ISO 9001 and ISO 13485 

ISO Certifications

Rosti is ISO 9001:2015 and ISO 13485:2016 Certified

Quality management and quality assurance are more than just operational standards for Rosti – they are core functions of each element of our business. Our team members are committed to ensuring safe and reliable products and services in the design for manufacturability process through to production completion. Adherence to ISO standards provide significant value to our customers by increasing productivity, and reducing costs, waste and defects.  

Rosti maintains the following ISO certifications: 

ISO 9001:2015

The international standard that specifies requirements for a quality management system (QMS).Rosti maintains the standard to demonstrate the ability to consistently provide products and services that meet customer and regulatory requirements. 

ISO 13485:2016

Safety and quality are critical in the medical device industry. As regulatory requirements are increasingly stringent throughout every step of a product’s life cycle, organizations in the industry, and those that support the industry, should demonstrate their quality management processes and ensure best practices.

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.