So your company works in a regulated industry (like medical devices, what we specialize in) and you have to set up a Quality Management System (QMS) for compliance reasons. Great. And now you’re looking for QMS software so that you can get it done more efficiently. I often get asked whether there’s any free QMS software out there.

The short answer is “yes”, and the longer answer however is “it’s not necessarily great”.

But before I spoil any further content of this highly interesting topic (I think we all agree that QMS software is slightly more exciting than sliced bread), let’s look at our options and how they compare.

Before we get into those, here are the main three requirements which QMS software has to fulfil:

• Store documents (and old versions of them!) and perform electronic signing.
• Store structured data like design inputs and software requirements and link them with other things, e.g. system tests.
• Everything is easily exportable for handing it in to your auditors.

With those requirements in mind, let’s finally look at our options! You might have guessed the first one.

Google Drive And Microsoft SharePoint As Free QMS Software

Many startups use Google Workspace for their emails and calendars; and some weird startups use the Microsoft tools, which seem significantly worse and full of bugs, but.. where was I. Ah, you can use those as QMS software, too.

Google Workspace comes with Google Drive, and the Microsoft thing comes with SharePoint, which is like a terrible and buggy copy of Google Drive. Both of those tools fulfil the basic requirements of QMS software: You can manage and store your documents and old document versions in them, and you can do some sort of electronic signing with crappy third-party plugins.

Also, you can enter requirements in a structured way by e.g. setting up a Google Sheet. Linking entries in those sheets with entries in other sheets (e.g. linking design inputs to system tests) is not pretty and commonly ends up becoming a huge mess, but it works, kind of.

While these tools cost money, SharePoint and Google Drive feel like they’re essentially free, because companies already have access to them and they’re typically not purchased specifically to serve as QMS software.

Check out my article on how to set up a QMS in Google Drive, and here’s the article on setting up a SharePoint QMS.

GitHub and GitLab As Free QMS Software: Leveraging Code Repositories for QMS

Now, let’s talk about using GitHub and GitLab as QMS platforms. These tools, traditionally used for code repository management, offer unique advantages for managing quality documentation and processes.

While using GitHub or GitLab as QMS software might sound enticing, we’ve actually decided that it’s no longer a great choice - and we’ve tried hard, believe me! Many of our clients used it, and all of those setups ended up being really crappy. Read more here. Still, let’s look at them one by one. Here’s how they measure up:

GitHub As Free QMS Software

GitHub, a popular choice for software development, also lends itself well to QMS due to its robust version control capabilities. You can use GitHub repositories to store and manage your quality documents, keeping track of changes and maintaining a comprehensive history of revisions. This is crucial for demonstrating compliance during audits.

However, the challenge with GitHub lies in its steep learning curve, especially for non-technical team members. It requires familiarity with Git commands and Markdown for document creation, which can be a barrier. Nevertheless, for tech-savvy teams, GitHub offers an accessible and powerful tool to align their development and quality processes.

GitLab As Free QMS Software

GitLab, similar to GitHub, also offers powerful tools for QMS. It has the added advantage of integrated CI/CD pipelines, which can be leveraged for automating parts of the QMS process, like automatic document generation or compliance checks.

The same challenges present in GitHub apply to GitLab - it’s more suited for teams with technical prowess. Yet, its integrated approach can make it an efficient tool for companies looking to closely align their development and QMS processes.

If you still want to set up your QMS in GitHub / GitLab, check out this article on how to do it.

Nextcloud: A Self-Hosted Document Management Solution

Nextcloud offers an interesting proposition for organizations seeking more control over their QMS infrastructure. It’s a self-hosted solution that functions much like Google Drive or Microsoft SharePoint, allowing for file storage, sharing, and collaboration.

Features and Benefits

• Data Control: Being self-hosted, Nextcloud gives you complete control over your data, a significant advantage for companies concerned about data security and privacy.
• Customizable: You can extend its capabilities with various plugins and integrations, tailoring it to fit your QMS needs more closely.
• Collaboration: Nextcloud supports document editing and collaboration, which can be handy for team-based document management.

Challenges

• Technical Expertise Required: Setting up and maintaining a self-hosted solution like Nextcloud demands a fair bit of technical knowledge. This can be a barrier for organizations without dedicated IT support.
• Maintenance and Upkeep: Unlike cloud-based services, you’re responsible for server maintenance, backups, updates, and security, which can add to the operational complexity.

Redmine: An Open-Source Project Management Tool

Redmine is another self-hosted option, primarily known as a project management tool. It’s versatile and can be adapted for use as a QMS, particularly in managing requirements and tracking project progress.

Features and Benefits

• Customization: Redmine allows for significant customization, enabling you to tailor it to your specific QMS needs.
• Issue Tracking: Its robust issue tracking system can be leveraged for managing QMS tasks and requirements.
• Community Support: Being open-source, it has a community of users and developers, which can be a valuable resource for troubleshooting and enhancements.

Challenges

• Setup and Maintenance: Like Nextcloud, Redmine requires a self-hosted setup. This means dealing with server management, software updates, and data backups.
• Learning Curve: Redmine’s interface and features might require some time to learn, especially for those not familiar with project management tools.

Considerations for Free QMS Software

While free and open-source tools offer cost savings, there are trade-offs to consider:

1. Learning Curve: Tools like GitHub and GitLab require technical skills, which may necessitate training for non-technical team members.
2. Customization and Integration: These tools may require additional setup or customization to fully meet QMS requirements. This might involve scripting, integrating third-party tools, or even developing custom solutions.
3. Support and Reliability: Unlike paid QMS solutions, free tools may lack dedicated support, and their reliability can vary.
4. Exportability for Audits: Ensuring that documents and records are easily exportable in a format acceptable for regulatory audits is crucial. This often requires additional effort with free tools.

In conclusion, the choice of QMS software, whether it’s a simple, user-friendly option like Google Drive or a more complex, self-hosted solution like Nextcloud or Redmine, should align with your organization’s capabilities and compliance requirements. Remember, the goal is to support your quality management processes efficiently and effectively, keeping in mind the ease of use, maintenance, and audit requirements.