In this article, I’m going to cover the first few elements of clause 7.1 Resources. I’m going to unpack the clauses:
These all work together so I thought I’d cover them all together.
Ok, let’s get started on the first clause 7.1.1 General for ISO 9001. I know – what on earth does General mean? As I’ve mentioned in other videos these General clauses are always at the beginning of a new section and they explain ‘generally’ what the requirements are. They specify what the overall intent and requirements are and then the supporting clauses get into a bit more detail. I’ll break down this general clause and you’ll see what I mean.
Clause 7.1.1 General states that:
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance, and continual improvement of the quality management system.
The organization shall consider:
a) the capabilities of, and constraints on, existing internal resources;
b) what needs to be obtained from external providers.
This is simply saying that the organization needs to ensure that there are sufficient resources (which could be people, equipment, software, hardware, and so on) to not only get the quality management system up and running but to maintain it and improve it long term.
When the organization reviews what resources they need they will look to see what is available internally – so what they already have within the business and if there are gaps, then they need to source what’s needed externally from other providers or suppliers.
You can see this is a simple overarching statement of what is expected from the organization to resource their quality management system. The following clauses break down the different types of resources to consider and provide.
This leads nicely to Clause 7.1.2 People, which states that:
The organization shall determine and provide the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes.
That’s it – short and to the point. You can see how this single statement supports the General clause and actually kind of repeats itself. The only addition to what we already know is that the provision of people as resources is for the quality management system implementation as well as the operation and control of its processes. The business needs to have enough competent people to ensure that the quality management system and its operations are effective. Competency is touched on in clause 7.2, so be sure to check that video out for more details on what that will look like in your system.
Then we move to Clause 7.1.3 Infrastructure which states that:
The organization shall determine, provide and maintain the infrastructure necessary for the operation of its processes and to achieve conformity of products and services.
Again – short and to the point. This time it’s about the organization figuring out what infrastructure is needed to ensure that what they do or plan to do is achieved – all around providing their product or service to their customer of course.
So, what are they referring to when they talk about infrastructure? Luckily we don’t have to look too far, because ISO 9001 has added a lovely little note at the end of this clause which tells us!
It states that Infrastructure can include:
- a) buildings and associated utilities
- b) equipment, including hardware and software
- c) transportation resources
- d) information and communication technology
That’s pretty straightforward, isn’t it? So, if you are implementing a quality management system you not only have to consider the resource of your people, but it should also be the tools, equipment, hardware, software, and communications tools that you provide for them to use to ensure that the customers’ requirements can be met.
The final clause in this section is 7.1.4 Environment for the operation of processes which states that:
The organization shall determine, provide and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services.
This time around it’s about the organization figuring out what is needed in the environment that your people are working in to ensure that what they do or plan to do is achieved – providing their product or service to the customer of course. So, again what are they referring to when they talk about the ‘environment’? Luckily, once again ISO 9001 has added another NOTE at the end of this clause which tells us what ‘environment’ could be. It states that
A suitable environment can be a combination of human and physical factors, such as:
- a) social (e.g., non-discriminatory, calm, non-confrontational)
- b) psychological (e.g. stress-reducing, burnout prevention, emotionally protective)
- c) physical (e.g. temperature, heat, humidity, light, airflow, hygiene, noise)
These factors can differ substantially depending on the products and service provided.
So, while the earlier clause referring to infrastructure was about things that you could ‘see or kick’, this clause referring to the environment is more about the things that aren’t so physically visible. Ensure that your people work in an environment that supports them socially, psychologically, and physically ensures that your people work for an organization where they operate at their very best, and that can only benefit YOUR customers and the delivery of your products and services.
So, to wrap all of these clauses up, it’s important to note that when you determine what resources you need to establish your quality management system and effectively operate and control your processes you need to consider 3 things:
These all add up to ensuring the best possible outcome for your customer and the quality of the product or service you are delivering.
My big question to end on this group of clauses is What is an auditor looking for then? Personally, when I conduct an audit, I see all of this throughout the audit interviews. While talking to different employees, contractors or managers I will see whether:
Overall, it’s about the work environment as a whole. So, you can see that this is all about observation throughout the audit. There normally isn’t a lot of documented evidence here. Unless in meeting minutes it is recorded that more resources are needed and the action is recorded – which actually reminds me that in clause 9.3 Management review they do talk about reviewing the adequacy of resources, so that simple requirement in clause 9.3 really backs all of this up further.
Now that I’ve explained all of these requirements, can you see more clearly how you could action and demonstrate these requirements in your organization and ISO 9001 management system?