Developing an ISO 13485-Certified Quality Management System: An Implementation Guide for the Medical-Device Industry Juuso Ilkka

Developing 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 helps you to progress from one task to the next and provides all the essential It is a practical guide to building or improving your existing QMS with tried and tested solutions.The book takes a hands-on approach-first 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 review, and finally passing the necessary external audits and obtaining certification.