Quality Management Systems
We have made significant investments in time, money and resources to build a robust Quality Management System (QMS) that aligns with the requirements of both ISO 9001 and ISO 13485 standards. This system supports every stage of our operations—from initial concept through design, manufacturing, and customer delivery—ensuring that our products consistently meet regulatory, performance, and safety expectations. Our QMS infrastructure includes clearly defined procedures, document control, traceability, supplier qualification, and internal audit mechanisms that promote continuous improvement and regulatory readiness.
Risk management is embedded into the foundation of our design and development processes. At every phase of a product’s lifecycle, from feasibility through verification, potential risks are assessed, documented, and addressed. Each design review integrates formal risk analysis to ensure that hazards are identified early, mitigated effectively, and monitored throughout development.
This proactive approach strengthens the reliability of our respiratory protection systems and reflects our commitment to delivering safe, high-quality, and certifiable products to frontline professionals.
Our Quality Policy
At Win-Shield Medical Devices Inc. (Win-Shield Devices), we have an unwavering commitment to design and deliver world-class, innovative protective and practical devices that meet the needs of law enforcement, military, industrial and medical personnel.
Our team collectively recognizes that the innovative products we create play an essential role in the safety, well-being, and capabilities of those on the front lines. We provide reliable and well-designed solutions that our customers can rely on to allow them to return home safely.
We are driven by a shared purpose — to protect those who protect us.
Core Principles
Innovation: We strive for continuous innovation and are pushing boundaries to create cutting edge and novel devices. Our focus on being an innovation leader enables us to provide solutions that meet the unique and evolving needs of front-line workers, healthcare professionals, and those in military and law enforcement.
Customer Engagement: We prioritize customer needs in our product design and development because we make it a priority to understand and anticipate the unique challenges faced by our customers. Our goal is to create innovative and integrated solutions that suit the ever-changing challenges of the work environment.
Quality Assurance: Our rigorous quality management and assurance processes ensure that every device that leaves our facility(s) meets the highest standards for reliability, durability, and performance. We adhere to industry regulations and standards, and we incorporate and follow best practices to guarantee the safety and effectiveness of our devices.
Our Commitment
Win-Shield Devices is committed to maintaining a Quality Management System that reflects our dedication to creating devices of the highest quality. We will monitor and improve our processes, ensuring our products contribute to the safety and protection of those who use them.
Our products empower those workers in the law enforcement, military, front-line, healthcare sectors, to confidently carry out their duties, knowing they can rely on our devices to protect them so they can come home safely to their families.
This policy is shared, understood and endorsed by all employees. Its effectiveness is regularly reviewed to uphold our commitment to innovation, quality, and customer satisfaction.