For the attention of certification bodies

Management Systems Certification Bodies, that have accreditation or are in the process of getting accreditation against ISO/IEC 17021 in the scope of medical devices management systems certification against ISO/IEC 13485, shall note, that starting from 08 January 2016 a Mandtory document of the International Accreditation Forum, IAF MD 8:2015 Application of ISO/IEC 17011:2004 in the Field of Medical Device Quality Management Systems (ISO 13485)is to come into force. The document is available for download on official IAF web site via the following link:

http://www.iaf.nu/articles/Mandatory_Documents_/38

This document specifies normative criteria for Accreditation Bodies assessing and accrediting Conformity Assessment Bodies which provide audit and certification to ISO 13485, in addition to the requirements contained with ISO/IEC 17011:2004. It is also appropriate as a requirements document for the peer evaluation process for the IAF Multilateral Recognition Arrangement (MLA) among Accreditation Bodies.