Quality Management System
Quality Management System
Section 4 outlines the general requirements for establishing a QMS, emphasising the need for a documented system that defines processes, identifies resource needs, and manages the interactions required to achieve quality objectives.Additionally, organisations should address elements such as risk management, process approaches, and implement controls to ensure compliance with regulatory standards. This foundational section sets the framework for consistent quality across all areas of the medical device lifecycle, from design to distribution.Seal facilitates the various aspects of document management, such as process tracking, risk management, and version control to support the lifecycle of medical device products, from development to distribution. Seal enables the ability to execute controls such as (but not limited to):
- Reviewing and approving documents
- Displaying status of documents and enabling relevant versions of applicable documents to be available at points of use
- Legible and readily identifiable
- Detailed audit trail
- System is maintained to provide evidence of conformity to requirements and of the effective operation of the QMS
Management Responsibility
Management Responsibility
Section 5 emphasises the role of top management in establishing, implementing, and maintaining an effective QMS for medical devices. This section covers several critical aspects, such as:
- Quality policy, objectives, and planning
- Responsibility, authority, and communication
- Management review
Resource Management
Resource Management
Section 6 details requirements for ensuring that an organisation focuses on the provision of resources, such as personnel, infrastructure, and working environment. Organisations should also ensure necessary competencies of peronnel, provide training as needed, and evaluate the effectiveness of these activities.Seal supports the above by helping organisations effectively manage personnel, infrastructure, and work environments. Processes, workflows, and dashboards can be set up to track staff competencies and certifications, as well as for planning purposes. Seal’s Training Management also enables efficient tracking of training within the organisation, storing all training records of current and past users.Seal is not responsible for the setting up of such workflows, or providing resources beyond the means of the platform.
Product Realisation
Product Realisation
Section 7 details requirements for the processes involved in bringing a medical device from concept to market. This section outlines critical areas to ensure product quality, safety, and regulatory compliance, such as:
- Planning of product realisation
- Customer-related processes
- Design and development
- Purchasing controls
- Production and service provision
Measurement, Analysis and Improvement
Measurement, Analysis and Improvement
Section 8 defines processes for monitoring, measuring, analyzing, and improving the QMS to ensure continual compliance and product quality. This includes components such as:
- Feedback and complaint handling
- Internal audits
- Monitoring and measurement of processes and product
- Analysis of data
- Improvement