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HomeAAA NewsIAF requirements in the field of Medical Device Qual…
AAA News

IAF requirements in the field of Medical Device Quality Management Systems

Published
February 11, 2022
Source
AAA Newsroom
AAA Newsroom

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.

You can get the full document from here: https://iaf.nu/iaf_system/uploads/documents/IAF_MD9_Issue_4_01022022.pdf

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