Clause 7 Explained | ISO 9001 Version 2015 Quality Management System | Clause 7.1 Explained | 9001
This video is about Clause 7 Explained. Element 7.1.3 requires 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.”
To explain the requirement, the standard provides examples of what may be part of the infrastructure:
• Buildings and associated utilities;
• Equipment, including hardware and software;
• Transportation, if you use it
• Information and communication technology and others
Once I audited a company and discussed maintenance, I asked my guide if they had a maintenance or inspection schedule for their heating and cooling systems. Before she could answer, the VP of quality intervened and asked what HVACs had to do with their QMS. A bit surprised, I had to refer her to clause 7 explained, specifically clause 7.1.3, and ask if they could produce their products without the heaters and coolers. I am still waiting for the reply, but I have a pretty good idea of what she could have answered. Like in this example, some companies do not include in their infrastructure all the systems necessary for the operations and to meet customer needs, but there is a straightforward test to find out if something is a part of your infrastructure. Ask an easy question: can we produce our products or deliver our services without THIS? Compressed air, backup generator, pest control service, forklifts, our friendly IT folks, and others. The answers are simple: Yes, we need all of these.
Now that we know what goes into infrastructure, the question is how we manage all these entities and pieces of equipment and services. There are a couple of approaches you may consider. On the sophisticated side, there are numerous software applications whose sole purpose is to manage the company’s equipment and schedule activities related to services. Often their names refer to asset management, equipment maintenance, facility management, and others. While these pieces of software are relatively inexpensive, some organizations still track their equipment on worksheets. If your company needs to use tables or wants to model the process before moving to a software app in the future, you may check our website for an Asset List Template.
To summarize, by now, we have covered three subclauses of element 7.1 of ISO 9001. In the following video, we will move to element 7.1.4, Environment for the operation of processes, which will take us closer to Clause 7 Explained.
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