Harmonization of accreditation to ISO15189

Over the years, ISO15189 has established itself as the international standard for quality management systems for all fields in laboratory medicine. As a result, also accreditation to this standard has increased in international adaptation. As a consequence, its impact grows as governments make the standard obligatory and/or national funding systems require ISO15189 accreditation for reimbursement. All these trends amplify each other. This overview aims to specify how ISO15189 has gained its current position as the harmonized quality standard that is not affected by borders between scientific (sub)fields nor between nations. From there, future challenges, opportunities and risks are addressed.