Flowcharts For ISO 13485: Should We Add Flowcharts To SOPs?


We're starting to document our processes for ISO 13485 compliance. For that, we're using the OpenRegulatory SOP templates. However, we're also wondering whether we should add flowcharts to those because other consultants told us so. So - should we add flowcharts?

Short Answer


Long Answer

Look, I get it, flowcharts in SOP documents look great and are actually more readable than the actual document. Like, if you’re trying to show someone how your customer compliant handling process works, it’s probably easier to explain that process by showing them a flowchart than reading through a document which describes each step “in text”.

However! Flowcharts have huge drawbacks, and I think those drawbacks are so significant that I generally advise against them.

They take longer to update. Updating text in a document, e.g. if you’re using our QMS software Formwork, can literally be done in seconds. In flowcharts? Not so much. First, you have to open the flowchart. Then you have to click and drag things around. Next, you get lost in the options at least once because each box can be displayed differently (rounded corners or sharp corners?). Finally, you save it and, depending on how you store your documents, you actually have to export the image file from your flowchart program and re-import it into your eQMS document editor. Very painful. But most importantly, too slow for a startup.

Version control is not possible. If you’re a software developer and know git, you probably already know what I’m getting at: For text-based documents, version control is reasonably easy. You can display the old version side-by-side with the new document version, and if you use smart eQMS software (cough, Formwork), that software can highlight the changes in red and green. Cool.
For flowcharts, this is not possible. At most, you’ll be able to see that the flowchart image got swapped out, but you don’t know what in the flowchart changed. You likely have to hunt down the person who changed it at the time or “manually diff it” in your head by comparing each image side-by-side. Pain.

Not everyone can edit them. Everyone is capable of editing a text document. With flowcharts, it’s likely that there’s only one “internal Jedi Master” in the company, namely the person who created all flowcharts in the past. Other people likely aren’t sure how to use the tools for creating and editing them (if they have access to them at all).

They’re just damn slow. If you’re a startup and optimising for speed, flowcharts are not for you. You can try this out by yourself: It takes much longer to create a flowchart than to copy-paste one of our text templates.

Auditor’s Opinions On Flowcharts

What do auditors think about flowcharts?

Generally speaking, auditors like seeing flowcharts because they generally seem to like it when people spend way too much time on quality management documentation instead of actually building their product. Maybe that’s why medical device manufacturers get so little done.

That being said, auditors also accept text documentation. And even more than that, I’ve never heard of an auditor explicitly requiring flowcharts. That makes sense, because the ISO 13485 and other quality management standards simply don’t require them.

It’s up to you how to document your processes.

So don’t use flowcharts.

On a slighty different note: You want to get your medical software certified under MDR but don’t know where to start? No worries! That’s why we built the Wizard. It’s a self-guided video course which helps you create your documentation yourself. No prior knowledge required. You should check it out.

Or, if you’re looking for the most awesome (in our opinion) eQMS software to manage your documentation, look no further. We’ve built Formwork, and it even has a free version!

If you’re looking for human help, did you know that we also provide consulting? We’re a small company, so we can’t take on everyone – but maybe we have time for your project? We guide startups from start to finish in their medical device compliance.


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