Understanding ISO 9001 Clause 7.5.1 General (Documented information)

ISO 9001:2015 Clause 7.5.1 (General)

Hello today. I am going to cover clause 7 51 general, which doesn't tell us a lot. Um, with regards to documented information, what I'm sharing with you is the clause statement from. 9,001, ISO 9,001. And you'll see it's 7.5 documented information. And it's just this general clause. You will have found if you've gotten this far through the standard already, that there's quite a few clauses that do have at the commencement of each like sub clause, a general cause.

And it really just gives us an idea of what it's about. What's coming up essentially. This one. Is a little bit different. I think it's really a really important cause because it explains to us in a little bit more detail, the requirements for documented information that are mandatory and then anything else, any other documented information that we require.

So I'll explain it to you. So it says the organization's quality management system shall. A documented information required by this international standard. Okay. Pretty straightforward. So wherever you have seen in ISO 9,001, where it states that documented information is to be retained or maintained or be available, well, you have to do.

Okay. It's spelled out for you in the standard. There's quite a few, um, clauses throughout that required documented information. So this is just simply saying, well, if it says that you need documented information in a clause, well, you shall include it. Okay. It's a requirement. Now it goes on to B where it says.

Documented information determined by the organization as being necessary for the effectiveness of the quality management system. I'll say it again, emphasizing different words. So it says documented information determined by the organization as being necessary for the effectiveness of the quality management system.

Right. So this clause is saying, well, one, you need to have what we say. You have to have documented. That's a, but then in B it says, well, if you. belief that documented information will support your system to ensure that your quality management system is effective. Well, then you will have it as well. You will create it, you can create it.

So if we are looking at this from the perspective of say, um, a hierarchy of control, we all know documentation is. Part of the hierarchy of control. It's a lower level control, but to. Maintain consistency, maintain consistency of output. And in particular, this is quality. So this is about the output and the service that we provide to our customers.

We want that consistent output don't we? So there might be some clauses within the standard where it doesn't specifically say. You shall maintain documented information or you shall retain documented information, but that doesn't mean you can't have it. Okay. If you think it will support your system, if you think, oh, we need to have this procedure, um, documented so people can follow it.

Or we might need a checklist here to ensure that everyone that touches this process. Does and follows the same steps. Well, then you do it. Okay. This is all about making your system more Sol like solid. Okay. Mature. Robust is probably the better word. Okay. Now some of you might think, oh, well, if it doesn't say I have to have documentation, well, I'm not doing it well, that's fair enough.

that? That's, that's your choice. However, I will point out that. What you might find is that those are the steps in your process or the areas in your system that you might end up with nonconformances you might end up with, um, customer complaints or feedback. Okay. So it will come around full cycle. Right?

So if you. Missed an area that may benefit from documented information being retained or maintained, then you might come full circle if there is a nonconformance or a complaint, and you might decide at that point. Yeah. You know what. This might be more manageable if we have a procedure or if we have a checklist.

All right. So that's sort of the mindset that you need for B now to finish off, there is a note at the end of clause, 7 51, and the note says the extent of documented information for a quality management system can differ from one organiz. To another, due to the size of the organization, it's type of activities, processes, products, and services, the complexity of processes and their interactions and the competence of persons.

Okay. So this is really important to understand. There will be a different level of documentation depending on the size of the business. All right. So if we are talking an international or global business with tens of thousands of employees scattered all over the world, We would tend to expect much more documentation.

Okay. Cuz there's, there's a lot more to try to control and manage as compared to a family business that has one, one location. And it's just say the husband and husband and wife. Running the business. They would have far less documentation requirements because they would be working together and the communication would be on the go and verbal.

Okay. I'm not saying that they wouldn't benefit from having some additional areas as per B documented, however, They, we would expect for them to have less areas documented than an international global company. So that's that size of the business. And of course, if it's a, a complex or a high risk product or service that you deliver, again, you would tend to have a lot more documentation.

Because as I mentioned before, This is a control, essentially. Okay. So more complex or higher risk products and services will tend to have more documentation than a lower risk product or service. All right. I hope that helps you and have fun with documented information. Thank you.