Star Rapid is certified and compliant with ISO 9001:2015, ISO 45001:2018 and ISO 14001: 2015. These ISO standards specify the management requirements for quality, occupational health and safety and environmental protection. They demonstrate our commitment to consistently providing you with high-quality prototyping, volume production and related services.
Our most recent certification is ISO 13485: 2016, which specifically regards the quality system for medical device manufacturing and other health-related services.
These management systems, along with our advanced inspection, measuring and testing equipment, ensure you will always receive products that meet and exceed your expectations.
Defines and controls a companyās quality management system for manufacturing medical devices, health-related products and supporting services.
Creates the framework for ensuring that all critical processes are fully documented, trained on and adhered to.
Focuses on occupational health and safety. We are always working to protect the health of our staff and visitors.
Controls our environmental management system. We take our responsibility seriously to be good stewards of the environment.
Star Rapid is dedicated to being a world-class provider of manufacturing solutions for medical product developers. Our ISO 13485:2016 certification offers you peace of mind that our raw materials, testing, inspection and production processes adhere to strict quality control guidelines necessary for regulatory approvals.
This helps you when youāre ready to submit your products for classification to the FDA in the United States or the European Medicines Agency (EMA).
We received our first ISO: 9001 certificate in 2013, and have been continuously improving our systems since then. Over the years, the manufacturing discipline of ISO standardization has helped us maintain leadership in our field.
ISO: 9001 was one of the first management systems that established standardization, documentation and consistency as key to controlling the quality of the finished product.
The ISO 45001: 2018 Occupational Health and Safety Standard helps us analyze risk factors in our business and then lays out a strategy to mitigate or eliminate those risks to prevent downtime and costly injuries.
Here are the benefits of this management system.
Protecting the environment is every bit as important as protecting the safety of the workforce. Under the guidelines of ISO 14001:2015, weāve established an environmental management system that follows the discipline of Plan-Do-Check-Act for continual improvement.
With the implementation of this system, we can:
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