Yes. One of four for this stupidly complex clause of the standard. Why there are so many requirements and so much baggage is beyond me. Don’t get me wrong. Design is one of THE most very important aspects of products and service. But it is left up to experts, qualified persons, deep thinking propeller hatted academics that need to be meticulous to keep people and property safe and functioning for the planned duration. So why have so much prescription in the standard? There are just so many important things to business, to customer focus, to continuous improvement that are glibly single sentenced in the standard. Why not this one? Oh well, my rant is nearly done.
The good news you can get an exclusion. The bad news if you do design, you can’t get an exclusion. So the proof is in the core business activities and what you are contracted to do. Nine out of ten times, you are doing ‘development’. And I say development, I mean modifying known models within know parameters to suit an application. If you are doing this, then I would recommend an exclusion. Anything more, then it is the full bottle and the next few weeks will either enthral or you bore you. Let’s find out together.
The seven topics we will cover in the three remaining blogs are;
Design and development planning; Design and development inputs; Design and development outputs; Design and development verification; Design and development validation; and Control of design and development changes.
And on reflection, this stuff should really only apply to 5% of all companies seeking certification. So for the rest of you, hold on tight.
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