An Iso 13485-certified Quality Mana

Taylor & Francis

Developing an ISO 13485-Certified Quality Management SystemAn Implementation Guide for the Medical-Device Industry\nAuthor(s): Ilkka Juuso\nFormat: Hardback\nPublisher: Taylor & Francis Ltd, United Kingdom\nImprint: Productivity Press\nISBN-13: 9781032065748, 978-1032065748\nSynopsis\nDeveloping an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry details the lessons learned from a real-world project focusing on building an ISO 13485:2016 Quality Management System (QMS) from scratch and then having it officially certified. It is a practical guide to building or improving your existing QMS with tried and tested solutions. \n\nThe book takes a hands-on approachfirst teaching the top 25 lessons to know before starting to develop a QMS and then walking you through the process of writing the quality manual and the standard operating procedures, training the staff on the QMS, organizing an internal audit, executing a management revie.