Should you use Microsoft software to build your own digital QMS?

SMEs creating a digital Quality Management System (QMS) often turn to familiar, digital tools to build a solution fast. But while using Microsoft software may seem the most cost-effective and straightforward approach, can it meet the compliance, scalability, and efficiency requirements of a robust QMS?

What does a Microsoft Quality Management System look like?

Microsoft QMS solutions range from stitching together word and excel files, to taking a more structured OneDrive for Business approach. Alternatively, it might entail a full-blown SharePoint project, or using one of the Microsoft 365 business packages to build out all the governance workflows required by ISO 13485, the FDA QMSR and GXP regulations. 

But can they really deliver on complex quality challenges in a way that makes commercial sense for an SME?

Can you just use Excel, Word, Outlook, and a shared drive?

The simplest DIY QMS approach to document control often starts with:

• Using Word or PowerPoint to document processes and procedures
• Storing files in shared folders accessible across the organisation
• Collecting internal and customer feedback via Outlook emails
• Managing document updates using tracked changes
• Locking documents for editing to prevent unauthorised modifications
• Using an Excel sheet to organise and link documents
• Tracking review and approval dates manually in Excel

Limitations

While this approach seems inexpensive and easy to implement, it introduces significant risks as document control complexity increases:

• Version control challenges – Multiple document drafts create confusion and errors
• Lack of structured review workflows – Email-based approvals are difficult to track and audit
• Broken links and misplaced files – Excel-based indexing quickly becomes unreliable as files are moved or renamed
• Manual compliance tracking – Regulatory requirements for traceability, approvals, and audit readiness become unmanageable

At smaller scales, this setup may seem adequate, but as organisations expand and regulatory scrutiny increases, inefficiencies, compliance risks, and administrative overhead can escalate.

Should you use OneDrive for Business?

OneDrive For Business is Microsoft’s commercial file-sharing and collaboration offering, which competes with the likes of Dropbox and Box for the business dollar. It’s a better option for a QMS than stitching together a solution with only the standard MS Office tools, but still not perfect.

• OneDrive is good for seamlessly sharing files with multiple colleagues across different devices and on the move.
• OneDrive can help you set up a controlled and searchable system of files to document your SOPs and other quality processes.
• Administrators and users with privileges can restrict and control access to that content within teams and organisations.
• OneDrive can share real-time notifications telling selected individuals whenever a file is viewed or edited.
• Documents in OneDrive do have a version history showing who has created or modified them and when - but this may not be enough for future auditors.
• Basic workflows can be set up in OneDrive so that documents can be reviewed and approved in a particular, repeatable order.

Clearly, many of these features would be useful (and are a fundamental requirement) for a Quality Management System. But when you compare them to the quality standards for medical devices specified by ISO 13485:2016 or demanded by a regulations (like the FDA QMSR) the controls over documentation that OneDrive offers begin to seem pretty weak.

Here, for example, is the FDA’s requirements for a change control procedure:

“Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.”

While automation tools like Power Automate can enhance OneDrive’s capabilities, building a fully functional QMS with version control, audit trails, and FDA-compliant e-signatures still requires a lot of technical expertise and additional workarounds.

Should you use SharePoint?

For organisations seeking greater control over document management, SharePoint often becomes the next logical step. Its flexibility allows for extensive customisation to meet compliance needs.

Advantages

• Centralised document repositories with granular access controls
• Custom metadata for efficient indexing and retrieval
• Configurable workflows for document review, approval, and retention
• Integration with Microsoft Power Automate for business process automation

Challenges

• High customisation requirements – Deploying a compliance-ready QMS in SharePoint typically requires IT expertise or external consultants
• Ongoing maintenance burden – Custom workflows must be continuously managed to remain effective
• Scaling limitations – As quality management processes evolve, SharePoint’s rigid structures can become difficult to modify
• Significant licensing costs – Enterprise-tier plans are required for advanced compliance features, increasing long-term expenses

While SharePoint can be configured to support QMS functions, its resource demands often divert attention from core business objectives, making it a costly and complex solution.

Should you use Microsoft 365 for Business to build your QMS?

Microsoft 365’s enterprise solutions offer integrated collaboration and workflow automation capabilities, making them an attractive option for organisations seeking a connected digital workplace The Microsoft 365 E3 package includes:

• Excel,
• Word
• OneNote
• PowerPoint
• Teams
• Outlook
• SharePoint
• OneDrive

As a connected solution, Microsoft tools can make collaboration much more seamless, with everyone in the business using the various apps to communicate and work together on various types of documents - keeping them together and accessible for auditing purposes in one portal.

At the same time, integrated messaging and video conferencing facilities can keep everyone on the same page throughout a long and complex process.

When it comes to compliance, the package also promises “no code” workflow creation through access to the latest visual building tools.

The MS website states you can: 

“Automate business processes with Microsoft PowerApps and Microsoft Flow built right into your SharePoint list or library.”

Challenges with using Microsoft 365 for your QMS

But the problems of building out more complex and sector-specific compliance workflows and tweaking them to your business needs remain. 

For example, it will require considerable time, money, and skilled resource to create a complete solution for medical device developers. As a warning to any would be DIYer, the Microsoft 365 GxP Guidelines run for over 100 pages!

What’s more, access to these solutions can cost in excess of £22 per month per user (payable annually) and you might end up having to pay more to access compliance features in the E5 package, anyway.    

What seems like a good solution to bring an entire business together using familiar and accessible software can end up being a massive (and expensive) IT project.

The problem with Microsoft

It’s understandable that companies will gravitate towards software that seems ‘low cost’ or ‘no cost’ when they’re starting out. But in complex, highly technical projects where new documentation and processes are being continually introduced and updated, it’s very easy for a homegrown digital QMS to become unwieldy and difficult to manage. 

A DIY solution can struggle to enable version control, or publish required assemblies of documentation (such as a medical device technical file).

What will it cost?

Many organisations gravitate toward Microsoft believing they can create an “advanced” DIY QMS without major investments. In practice, however, the term “DIY” is something of a misnomer. 

Rather than simply turning on a few tools you already own, achieving true compliance workflows and automated governance typically requires specialised knowledge and substantial consultant support for bespoke configurations of SharePoint and Microsoft 365. Calculating typical industry consultant rates, just the initial design and implementation of a QMS could run anywhere from £5,000 to £20,000, with ongoing maintenance and ad-hoc support fees adding uncapped financial burdens year on year.

What’s the alternative?

Modern, cloud-based QMS software developed with SMEs in mind can help you build out robust document management and workflow solutions robust quickly and easily. 

These solutions operate as secure ‘digital frameworks’ in which you can build up, iterate, and index key quality documents, all subject to the highest standard of version control.

Most importantly, they are designed to become the secure, yet accessible heart of your operations.  They can help make quality simply ‘the way you do things’ and your processes easily auditable by regulators. Crucially, they can deliver scalable and robust Quality Management in a highly cost-effective way.

It’s certainly worth exploring your options before you crack open the Microsoft toolbox.

Blog post updated on 25/03/2025