A Quality Management System (QMS) is a structured framework designed to ensure that products meet regulatory and quality standards and are consistently safe and effective. It ensures that products brought to market by sponsors comply with relevant regulatory requirements throughout their lifecycle, even if the sponsor is not directly involved in manufacturing or supply.
While sponsors typically bear the primary responsibility for QMS compliance, suppliers and distributors may also be required to implement a QMS as outlined in their contracts or agreements with sponsors or other partners. These agreements often require all parties to uphold quality standards to maintain product safety and performance throughout the product’s lifecycle.
Additionally, sponsors and other stakeholders may be subject to audits by regulatory authorities or business partners to assess the effectiveness and compliance of their QMS. Even non-sponsors may be included in these audits if they are part of a regulated supply chain. A well-implemented QMS ensures readiness for such audits and helps minimise the risk of disruptions or non-compliance.
In audits we’ve supported across both sponsor and distributor organisations, several recurring issues have emerged. For sponsors, these often include gaps in oversight of third-party suppliers, unclear QMS responsibilities in quality agreements, and limited visibility over outsourced activities. For distributors, we’ve seen weaknesses in temperature monitoring during storage and transport, insufficient procedures for handling complaints and recalls, and a general lack of clarity around responsibilities relating to the sponsor’s QMS. These issues can pose significant compliance risks across the supply chain. Ensuring all parties maintain a fit-for-purpose QMS with clearly defined roles and robust procedures is critical to maintaining product quality, protecting patients, and ensuring audit readiness.
Whether you are a sponsor, supplier, or distributor, maintaining a robust QMS is essential for meeting your obligations and ensuring product quality and safety at every stage — from manufacturing to post-market. It also supports risk management, builds trust with business partners, and demonstrates a commitment to compliance and continuous improvement.
At Commercial Eyes, we specialise in helping sponsors, suppliers, and distributors navigate the complexities of regulatory and quality compliance, including the implementation of a Quality Management System (QMS). We provide expert guidance to ensure your business meets its obligations, whether you’re directly involved in product manufacture or play a role in distribution.
Our team offers expert guidance on regulatory expectations, helping you develop a QMS that aligns with the required standards. We don’t just review existing systems — we prepare and implement a QMS tailored to your specific needs. While we provide advice on industry best practices, we also make sure your QMS is practical, ensuring it’s not overly complicated or detailed unless necessary. This approach helps create a streamlined, efficient system that meets regulatory requirements without adding unnecessary complexity or burden.
By assessing your operations and understanding your business needs, we ensure that your QMS supports compliance, reduces risks, and supports product quality and safety. With our tailored support, we help you navigate your QMS obligations effectively, ensuring your systems are fit for purpose and ready for inspection.
Sponsors, suppliers, and distributors play key roles in ensuring products meet
regulatory standards and maintain quality. A well-structured Quality Management System helps
manage risks, ensure compliance, and support audits throughout the product lifecycle.
Maria Dionyssopoulos
Head of Regulatory, Quality and Compliance
Maria has extensive experience in developing regulatory strategies and providing insightful regulatory advice to a variety of...
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