MBSE-Based Development of a
Digital QMS solution
Client: Multi-Unit Industrial Manufacturer
Core Pain Point: The client lacked a centralized, standardized process for handling after-sales technical support, covering customer feedback, returns, repairs, and engineering service requests, across four diverse business units. This fragmentation led to inconsistent documentation, inefficient feedback loops, duplicated effort, and poor visibility across teams. These inefficiencies hampered the group’s goal of ISO-9001 certification and delayed process improvements across business units.
Objective: To design and validate a modular, ISO-9001-compliant digital quality management system (QMS) that centralizes after-sales workflows, enables phased rollout across legacy environments, and delivers traceability, process efficiency, and measurable compliance across all units.
Approach: We applied a Model-Based Systems Engineering (MBSE) methodology using our "6-steps-process", integrating modular architecture design with stakeholder-driven requirement mapping, simulation-supported validation, and phased implementation targeting both local and corporate compliance goals.
Outcome: The MBSE-based Digital QMS delivered a 30% reduction in request resolution time, improved audit readiness, and enabled cross-unit visibility through centralized dashboards. High user adoption and modular scalability supported phased rollout, positioning the client for ISO-9001 certification and long-term process improvement across all business units.
6
Steps
Process
The 6-step process is a structured MBSE approach that moves from defining the problem to deploying a validated solution. It begins by aligning on objectives, then captures detailed requirements, designs the system architecture, and builds a simulation model. This model is tested to refine performance, and the final solution is validated and deployed. Each step ensures traceability, reduces risk, and delivers a scalable, ISO-compliant workflow.
1. Define the Problem & Deliverables
We partnered with the Group Technical Manager and key stakeholders from four business units to: Identify fragmented processes in technical support, engineering services, and feedback handling. Establish high-level deliverables aligned with ISO-9001 certification targets, including documented workflows, traceability, and measurable service outcomes. Define the phased deployment scope, starting with one pilot unit and expanding to others as maturity increased. 🔹 Deliverable: Problem Definition, Deployment Strategy, and System-Level Objectives
2. Develop Workflow Requirements
We conducted structured requirements gathering across business units to document: ISO-9001 compliance checkpoints (e.g., document control, audit readiness, risk-based thinking). Functional requirements such as request intake, customizable workflows, feedback loops, and audit trail mechanisms. System constraints, including varying legacy platforms and user roles. Performance expectations for customer experience and post-service support metrics. 🔹 Deliverable: Requirements Specification, Compliance Checklist Mapping, Role-Based Needs Matrix
3. Develop Workflow Architecture
We translated requirements into a modular architecture supporting phased integration by: Designing reusable core modules (e.g., Tech Request Management, ISO Compliance Tracker). Enabling per-unit workflow customization while preserving standardized corporate oversight. Mapping user roles to business logic (e.g., engineers, service teams, auditors). Defining a centralized platform logic layer to enforce ISO interpretation uniformly. 🔹 Deliverable: Modular System Architecture, Workflow Customization Plan, Role-to-Task Map
4. Build and Simulate Workflow Model
Using MBSE principles and SimEvents® modeling, we simulated technical support workflows to: Model task routing, document handoffs, and escalation patterns across roles and modules. Stress-test legacy system integrations and data migration assumptions. Quantify the effect of role-based UI customization and data access partitioning. 🔹 Deliverable: Parametric Workflow Model, Simulation of Pilot Unit (Weidmüller), Interface Specification
5. Test and Analyze the Workflow Model
We validated system functionality and user interactions through: Functional testing of each module against predefined ISO-9001 criteria. Pilot rollout at Weidmüller Printing Services, tracking live feedback resolution cycles. Integration testing with ERP and legacy tools. Evaluation of user training impact via structured feedback. 🔹 Deliverable: Module Test Reports, Gap Analysis, User Feedback Summary, ISO Audit Readiness Report
6. Validate and Deploy Optimized Workflow
Final validation and phased deployment included: Stakeholder review of pilot results and feedback-driven adjustments. Management review and approval for broader rollout. Finalized deployment template supporting multi-tenancy, secure access, and ISO-aligned audit trails. Documentation and training guides for future onboarding across units. 🔹 Deliverable: Deployment Package, Final System Architecture, Training Kit, and ISO Audit Logs
QMS solution
Our digital QMS platform, powered by MBSE and ISO-9001 compliance modules, unifies core quality functions—such as document control, audits, risk management, CAPA, training, and supplier feedback—into a traceable, standards-driven workflow.
MBSE principles enable simulation-based process design, while API integration connects seamlessly with third-party ERP and CRM systems, minimizing data silos and duplication across departments.
Automated workflows, real-time dashboards, and audit-ready records enhance compliance and decision-making. Role-based access, training tools, and modular portals support user accountability, collaboration, and phased adoption.
The result is a scalable, future-ready solution that reduces manual effort, improves response times, ensures ISO compliance, and drives continuous operational efficiency.