ISO 13485 - Obstacle or Opportunity: How to live a QM system to benefit companies and employees

Setting up and living a quality management system for medical devices that is conform enough with the requirements of ISO 13485 to get certified is not witchcraft. The challenge is to involve all employees and to design a valuable construct of interacting processes, which in the end create a structure that is useful and helpful for the employees as well as for the whole company. This book provides the foundation for such a quality management system: - You learn in 1 - 2 sentences per standard chapter what its core contents are. - You will understand each individual requirement through a detailed analysis. - You will find practical implementation possibilities for each requirement. - You will understand the usefulness of each chapter (if it has one) with the help of a short summary. - You will get ideas on metrics to measure the effectiveness of the processes, where appropriate. - You get access to the forum at www.kal-leh.com to discuss ISO 13485 content and implementation possibilities with peers and the author. Andreas Kalchschmid-Lehmann, who has had deep insights into dozens of well and poorly functioning QM systems during his career as a technical assistant, quality manager, lead auditor at the Notified Body TÜV SÜD and consultant at the Johner Institute, delivers all of this in a calm manner and with a wink - which makes the admittedly dry topic appear pleasantly refreshing.