ISO 151892007-Implementation in a Laboratory Information System

Abstract

ISO 15189:2007 constitutes an international certification standard, based upon ISO/IEC 17025 and ISO 9001, which can be used by medical laboratories wishing to improve their quality standards. The requirements of this standard form a group of general guidelines that will help laboratories establish and enhance their quality systems. Although direct references to the use of computer systems are made in only 7 cases, through the mandatory section of the ISO 15189:2007, many more clauses of the standard include indirect references to electronic medical records handling. The chapter analyzes the guidelines concerning the use of laboratory information systems for medical records storage and retrieval. Furthermore, the authors discuss challenging difficulties that may be detected during implementation of ISO 15189:2007 in the field of electronic laboratory medical records.