Why the Design Clause Shouldn’t Be Optional in ISO 9001 Implementation

If you’ve ever worked on implementing ISO 9001, you’ve probably encountered this question: Is the design clause applicable to our Quality Management System? For manufacturers, the answer is usually obvious. But for service-based organizations, it’s not always so clear.

Take a delivery service company, for example. At first glance, it might seem that design doesn’t apply—they aren’t producing a tangible product. But look deeper. These companies optimize routes, test packaging solutions, and continuously refine their logistics processes. Isn’t that, in essence, design?

If you do consider it design, then how do you approach inputs, controls, verification/validation, outputs, and managing changes? I’ve seen design controls applied to such service processes, with clear evidence of verification and validation. But is that the best way to implement the QMS—or are we stretching the intent of the clause?

Many consultants choose to exclude the design clause altogether and focus solely on service provision. Even then, key elements of the design process remain: identifying inputs, meeting legal and customer requirements, validating performance through feedback, and making improvements. Whether we call it “design” or not, the process is there.

In fact, I’d argue that even a build-to-print operation engages in design—design of the process. They may not design the final product, but they certainly design how to build it, validate special processes, and continuously improve their workflows.

If I were to rewrite ISO 9001, I wouldn’t separate design from the planning and realization of products and services. Design is intrinsic to every business. It’s what sets us apart—and it’s the foundation of continuous improvement.

Design isn’t just about products. It’s about thinking, planning, and building better ways to serve.
What do you think? Is the design clause more relevant to services than we give it credit for?

At Aumozition, we don’t just help you meet ISO 9001 requirements—we help you design systems that truly work for your business.

Whether you’re in manufacturing or the service sector, we understand that design thinking is at the heart of building effective, tailored management systems. From internal audits to ongoing system coordination, we ensure your processes aren’t just compliant—they’re intentionally crafted, continuously improved, and built to deliver value.

Because at the end of the day, it’s not just about ticking boxes—it’s about designing smarter ways to work.

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