Intersection Between Requirements of OECD-GLP, GCLP, and ISO/IEC 17025, ISO 15189 Standards

Accreditation of conformity assessment bodies is carried out according to applicable standards of the International Organization for Standardization (ISO). Any laboratory accredited to the ISO/IEC 17025 and/or ISO 15189 accreditation standards has a clear advantage, when preparing its facilities for implementing the principles of good laboratory practice (GLP) of the Organization for Economic Co-operation and Development (OECD) and/or good clinical laboratory practice (GCLP) guidance drafted by the European Medicines Agency (EMA). Both accredited laboratories and recognized test facilities operate an established management system specified in these standards, principles, and guidance. This management system, combined with the professional or technical aspects of the activities, provides a guarantee that the laboratory obtains the competence to conduct all its operations. The ISO/IEC 17025 and ISO 15189 accreditation standards and the OECD principles of GLP as well as the GCLP guidance recognition documents are compared and discussed in this paper. Discussion and conclusion regarding the intersection between quality and professional management requirements are presented and may contribute to future development.