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The overall aim of our ISO 15189 documents is to support medical laboratories in ISO 15189:2012 documentation and give confidence to their customers (patients / corporate customers / hospitals, etc.), regulating authorities and accreditation bodies that are associated with the medical laboratory, as well as ISO 15189 consultants that all the documentation requirements are met by the laboratory.
ISO 15189:2012 accreditation documentation must include ISO 15189:2012 manual, ISO 15189:2012 procedures, records, SOPs, formats for technical areas specific to laboratory activities, audit checklist, etc.
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