IAF has published Issue 5 of the document IAF MD 8, 'Application of ISO/IEC 17011:2017 in the Field of Medical Device Quality Management Systems (ISO 13485).
The objective of the document is to enable Accreditation Bodies to harmonize their application of ISO/IEC 17011:2017 for the accreditation of bodies providing audit and certification to ISO 13485.
The document further specifies normative criteria for ABs assessing and accrediting CABs which provide audit and certification to ISO 13485, in addition to the requirements contained with ISO/IEC 17011:2017.
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