ISO 13485:2016: Quality Management System for Medical Laboratory Equipment Manufacturing Organization. This ISO standard is for Medical Laboratory Equipment Manufacturing Organization gives assurance of international Quality Management System.
Meaning of ISO 13485:2016 (in detail): Here ISO meaning: International Organization for Standardization, 13485 means: family introduction name of ISO series for Medical Equipment Quality Management System and 2016: Publishing Year of standards. (ISO 13485:2016).
Documents are required for ISO 13485:2016 Registration
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