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Do You Need ISO 9001?

September 16, 2025

 by David Collins III

It is a silly title, I will admit, but it does capture a real question. Does ISO 9000 certification (or any of the other various ISOs) mean that a manufacturing produces quality products? Not necessarily. Is the certification required? Not always. This blog will help you understand what ISO is, what it is not, and help you decide if you need it or not.

What is ISO?

ISO stands for the International Organization for Standardization. ISO has over 25,000 international standards that cover everything from quality management, safety, IT security, manufacturing, country codes. If you can think of it, there is probably an ISO standard for it. ISO is useful because it provides a standard that is globally recognized. An ISO standard operation should be the same regardless of the country.

We will be focusing on ISO 9001 (quality management) on this blog. You can learn more about ISO 9001 on the official website. Companies often use ISO 9001 as major selling point and many buyers require ISO 9001 certification.

ISO 9001 does Not Necessarily Mean Quality

ISO 9001 is a great tool. Companies that have fully integrated their processes in their manufacturing often have high quality and better operations. However; like any tool, if it is misused or only used a certificate on the wall it is useless. Having ISO 9001 certification does not necessarily mean that a company follows its processes or produces good quality products. We have seen in China, and elsewhere, companies that certified but it is a paper exercise without the rigor to back it up.

As ISO 9001 is a requirement for getting new customers, companies will go through the motions to gain the certification and pass audits. It becomes more box to check than a tool to use.

Some of the common ways that ISO 9001 is misused:

  • Paperwork over practice. Perfect documentation that is not seen on the actual production floor. We see this one all the time.
  • Audit theater. The company carefully prepares the area that the auditor will see.
  • Letter of the Law. Companies set up the minimum to pass without any implementation.
  • Ignoring the Customer impact. Companies will keep logs of everything but will not actually use these logs to improve customer outcomes.

Without the right mindset, ISO 9001 is just a method for recording information and not for producing quality.

Should I or My Manufacturer be ISO Certified? 

If you or your manufacturer is going to use ISO to improve your operations, then absolutely. It is a great tool. If you don’t need it for your business and you have a robust quality system, then do not bother. Much like this classic scene from the 1994 classic Tommy Boy, just because you write have a label does not mean its good. Apologies for the language.

A successful quality program requires both clear process and dedication to use it to create quality products. I will give you a recent example. We are working with a company to reshore its operations to North America. Its products have very high tolerances and standards. A high-quality manufacturer was found. Our client was concerned because they did not have ISO certification. I spoke with the company owner, and he described their quality management system. It was solid. He told me that he did not get ISO certification because it was a lot of paperwork and did not add anything to our operations. A thorough assessment of his company’s quality program showed that they understand what a good quality management system should accomplish (high quality) so did not need certification for it. The extra paperwork would only get in the way.

What Should I or My Manufacturing Supplier Do? 

It depends on what you want to accomplish. If you are required to have ISO 9001 certification, then get it. If you need a good place to start for quality management, use it. By itself, ISO 9001 will not solve your quality problems. An audit will not fix bad quality from your own factory or a supplier. Make sure there is a process, and it is being used.

What makes a good quality management program is something that produces good quality consistently. ISO 9001 can be a great tool to build that system, but it is not the solution by itself. Create a system that works for you, your business, and your operations. We would be glad to help you figure that out.

 

 

 

 


What can MTG do to help you improve your operations?

 

Topics: Manufacturing Consulting, Manufacturing In China, Localized Expertise, reshoring considerations, financial

David Collins III

David Collins III

David Collins III is the CEO of Manufacturing Transformation Group. He has lead the company since 2021. Since that time, MTG has expanded from its original China focus to become a global company with operations in China, the US, South America, Vietnam, and Europe. He is an Iraq War (US Army) and Afghanistan War (State Dept) Veteran and a graduate of Johns Hopkins SAIS.

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