The International Accreditation Forum (IAF) has published issue 4 of IAF MD 9: Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485).

ISO/IEC 17021-1 is an International Standard that sets out the general requirements for bodies operating audit and certification of organizations’ management systems. If such bodies are to be accredited as complying with ISO/IEC 17021-1 with the objective of auditing and certifying Medical Device Quality Management Systems in accordance with ISO 13485, some additional requirements and guidance to ISO/IEC 17021-1 are necessary.

The document specifies normative criteria for CABs auditing and certifying organizations’ Quality Management Systems to ISO 13485, in addition to the requirements contained in ISO/IEC 17021-1. It is also appropriate as a requirements document for the peer evaluation process for the IAF Multilateral Recognition Arrangement (MLA) among Accreditation Bodies.

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