The DIN EN ISO 9001 has proven to be an effective process-oriented quality management system in healthcare and is continuously being developed further. The 3rd edition of the practical guide clearly and comprehensively describes the new developments and standard requirements. Through numerous examples, checklists, and self-assessment questions, the work provides assistance in establishing a quality management system that is individually tailored to each institution. The knowledgeable author has incorporated her extensive expertise as a quality manager into the work. Her broad knowledge in the medical field also makes the work practical and enhances the successful presentation.