ISO 9001 – Quality Management System
ISO 9001 is a Quality Management Standard. It suits all organizations large or small and covers all sectors, including charities and the voluntary sector. It is suitable for organizations in all industry sectors and will help your organization to improve management processes to compete locally and/or globally. It aims to help organizations become structured and efficient.
ISO 13485 Medical devices Quality management systems — Require for regulatory purposes 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 requirements and regulatory requirements applicable to medical devices and related services.