Medical Devices Quality Management System (QMS – ISO 13485:2016)
- An integrated administrative framework designed to ensure the quality, safety, design, manufacturing, and supply of medical devices in full compliance with regulatory and customer requirements, based on the international standard ISO 13485:2016.
- This system enables organizations to convert quality practices, regulatory requirements, and accumulated operational expertise into a structured management framework that improves institutional performance, reduces risks, and ensures consistent control across all product life-cycle stages—from concept to post-market activities.
- System Components
1- Quality Management System Manual
Defines the principles, organizational structure (e.g., quality management, compliance officers, operational teams), roles, responsibilities, and application mechanisms across the device life cycle.
2- Quality Policies
A set of corporate commitments governing product design, development, procurement, manufacturing, post-market surveillance, and withdrawal/recall processes
3- Detailed Operational Procedures
Comprehensive procedures covering the entire operational cycle: product planning, design, purchasing, production, verification/validation, distribution, and post-delivery activities.
Also includes risk management, equipment calibration, traceability, labeling, and documentation controls.
4- Quality Records and Forms
Professional documentation covering: Design History File (DHF), Device Master Record (DMR), supplier evaluation records, verification/validation reports, calibration logs, distribution records, complaint handling, recalls, CAPA, training, and more.
5- Regulatory Integration Mechanisms
Medical devices are heavily regulated; therefore, the system integrates local and international regulatory requirements (e.g., FDA, EU MDR) and reflects documentation, traceability, and post-market reporting obligations.
Key Features and Advantages
- Establishes a systematic culture emphasizing quality, safety, and regulatory compliance
- Protects product quality across its life cycle—design, production, distribution, and post-market surveillance
- Converts individual know-how into organizational assets ready for reuse and audit
- Enhance operational efficiency by reducing rework, nonconformities, and variability
- Supports innovation through structured verification, validation, and continuous review
- Integrates naturally with other management systems such as risk management, safety, environmental management, and regulatory compliance
System Deliverables
- A complete and structured Quality Management System Manual for medical devices
- Clear, well-defined quality policies reflecting the organization’s regulatory and quality commitments
- Operational procedures covering all stages of the medical device life cycle
- Professional forms and records, including supplier logs, calibration logs, complaint records, distribution logs, validation reports, CAPA records, and more
- All documentation is editable (e.g., Word format) and can be integrated into digital QMS platforms
Institutional Impact
- Strengthens institutional capability by ensuring that medical devices are safe, effective, and compliant—building trust with users, customers, and regulators
- Improves operational efficiency by reducing defects, rework costs, and recall risks
- Boosts innovation by enabling structured product and process review
- Facilitates access to global markets where ISO 13485 certification is a key requirement
- Protects the organization from regulatory and legal risks arising from poor documentation or non-conformities
- Supports end-to-end control of post-market activities: complaints, corrective actions, updates, and recalls
