New requirements from standardization and accreditation - the state of the art concept for quality and competence in medical laboratories

The new draft of the international standard ISO/DIS 15189:2011 "Medical laboratories - Specific requirements for quality and competence" sets substantially extended requirements for the quality management system of medical laboratories. The changes may be differentiated into three categories: editorial, structural and contents. Essential criteria of this standard, which is intended to be also applied for accreditation purposes, are related to novel management and technical requirements. In the center of the quality management documentation, the future standard not only requires a quality manual but also a set of more than 20 mandatory "documented procedures". For the subcontracting of referral laboratories, the draft standard contains a clear obligation for identification of the subcontractors which will increase overall transparency for patients and other laboratory users. Concepts for risk management and extended review activities are newly introduced into the draft standard. Key aspects of the technical requirements are related to the specification of criteria for validation and verification of examination procedures and to the quality assurance of examination results. The new draft standard requires - according to the current state of the art - compliance with selected quality criteria for report validation and the laboratory information management system. In a regulatory context, the ISO/DIS 15189:2011 is related to the current revision of the European medical device legislation, which - among others - covers in vitro diagnostic medical devices and which will be implemented by the national medical device act.