Quality Management Systems (QMS) help organizations systematically plan, control, and continuously improve the quality of products, processes, and services. They align internal quality objectives with external requirements such as international standards and norms (e.g. ISO 9001, ISO 13485, IATF 16949) as well as industry-specific regulations.
A QMS provides transparency across all quality-relevant activities, reduces risk, and supports consistent compliance with legal and regulatory requirements. It typically covers all phases of the product or service lifecycle – from development and design through sourcing and production to delivery, complaints handling, and customer satisfaction. Quality managers, operations leaders, and compliance officers use QMS solutions to document deviations (e.g. OOS), recalls, and non-conformances, to perform root cause analyses, and to initiate targeted corrective and preventive actions (CAPA).
Modern QMS solutions integrate seamlessly with existing ERP, MES, and PLM systems (including discrete, ETO, and mixed-mode ERP), support real-time reporting, electronic signatures, and audit trails, and are often combined with EHS solutions to protect employees and the environment. In addition, they support engineering changes, end-to-end traceability across the product lifecycle, supplier evaluation, and quality assurance of equipment and assets.
To be listed in the Quality Management Systems (QMS) category, a solution should typically offer the following capabilities:
- Monitoring of deviations/OOS, non-conformances, and quality controls
- CAPA management and engineering change management
- Documentation and knowledge base for risk, compliance, and incident management
- Configurable workflows, checklists, inspections, and audits (including audit trails)
- Supplier and asset/equipment quality management (including asset compliance and traceability)
- Integration options with ERP, MES, and PLM as well as support for electronic signatures and (near) real-time reporting
