Why is ISO 9001 important?

In a previous blog post I talked about only selecting contract manufacturers who have ISO 9001. So, I wanted to explain a little bit more about why this is so important and what being ISO certified actually means. Then, watch for an upcoming post where I go over some of the other certifications that might be relevant to your specific product.

ISO 9001 is a process based standard for a Quality Management System. It isn’t a standard for how products are made - which is why it is so versatile and can apply to pretty much any manufacturing industry. It is basically a standard that controls how you do your internal processes so that the product produced meets the quality targets.

This is so important because the standard is basically a methodology to root cause issues, document them and then improve the issues. And trust me, there are always issues in manufacturing! It’s a LENGTHY process to become ISO certified, sometimes up to 18 months, so a manufacturer doesn’t embark on this certification lightly.

So, what is really the point of getting ISO 9001 certified? A manufacturer can develop their own QMS and be fine right? Well, the reason ISO 9001 is so wide spread is because it’s a very comprehensive and well thought out QMS. Why not take advantage of decades of refinement and implement those same standards that have led other companies to success as well? Not to mention, the certification is globally recognized and is a great selling point because customers know that the manufacturer takes their quality seriously.

One of the principles of the ISO methodology is identifying upfront what the customer is looking for and what makes the part or product perform to their specifications. There is quite a bit of time spent reviewing the specification to ensure that the machinery and process is capable of meeting the specs, and that the parameters are set in such a way that the specs can be met. So the idea is that you do as much as you possibly can up front to avoid issues.

But as you know issues always pop up. There are more than enough things that are unpredictable and hard to anticipate. Therefore, when there is a manufacturing defect, or an assembly issue, or a cycle time that isn’t up to par, the ISO standard is set up to catch it as soon as possible and prevent non-conforming parts from going out the door.

Ultimately, it is a culture of continuous improvement. They don’t sweep things under the rug, they don’t turn a blind eye. They acknowledge it, root cause the issue and then address it and try to prevent it from happening in the future. It is very rare that I would ever consider sourcing a product to a manufacturer that is not ISO certified. More often than not, I don’t even talk to manufacturers that aren’t certified. When you have your pick of hundreds of companies who are certified why would you risk placing your product with someone who isn’t?

Now that you have the basics of standard certifications stay tuned for next week’s blog post about industry specific certifications that you might want to watch out for.