[Certification of an ambulatory gastroenterologic service fulfilling ISO Law 9001--criteria and national guidelines of the Gastroenterologic Association].

The objectives of certification and accreditation are the deployment and examination of quality improvement measures in health care services. The quality management system of the ISO 9001 is created to install measures and tools leading to assured and improved quality in health care. Only some experiences with certification fulfilling ISO 9001 criteria exist in the German health care system. Evidence-based clinical guidelines can serve as references for the development of standards in quality measurement. Only little data exists on the implementation strategy of guidelines and evaluation, respectively. A pilot quality management system in consistence with ISO 9001 criteria was developed for ambulatory, gastroenterological services. National guidelines of the German Society of Gastroenterology and Metabolism and the recommendations of the German Association of Physicians for quality assurance of gastrointestinal endoscopy were included in the documentation and internal auditing. This pilot quality management system is suitable for the first steps in the introduction of quality management in ambulatory health care. This system shows validity for accreditation and certification of gastrointestinal health care units as well.