Beyond Quality Management
Beyond Quality Management
At TrueNorth Services Ltd, we understand that effective business management is essential for the success of any medical device company. That’s why we go beyond traditional Quality Management Systems (QMS) to deliver integrated Business Management Systems (BMS) that unify processes across all departments. Whether you’re starting a medical device business or looking to enhance your existing quality systems, we’ll help you create a solution that drives efficiency and compliance.
The ISO 13485:2016 standard recognises the importance of cross-functional collaboration. By breaking down departmental silos, our approach empowers you to align your entire organisation under a single, cohesive framework.
Many off-the-shelf QMS platforms fall short in meeting the unique challenges of the medical device industry:
Document-Centric Focus: Most systems are limited to managing document control and traditional quality records, neglecting other crucial business areas like R&D, operations, or customer support.
Fragmented Systems: Disconnected tools often lead to inefficiencies, miscommunication, and gaps in traceability.
Lack of Adaptability: Prebuilt solutions often fail to account for the unique processes and workflows of individual businesses, resulting in a rigid, less effective system.
Collaboration Gaps: Limited collaboration tools make real-time communication and knowledge sharing across teams a challenge.
These constraints can prevent businesses from achieving their full potential. That’s where our expertise—and the Atlassian ecosystem—come into play.
We leverage the power of Atlassian tools like Jira, Confluence, Service Desk, and Bitbucket, transforming traditional eQMS into a robust, scalable Business Management System tailored to your unique needs.
Atlassian serves over 300,000 companies across 200+ countries, including 80% of Fortune 500 companies. Its tools are designed to scale with businesses, from startups to large enterprises.
Jira
We configure Jira with custom issue types for every record type you’ll need, e.g. requirements, risks, SOUP, security threats, technical designs, tasks, non-conformances, CAPAs, change notes, audits, objectives, test plans, test executions, and more.
Integrated workflows align with your processes, and links to enable traceability throughout your product lifecycle, allowing seamless project planning, tracking, and status updates, as well as conformity assessment — all in one place.
Confluence
With tailored templates for Design History Files, integrated document workflows, and electronic signatures, Confluence simplifies compliance documentation. Seamless integration with Jira allows dynamic content updates by pulling Jira issue data directly into your documents. This approach not only saves time and effort but ensures your documentation is always connected and up-to-date.
Service Desk
Empower your customer service and internal teams with streamlined workflows. Integrated with Jira, Service Desk ties customer feedback, incidents, requests, and postmarket surveillance back to your quality and business processes for a unified approach.
Beyond quality management
The Atlassian ecosystem enables us to extend far beyond traditional quality and regulatory functions. Jira and Confluence also come with project templates for HR, IT, Finance and more, supporting workflows for onboarding, expense approvals, and IT issue resolution. These out-of-the-box solutions seamlessly integrate into your broader management system, creating a unified operational platform.
Seamless Integration Across Departments: By dissolving departmental boundaries, we create a unified system that encourages collaboration and efficiency.
Tailored to Your Needs: Our deep understanding of the medical device sector ensures that every implementation is customised to align with your business goals and compliance requirements.
Enhanced Traceability and Compliance: Full traceability across records, workflows, and business functions ensures compliance with ISO 13485:2016 and other standards.
Real-Time Visibility and Decision-Making: Dashboards and reporting tools provide real-time insights, helping you stay proactive and informed.
At TrueNorth Services Ltd, we bring decades of expertise in both medical device quality management and Atlassian configuration.
Whether you’re starting a new venture or improving an existing system, we’ll help you design and implement a business management solution that’s as innovative as your products.
Ready to elevate your business processes? Contact us today to learn more about how we can help.