Author Archives: Michael Gamlen

What is a Quality Management System? People have different ideas of what a Quality Management System is, so to avoid any misunderstanding, here is our definition: A Quality Management System establishes policies and objectives to direct and control an organisation with regard to quality. A Quality Management System refers to an organisation which is compliant with a standard such as ISO 13485. To be successful, it requires ongoing commitment from senior management. 1. Gain commitment from senior management The first requirement is to ensure senior management recognise the need for a Quality Management System and are committed to supporting its Continue reading →