A modular QMS framework
A tool-agnostic and modular QMS framework to decouple departmental agility from regulatory compliance. Intended to help startups and manufacturers establish a scalable and compliant quality management workflow from day one.
Key ideas
- You don't need Sharepoint or a top-down QMS. Let engineers use the best tools for their job to focus on agility - not compliance. Free them up for their core work.
- You don't need PDFs for internal documentation.
- Use a lightweight QMS app to create and track object IDs. Use these IDs in any other system.
- Don't spend money on tools and licenses. Use open-source tools for large annual savings with a marginal cost of growth.
The Challenge: Agility vs. Compliance
Traditional document control mandates a choice between a manual spreadsheet or a rigid, top-down Document Management System (DMS) like Sharepoint. This creates a friction point between engineering agility and regulatory compliance; while engineers require specialized tools like GitLab, Confluence, or CAD vaults to maintain speed, auditors require a frozen, traceable record. Legacy systems attempt to force both Identity (the metadata) and Content (the file) into a single container, resulting in a "PDF tax" where time is spent exporting and re-uploading snapshots to satisfy a fixed storage structure.
The Result: A Modular approach to quality management
A Modular QMS Framework addresses this by decoupling the unique quality object IDs from the storage medium, utilizing a central QMS app as a tool-agnostic "Source of Truth". This architecture allows the central registry to manage legal identity, status, and audit timestamps while departments remain in the systems most efficient for their specific work. The result is a "Ground-Up" infrastructure that ensures audit-readiness through automated ID uniqueness and immutable logging without monolithic overhead. By managing identifiers rather than files, the framework provides a scalable map of company intelligence that remains intact even if the underlying software stack changes.
Reclaimed Engineering hours
The most significant fiscal impact of a modular QMS is not the costs saved in licensing; it is the thousands of hours of engineering time bought back over three years. By eliminating the "PDF tax" and the friction of a central DMS, you effectively increase your R&D capacity without increasing headcount.
Annual Efficiency & Cost Analysis (50 Users - Realistic Scenario)
| Category | Legacy DMS (SharePoint) | Modular Internal QMS | Annual Savings |
|---|---|---|---|
| Software Licenses | $8,400 | $0 | $8,400 |
| Internal Maintenance | $0 | $1,000 | ($1,000) |
| Admin Time per Engineer | 52 hours / year | 8 hours / year | 44 hours / year |
| Total Team Friction | 2,600 hours | 400 hours | 2,200 hours |
| Productivity Value ($100/hr) | ($260,000) | ($40,000) | $220,000 |
| TOTAL ANNUAL IMPACT | ($268,400) | ($41,000) | $227,400 |
Note: This "Realistic" scenario accounts for 1 hour of weekly administrative friction per engineer, including context-switching costs.
Example framework
The below is a self-hosted and open-source approach to QMS related specifically to documentation. Ensuring digital sovereignty and scalability:
- A modular QMS app served via your companies infrastructure to create and track object IDs e.g., egamidocs/modular-qms-app.
- NextCloud for all internal documentation (via NextCloud Hub), and as an endpoint for customer access to PDFs.
- GitLab for external documentation for rigid traceability and requirements management (via a code-based documentation tool).
For a similar cloud-based approach:
- A modular QMS app served via your companies infrastructure to create and track object IDs e.g., egamidocs/modular-qms-app.
- Confluence for all internal documentation and as an endpoint for customer access to PDFs.
- Bitbucket for external documentation for rigid traceability and requirements management (via a code-based documentation tool).
It all connects via a simple API and that's it.. nothing else needed to maintain quality requirements.