ISO 9001 is an international standard for quality management, drawn up by the International Organisation for Standardisation. It helps organisations to structure their processes in a way that ensures consistently good quality, meets customer expectations, and drives continuous improvement. With an ISO 9001 certification, an organisation demonstrates that quality and reliability are central to its way of working.
ISO 13485 is a set of international standards for quality management in the medical device sector, developed by the International Organisation for Standardisation. The standard helps organisations developing, manufacturing, or distributing medical devices to comply with strict quality requirements and legislation. With ISO 13485 certification, an organisation demonstrates that safety, reliability, and regulatory compliance are central to its processes.
