Should according ISO 15189 accredited medical laboratories be monitored by the federal state authorities?¹

Abstract The new guideline for quality assurance in medical laboratories (RiLi-BÄK 2008; Richtlinie der Bundesärztekammer zur Qualitätssicherung laboratoriumsmedizinischer Untersuchungen) describe in part A basic standards for quality assurance and quality management, which have to be implemented by all medical laboratories in Germany. Specific requirements are listed in part B. However, legal regulations can only be effective if compliance with these regulations is controlled. Dipl.-Biol Katharina Lehnigk offers the opinion that the obligation of state authorities to survey medical laboratories also applies to laboratories which are voluntarily accredited according to the European Standard ISO 15189. The state has to take care that the compliance with regulations is guaranteed. A transfer of survey obligations from state authorities to other institutions including accreditation bodies may be conceivable. Dr. Andreas Steinhorst from the accreditation body DACH (Deutsche Akkreditierungsstelle Chemie) reasons that state authorities should have confidence in the accreditation rules of ISO 15189 and therefore a surveillance of laboratories which have an accreditation according to ISO 15189 is not necessary. This holds particularly true since the standards of ISO 15189 have been partly adopted by the RiLi-BÄK 2008. However, the European Standard ISO 15189 is much more comprehensive than part A of the RiLi-BÄK 2008.