Developing Quality Management Systems
Developing Quality Management Systems
At TrueNorth, we specialise in helping businesses navigate the complexities of quality management.
Whether you’re a startup setting up your first Quality Management System (QMS) or an established company striving to maintain compliance, our expertise ensures your processes align seamlessly with regulatory requirements while enhancing operational efficiency.
Our tailored services help you establish or optimise a QMS that aligns with ISO 13485:2016 and other relevant standards. Our hands-on, collaborative approach focuses on creating systems that not only meet regulatory demands but also integrate smoothly into your daily operations.
Key elements of our approach include:
Gap Analysis: Assessing your existing processes and identifying areas for improvement or alignment with regulatory standards.
System Design and Implementation: Developing a compliant QMS framework customised for your business, with processes that span functions such as design and development, risk management, and post-market surveillance.
Cross-Department Integration: Advising on workflows that break down silos, fostering collaboration across R&D, operations, quality, and more.
Knowledge Transfer: Equipping your team with the skills and resources needed to independently manage and sustain your QMS.
A well-designed QMS is the foundation of success in the medical device industry. It ensures consistency, reliability, and compliance while building trust with regulators, partners, and customers. ISO 13485:2016 requires businesses to adopt processes that span multiple functions, promoting integration and efficiency across your organisation.
Many businesses encounter difficulties in developing or maintaining a QMS:
Overly complex systems that hinder productivity.
Disconnected processes that lead to inefficiencies and compliance risks.
Limited understanding of regulatory requirements.
With decades of experience in the medical device sector, we’ll guide you in overcoming these challenges, delivering a QMS that works for your business—not against it.
QMS Setup for Startups: Tailored solutions to help new businesses establish compliant systems from the ground up.
QMS Optimisation for Established Businesses: Streamlining existing systems to improve efficiency and ensure continued compliance.
ISO 13485 Certification Support: Guiding you through the certification process with comprehensive documentation and audits.
Electronic QMS Implementation: Developing modern, integrated systems using tools like Jira and Confluence for traceability and efficiency.
Experience: Over 20 years of expertise in quality management, regulatory compliance, and business processes.
Hands-On Approach: We work closely with your team, ensuring our solutions are practical and easily integrated.
Focus on Independence: Our goal is to empower you to manage your QMS effectively after implementation.
Tailored Solutions: Every business is different—we create systems that align perfectly with your goals and operations.
Ready to build or refine your Quality Management System?
Let us help you develop a QMS that drives efficiency, compliance, and success—complete with integrated design control processes for seamless product development.