Developing an ISO 13485-Certified Quality Management System

This book 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.

Aceasta carte detaliaza lectiile invatate dintr-un proiect real axat pe construirea unui Sistem de Management al Calitatii (SMQ) ISO 13485:2016 de la zero si apoi pe certificarea oficiala a acestuia. Este un ghid practic pentru construirea sau imbunatatirea SMQ-ului existent cu solutii testate si verificate.