Top Free & Open-Source Quality Management Systems for Manufacturing In 2025
Quality Management Systems (QMS) ensure that products meet standards, processes stay consistent, and compliance is traceable. For manufacturers, open-source QMS tools can replace spreadsheets and manual audits, offering structured control over inspections, nonconformities, and corrective actions. In 2025, several mature open or open-core platforms provide QMS functionality suitable for industrial use.
1. QDMS (Quality Document Management System)
Best for: document control and ISO 9001 workflows.
QDMS is an open-source QMS focused on document management, audits, and compliance tracking. It supports versioning, controlled access, and approval cycles for quality procedures. Built for manufacturing and pharma use cases.
2. Bika / Senaite LIMS
Best for: laboratory and quality control integration.
Senaite (formerly Bika LIMS) is an open-source laboratory information management system that extends into quality management and traceability. It’s Python-based, supports QC sampling, batch tracking, and audit trails — widely used in food, materials, and pharma labs.
3. ISOxPress QMS (Community Edition)
Best for: small manufacturers seeking ISO 9001 compliance.
An open community QMS with modules for CAPA, audits, calibration, and training management. Offers PDF export, role-based access, and email notifications. Suitable for ISO 9001:2015 documentation and small-plant operations.
4. ProcessMaker Open Source
Best for: workflow-driven quality and CAPA automation.
ProcessMaker is a BPM/Workflow platform often used to build CAPA and audit workflows. Open-source core supports drag-and-drop process design and integration with ERP or MES. Ideal for automating approvals, deviations, and risk assessments.
5. qmsWrapper (Community Edition)
Best for: integrated quality + compliance + documentation control.
qmsWrapper is designed for medical device and manufacturing environments. Its community edition includes document control, risk assessment, and CAPA management with traceability logs. Commercial upgrades offer FDA and ISO templates.
6. SimpleQMS (Open License Edition)
Best for: teams implementing paperless document control.
SimpleQMS provides workflow-based document approval, versioning, and audit readiness. It’s open-core with community edition downloads for small teams, supporting compliance to ISO 9001 and 13485.
7. OpenQuality (GitHub Project)
Best for: manufacturing startups and research labs.
OpenQuality is a community-driven GitHub project offering issue tracking, nonconformity logging, and audit preparation. Lightweight and flexible, built on Node.js + MongoDB. Still early-stage but promising for teams wanting full transparency.
8. Mango QHSE
Best for: integrated safety and environmental management.
Mango offers a free community tier for small teams to manage quality, health, safety, and environmental data. Cloud-ready, audit-friendly, and simple to deploy. Paid editions add advanced analytics.
9. EtQ Reliance (Free Tier / Open-core)
Best for: enterprise-grade quality workflow automation.
EtQ offers a limited open-core and free community edition of its Reliance QMS. It includes document management, CAPA, audits, and supplier quality control. Suitable for large manufacturers needing structured workflow governance.
10. Qualitiso Tools (GitHub)
Best for: lean QMS implementation for startups.
Qualitiso offers open Excel, Python, and Markdown-based toolkits for risk management, FMEA, and design control. Lightweight, easy to integrate into existing MES or ERP systems for quality traceability.
Comparison Table
Platform | Type | License | Focus Area | Community Activity | Ideal Use |
---|---|---|---|---|---|
QDMS | Full QMS | GPL | Document & audit control | Medium | ISO & compliance |
Senaite / Bika | LIMS + QMS | GPL | Lab & process QC | High | Lab integration |
ISOxPress | QMS | Community | CAPA, audits | Medium | ISO 9001 plants |
ProcessMaker | BPM engine | AGPLv3 | CAPA workflows | Very High | Automation |
qmsWrapper | Hybrid | Open-core | Medical / manufacturing QMS | Medium | FDA / ISO env. |
SimpleQMS | Open-core | Proprietary free | Docs, approval | Medium | SME quality teams |
OpenQuality | GitHub app | MIT | Nonconformity, issues | Low | Startups |
Mango QHSE | SaaS / open-tier | Free | QHSE integration | Medium | Safety + quality |
EtQ Reliance | Open-core | Commercial / free tier | Workflow QMS | Medium | Large orgs |
Qualitiso | Toolkit | MIT | Risk & FMEA | Low | Lean QMS setup |
Recommendations
For manufacturers pursuing a structured, compliance-ready QMS, QDMS and ISOxPress are the most practical starting points. They balance traceability, document control, and CAPA tracking without heavy configuration.
For automation-first teams, ProcessMaker stands out — it lets you design workflows for audits, deviations, and approvals directly integrated with MES or ERP data.
Senaite/Bika is ideal when quality management ties to laboratory or material testing, while qmsWrapper and SimpleQMS are strong hybrid options for medical or regulated manufacturing.
Lean or early-stage teams can benefit from Qualitiso and OpenQuality, which focus on minimalistic, transparent approaches without enterprise overhead.
In 2025, open-source QMS systems give manufacturers the flexibility to build quality frameworks that reflect their processes — not just check compliance boxes. Whether you need ISO documentation, CAPA workflows, or lab-integrated QC, these tools form a strong foundation. When combined with MDCplus and MES data, they close the feedback loop between production performance and quality assurance, enabling continuous improvement across the factory floor.
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