Solutions / ISO 9001
Ingenes Studio QMS
compliant with ISO 9001:2015
Ingenes Studio QMS provides digital tools covering the key requirements of ISO 9001:2015 — from document management to data analysis and corrective actions. Certification is yours, the tool is ours.
ISO 9001 in numbers
Key areas of the standard digitally supported by Ingenes Studio QMS
Support areas
How Ingenes Studio QMS supports quality management
Instead of publishing a clause-by-clause map, we show the quality areas where the system structures daily work.
Context and responsibilities
Registers and system documents help describe scope, interested parties, roles, responsibilities and process owners.
Risks, objectives and planning
The risk and opportunities register supports risk assessment, action planning, quality objectives and KPI monitoring.
Documents and records
Document workflows cover versioning, approval, publication, archiving and controlled access to current information.
Competence and training
The Training module supports competence matrices, training plans, procedure acknowledgements and qualification history.
Operations, suppliers and traceability
The system supports product control, supplier evaluation, complaints and batch traceability with linked quality records.
Audits and reviews
Audit planning, finding registration, reports and KPIs help prepare management review inputs.
Nonconformances and CAPA
The CAPA module handles the cycle from problem registration through root cause analysis to corrective action and effectiveness verification.
Process improvement
Data from audits, complaints, inspections and corrective actions creates a basis for improving the quality system.
Why Ingenes Studio QMS
A tool designed with ISO 9001 in mind
Ready-made documentation structure
The system provides predefined document types (policies, procedures, instructions, records) aligned with the standard — no need to build from scratch.
Version control and approval
Every document goes through a configurable approval workflow. The system archives previous versions and prevents use of obsolete issues.
Traceability from raw material to shipment
Full batch traceability lets you answer an auditor's question about any product's history in seconds.
All auditor evidence in one place
All records required by the standard — inspection reports, audit reports, corrective actions — are accessible in one system, ready for PDF export.
Key module
Nonconformances and CAPA — the heart of an ISO 9001-compliant system
Internal nonconformance registration
Employees report nonconformances directly in the system. Every report is assigned to the responsible person and tracked to closure.
Root cause analysis
Built-in 5Why and Ishikawa diagram tools help get to the real cause of a problem, not just the symptom.
Action planning and verification
Each corrective action has an assigned owner, deadline and effectiveness criterion. The system reminds on approaching deadlines.
Effectiveness reporting
Nonconformance recurrence indicators, CAR closure time and trends over time — ready reports for management review.
Frequently asked questions
Questions we hear most often from companies preparing for ISO 9001 certification.
Is Ingenes Studio QMS ready for an ISO 9001 audit?
The system contains all features required to document conformance with the standard — documentation structure, nonconformance registers, audit reports and corrective action history. The certification decision belongs to the certification body.
Does the system support management review?
Yes. The reporting module lets you prepare review inputs: audit results, corrective action status, process measurement results, customer feedback and supplier evaluation.
How does the system handle document and record control?
Every document has an assigned owner, status (draft / approved / withdrawn), version and review date. The system blocks access to obsolete issues and automatically notifies of upcoming review dates.
Can I configure custom processes and control criteria?
Yes, Ingenes Studio QMS is fully configurable. Control plans, quality attributes, deviation thresholds and escalation paths are defined for your processes — without programming.
Does the system support supplier management?
The Suppliers module enables qualified and unqualified supplier evaluation, logging supplier complaints, tracking corrective actions and generating annual evaluation reports.
How long does it take to go live?
Ingenes Studio QMS is a ready-to-use tool. Configuration time depends on the complexity of the client's processes. Our team supports technical configuration — QMS implementation is led by the client or their consultant.
See Ingenes Studio QMS in action
Book a free demo and discover how the system handles ISO 9001 requirements in your processes.