Quality assurance

Amplivox design, manufacture, supply and support products on a global basis to satisfy customer requirements and meet many regulatory requirements. It is therefore essential that Amplivox have rigourous and proactive quality assurance schemes in place to ensure that we achieve our Quality management goals at all times.

ISO 9001:2008

An internationally recognised standard for the quality management of a business. it focuses on the procedures and processes that an organisation has set up to ensure quality assurance across all aspects of design, and manufacture of products in a systematic and controlled manner to achieve the needs and expectations of customers are met.

ISO 13485:2012

Specifies the requirements for a quality management system where an organisation needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.