ISO13485 issued by the International Organization for Standardization (ISO) is the most widely used standard to manage quality in the medical device industry. It was written to support medical device manufacturers in designing a Quality Management System (QMS) which includes a Quality Policy, Quality Objectives and Quality Manual while establishing and maintaining certain processes. It ensures the consistent design, development, production, installation, and delivery of medical devices, making sure they are safe for their intended purpose. Its also just as important that the suppliers of key components of these devices also have an established QMS that aligns with those objectives.

ISO13485 provides a globally harmonized standard for quality management while serving as an important tool through the entire product life cycle. The most recent version of ISO13485 is from March 16 and it effectively covers ISO9001 with a few additional requirements.

For many decades SL Power has had these processes in place to demonstrate the commitment we have to the safety and quality of our products as well as ones that are manufactured by our customers. Officially obtaining ISO13485 certification from Underwriters Laboratories (UL) is a great milestone as it is the best internationally accepted standard a medical device or component manufacturer can have. With our QMS built in adherence to this standard, SL Power commits to implementing continuous improvement and building power supplies with the highest level of safety, quality and performance.