What is ISO 13485?
ISO 13485:2003 is a standard for quality management systems in the manufacturing and/or provision of medical devices and related services. ISO 13485 harmonizes medical device regulatory requirements for quality management systems and is specific to organizations providing medical devices – regardless of type or size.
ISO 13485 works in connection with then general ISO 9001 (link), though replaces its emphasis on continual improvement and customer satisfaction with meeting regulatory and customer requirements, enhanced risk management and maintaining effective processes. Other differences include better controls in product development and safety, inspection and traceability of implantable devices, documentation and validation of processes for sterile medical devices, and the effectiveness of corrective and preventive actions.
We help you succeed
It is important for us at Billet to support customers meet ISO 13485 requirements – and we do so by following ISO 13485 ourselves. Customers in North America and around the world can trust Billet to supply devices, components and parts that seamlessly integrate with their most stringent of ISO 13485 requirements. ISO 13485 is a new certification for Billet (2015) – new documentation has been created and added to Billet’s overall ISO9001 manual.
Our work in the medical services industry:
Billet is a manufacturer of “World Heart” implantable medical devices – we maintain strict adherence to quality inspection and traceability. We seek qualified partners to work with in the creation of further devices, components and parts relating to the medical devices industry.