Posted on 07/14/2026 | By Jeff Daro On May 6, 2026, we finally completed our AS9100 certification process. A short time after on May 25, 2026, we also got our ISO 13485:2016 certification done. What is the difference between ISO 9001 and AS9100? The AS9100 standard is the ISO 9001 standard with a few more requirements bolted on to it by the International Aerospace Quality Group (IAQG). The purpose of these extra requirements seems to be to focus a quality management system (QMS) towards the aerospace and defense industries. What this means in practice is that there are more defined controls regarding quality, documentation, and traceability of parts as they flow though our shop. For example, clause 5.1.2 says: “Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring that: a. customer and applicable statutory and regulatory requirements are determined, understood, and consistently met; b. the risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed; c. the focus on enhancing customer satisfaction is maintained; d. product and service conformity and on-time delivery performance are measured and appropriate action is taken if planned results are not, or will not be, achieved.” The bold text is what was added to the original ISO 9001 standard. It’s adding specificity to what was once a very generic requirement. What is the difference between ISO 9001 and ISO 13485 ISO 13485 was written to cater to the specific needs of the medical device manufacturing industry. There are a bunch of new requirements for tracking lots, validation of processes, recalls, and even reporting to relevant authorities like the FDA. It makes sense. You’d probably want to have a traceable record of anything that is going to be used in and on a human body. Quality failures could be devastating. Why we got certified for both The extra requirements were still things we were mostly doing already, so we decided to go for it. Also, having both AS9100 and ISO 13485 certs shows that our QMS is really up to the task for any industries where poor quality and defective parts can lead to catastrophic failures. When potential customers come to us with parts that they need manufactured, we wanted them to be certain that it will be made to their exact specifications, delivered on-time, and be traceable. How this affects our current customers As with our ISO 9001 certification, again it’s not very much. We were already doing quite a bit of what was required by the AS9100 and ISO 13485 standards, so it’s nice to know that our QMS is even good enough for aerospace, defense, and medical device industries. We will continue making the quality parts and assemblies our customers have come to rely on us for. Now, there will be slightly more traceability in their production. To get a bigger overview of our QMS, take a look at our improved quality manual. Check out our AS9100 and ISO 13485 certificates by clicking here.
