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Everything you want to know about ISO 15189:2012 Medical Laboratories – Requirements for Quality and Competence. ISO 15189:2012 Editable Document kit for medical laboratories. Sr. No. List of Directory. Document of Details. 1. Quality Manual. 01 files in MS Word.ISO 15189 was prepared by Technical Committee ISO/TC 212, Clinical laboratory testing and in vitro diagnostic test systems. This second edition cancels and This International Standard, based upon ISO/IEC 17025 and ISO 9001, specifies requirements for competence and quality that are particular to medical This working document is intended as a checklist for the assessor when conducting Medical Testing. Laboratory Accreditation Assessments according to ISO 15189: