A digital QMS that fits your sector, your standards and your way of working. Document control, audits, supplier assessment, complaints and CAPA in one environment, with integrations to your ERP, MES and LMS that off-the-shelf packages rarely handle well.
A good quality management system brings procedures, audits, non-conformities, training and suppliers together in one workflow. Not as loose SharePoint folders or a collection of Excel files, but as one coherent system in which a change to a procedure automatically triggers a training action, a complaint opens a CAPA, an audit finding reaches the right process owner, and a supplier NCR feeds into the next supplier assessment.
In practice we see four types of organisation. The first still works with network drives, Excel trackers and email; the QMS exists physically but lives outside any single system. The second has a light package, often Q-Pulse, Intelex or a local module, but lacks the depth for audits, CAPA or supplier assessment. The third has an enterprise package such as MasterControl, AssurX, ETQ Reliance, Sparta Systems TrackWise, Pilgrim Quality, Greenlight Guru or Veeva QualityOne, and pays for functionality it doesn't use while missing the sector-specific flows it needs. The fourth runs a different system at each site and wants to consolidate.
We build custom quality management systems for organisations in any of these situations where a new off-the-shelf package clearly won't fit. We work in Dutch, with your quality manager, against your standards, whether that is ISO 9001, ISO 13485, ISO 27001, ISO 20000, IATF 16949, AS9100, NEN-EN 9100, NEN-EN 1090, NEN 7510, BRC, IFS, HACCP, GMP or FSSC 22000.
If you work under a certification scheme, it comes with its own file. For food products that is the audit file for IFS and BRCGS; for medical devices, the MDR technical file.
Two schemes that often run alongside a quality system: KOMO with an assessment guideline for construction products, and the RI&E with action plan for the occupational health and safety side.
Depending on where you are now: replacing loose Excel workflows, extending an existing package, or a fully integrated platform for multiple sites.
Procedures, work instructions, forms and training materials managed centrally, with version history, an approval workflow and an integration with your training administration. Suitable as a starting point for organisations still working with network drives or a shared Excel index.
Document control plus internal and external audits, non-conformities (NCRs), CAPA, complaints logging, supplier assessment and calibration management. One dashboard with KPIs by process, site and standard. For organisations maintaining ISO 9001, ISO 13485 or a sector standard such as AS9100 or IATF 16949.
Mission-critical quality platform for multi-site groups, integrated with MES for real-time QC data, with ERP for purchasing and suppliers, and with an LMS for training. Includes an FDA 21 CFR Part 11 audit trail, electronic signatures, and role-based access for regulated businesses.
If you fall under the Dutch Cybersecurity Act (Cbw), it requires something a quality system does not provide by default: the link between identified risks and the measures you chose. See Cbw software.
If you issue an assurance report to your clients, a Type II report requires evidence across the entire period rather than a snapshot. See ISAE software.
Two registers sit close together here and are deliberately kept separate. The evidence for each implemented control is in the ISAE app; the reporting channel under the Whistleblower Act is in the whistleblower reporting app.
Every sector has its own standards, its own regulators and its own risks. Our quality management software is built around the standard you maintain, not the other way round.
ISO 9001, IATF 16949 for automotive, AS9100 and NEN-EN 9100 for aerospace, NEN-EN 1090 for steel construction. With direct MES integration for real-time QC data, statistical process control and first-pass yield monitoring. See our page on software for manufacturing.
Document control and audit trail in line with FDA 21 CFR Part 11, electronic signatures, validated change control, allergen management and batch traceability. For producers who face regular audits and have no room for manual workarounds.
For healthcare providers, clinical laboratories and manufacturers of medical devices. If you work under an HKZ scheme rather than ISO 9001, see HKZ quality manual and audit file. Includes integration with ICT incident management, training tracking for protocols, and validation documentation (IQ/OQ/PQ) for regulated processes.
Project-oriented QMS for engineering and installation companies. Work package-based inspections, supplier qualification, and integration with project management systems for scope and risk changes.
Information security management and service management in one environment. Asset register, control mapping to Annex A, evidence collection and automated reporting for the auditor, which suits organisations certified every year.
For holding companies where one operating company maintains ISO 9001 and another IATF 16949 or ISO 13485. One platform, site-specific configuration and consolidated group-level reporting.
A working QMS your quality team can manage itself, plus the documentation and training to pass audits with it. No vendor lock-in on a proprietary platform, and no annual licence escalation that your purchasing department has been complaining about for years.
We don't replace enterprise packages such as MasterControl or Veeva QualityOne where they already work well. We do build custom solutions when a standard package demonstrably doesn't fit your sector, your standards or your scale, for example because a specific audit flow or supplier assessment mechanism can't be configured, or because the package lacks a suitable API surface for deeper integration with your production or purchasing systems.
Four situations in which we help organisations build a custom QMS. If you recognise one, we'd be happy to talk further.
Your industry standard, such as AS9100 for aerospace, IATF 16949 for automotive, NEN-EN 1090 for steel construction or BRC/IFS for food, has requirements that a standard QMS package can only cover through workarounds.
You want QC measurements from the MES flowing straight into the QMS, supplier data from the ERP automatically linked to qualification status, or order information linked to complaints. A standard package rarely delivers that out of the box.
Your group uses a different QMS at each site, sometimes paper, sometimes Excel, sometimes a lightweight package. You want to consolidate into one environment without the most sophisticated site falling back to the lowest common level.
You want a structured supplier assessment in line with ISO 9001, with KPIs, performance tracking and qualification status, for hundreds of suppliers rather than a spreadsheet updated once a year.
With OneDayBuild, we turn your idea into something tangible in one day for €1,150, so you can see whether further development is worth the investment. Decide to go ahead with the full build? Then we credit the full cost.
Explore OneDayBuild →A conversation in which we establish which standards you maintain, which modules are a priority, which integrations are involved and which packages you currently use. We're honest when a standard package is a better fit than custom development.
Sessions with your quality manager, process owners and a representative from the shop floor. Existing workflows are mapped, pain points identified and the first screen flows sketched. At the end, a concrete scope per module and a sprint plan.
A working version every two weeks that you and your QA team can test. We usually start with document control and audit management, as these deliver value fastest, and expand modularly from there. A project spanning several sprints, not a big bang.
For regulated sectors: running IQ/OQ/PQ protocols, delivering validation documentation and setting up the transition to production together with your QA team. For non-regulated sectors: a phased rollout per site or per module.
After go-live we monitor the platform, deliver updates and build out the modules that fell outside phase 1. Changes to standards, such as a new revision of ISO 9001, are handled within ongoing maintenance.
A digital quality management system rarely consists of a single module. We build them modularly so you can start with whatever is causing the most pain and expand once the foundation is in place.
Procedures, work instructions, forms, standards documents and training materials managed centrally. Version history, an approval workflow, links to standard clauses, and automatic training actions on change. The core of any QMS, and the first module we almost always deliver.
Internal audits, external audits, supplier audits and self-assessments in one schedule. Annual audit programme, checklist templates per standard, findings with owner and deadline, and automatic links to the NCR and CAPA flow.
Register non-conformances from any source (audit, complaint, production, supplier), record root-cause analysis, and track corrective and preventive actions through to effectiveness review. Built for regulated sectors with an audit trail under 21 CFR Part 11.
Customer complaints from report through to resolution, with automatic escalation, root cause linkage and, where relevant, an MDR/vigilance reporting route for medical devices or a recall flow for food and pharma.
Approved supplier list, certificate management with expiry dates, periodic KPI-based assessment, and automatic alerts on performance deviations. The process that rarely stays accurate in a spreadsheet for long, and that ISO 9001 explicitly requires.
Measuring instrument register, calibration schedule, certificates, drift tracking and automatic blocks when calibration lapses. Can be linked to a CMMS maintenance management system so instruments without valid calibration are not used for inspections.
Which employee has completed which procedure training, which is due for refresher training, and who has read the latest document version. Can be linked to your LMS or used standalone.
FMEA at process and product level, a risk register, ICH Q9 for pharma, and integration with the change control module so that changes are assessed for risk. Read more on our page about custom risk management software.
Process, document and product changes with impact analysis, approval workflows and linked validation activities. For regulated industries, with electronic signatures and a full audit trail.
First-pass yield, cost of poor quality, defect rates per line, NCR trends, complaint throughput, audit finding status and supplier scorecards. Standard reports for ISO 9001, ISO 13485 or ISO 27001 audits.
Anomaly detection on QC measurements, automatic classification of incoming complaints, and pattern recognition across NCRs. Optional, and only where data volumes and quality justify it: no AI for the sake of AI.
Data immutability, electronic signatures, FDA 21 CFR Part 11 for regulated sectors, and standard export in the format your auditor or regulator expects.
What quality managers and QA directors usually want to know before we start.
A no-obligation half-hour introductory call. We listen to your standards, your current systems landscape and your bottlenecks, and give direction you can use, whether that means a custom build or a standard package that fits better.
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