So, now let’s spin this around and look at what clause 4.4 wants us to do again - Determine the inputs required and the outputs expected from these processes and Determine the sequence and interaction of these processes.  

Ok, this is the Process Approach – one of the Quality Principles which is all about a consistent and predictable result achieved more effectively and efficiently when activities are understood and managed as interrelated processes functioning in an organized manner.

Let's look at inputs and outputs and see what examples we can come up with.  Let's start from the beginning – what does a Sales team need to be able to communicate products to their customers?
They need to understand what the product is, how much it is, what it does, when it’s available, what colour it is, what colour it can come in, and so on. 

All of those things are an output from a product development team and even a marketing team and input into the sales team. The Sales team cannot do their job effectively without this information. If they did try to sell without this information, knowing Sales teams, I’m sure they would still sell something but would it be what the customer wants or more importantly what the business can deliver to the customer? You can see how important this is to get working within your business.

The requirement for the sequence and interaction feeds nicely into the process approach as well. You need to understand what the flow is for outputs into inputs – so what work or output is required before another department or person can do their job or the next step?
As a trainer, I need to have the course material, to create the course material, we need to understand what the performance criteria are, as well as what our students require and so on.  This cannot be done out of sequence.

How does this work in your organization?  Do you work in silos or do you follow the process approach? 

Right – I am wrapping up all of the last sections of this clause together now because … you know why? All of it is already covered somewhere else in the Standard – in other clauses. This is a ‘repeat’!

As I mentioned earlier – if you are meeting all of the other requirements in the standard then you should be meeting clause 4.4. So, don’t overthink it. The power of these standards and the knowledge you gain is understanding where the links are between the clauses – this way you only need to do one thing and it knocks off several requirements. Remember – work smart, not hard!

Now let me go through this list and show you where else you will find the requirements to implement in the Standard! Remember do it once!

Let’s look at

c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes.

Take a look at Clause 9.1.1 General which sits under clause 9.1 Monitoring, measurement, analysis and evaluation. All that you need is there!

Then we can move on to

d) determine the resources needed for these processes and ensure their availability.

Clause 7.1 is all about Resources – it includes people, infrastructure, the operational environment, equipment calibration, and organizational knowledge. Once you’ve worked your way through clause 7.1 and meet the requirements then of course you also meet requirement d) in clause 4.4. Do one thing and meet many requirements!

Back at clause 4.4 e) we have the requirement that states

assign the responsibilities and authorities for these processes

which aligns nicely with Clause 5.3 Organizational roles, responsibilities and authorities. It states right there in Clause 5.3 that responsibilities and authorities are to be assigned. This is too easy – right?

It is even easier when we get to ...

f) address the risks and opportunities as determined in accordance with the requirements of 6.1

This part of the clause even gives us the other clause number that we need to address the requirements of. Clause 6.1 Actions to address risks and opportunities. The standard is spelling it out very clearly!

Then we have

g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results.

The word that stands out to me here is ‘evaluate’ and I know that clause 9.1.3 is Analysis and evaluation. Again, understand and implement the requirements of this linked clause and you’ve met clause 4.4 requirements.

Now finally in this list of linked requirements there is ...

h) improve the processes and the quality management system 

We have an entire clause in the standard called Improvement – this is clause 10, so why not refer to clause 10, understand it, and implement it  - just like that you are also meeting 4.4 h) requirements!

See how easy it is when you understand all of these links within the standard? I love it and I love it even more when I see you all take this on board and apply it within your management systems.

Now, there is one final subclause here – clause 4.4.2 and this is all about maintaining and retaining documented information to support the operation of processes and to have confidence that the processes are being carried out as planned.

When you explore the linked clauses above that I have shared with you within the standard, you will see that within them there are already requirements for documented information. Apply these requirements and you again automatically meet this requirement. Don’t think that you have to create a whole separate set of documents to meet clause 4.4.2 requirements – no, stop! Just familiarise yourself with the linked clauses, establish and maintain the documented information requirements and you’re done. That’s working smart, not hard!

See how simple this is when you break it down? There’s really nothing to be scared of with these standards or the clause requirements. If you do have questions regarding this section of clause 4.4 or you would like me to cover another clause please comment below and I’m only too happy to help. I love talking about this stuff!

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