Folders & Organizing Your QMS
Documents & Records Published on May 25, 2026

Folders & Organizing Your QMS

Managing document and record folders and ISO 13485 best practices.

I never thought I'd be writing an article about folders, but I guess you never know, right? So here's how Formwork's folders work.

It's pretty much like folders on your computer:
  • Folders can have subfolders.
  • You can even drag and drop stuff between folders!
  • There's a handy menu on the left side which shows you an overview over the current folders.

One important note: You can't move documents to records folders and vice versa. That would end up being an epic mess. So document folders (and their subfolders) can only store documents, and records folders can only store records.

Document Folders

Things will get more obvious when we look at a picture, so here's how document folders look like:
Document folders in Formwork.

On the left side, you can see the handy submenu which shows you the contents (including subfolders) of the current folder. In this case, we've selected the "root" document folder (which is aptly named "Documents").

So the contents you see on the left side mirror the contents you see in the center section.

Record Folders

Here's how it looks for records:
Record folders in Formwork.

No real surprises there.

I guess I don't have to go into more detail into how folders work, you know all of that already.

How about some best practices on how to create a structure for medical device QMS documentation?

QMS Folder Structure Best Practices

Of course it's entirely up to you how to set up your document and record folders in your QMS in Formwork. Still, I thought I'd share how we do this, which has pretty much become the standard setup in our consulting which has been going on for 6+ years:

Documents
  • SOPs folder for, you guessed it, SOPs
  • Templates folder for templates

Records
  • We tend to give each SOP a unique prefix. For example, the Computerized System Validation SOP (which itself is located in Documents/SOPs) would get the prefix "CSV". And then, in the Records section, we'd create a folder named "(CSV) Computerized System Validation". So all records which would be "outputs" of the CSV SOP would end up there; in this case, these would be records containing validation documentation of software we'd be using in our QMS (one of the borderline useless requirements of the ISO 13485, by the way).

Good luck setting up your folders!