Transcription of IAF Mandatory Document
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IAF Mandatory Document
IAF MD 8:2020 International Accreditation Forum, Inc. IAF Mandatory Document Application of ISO/IEC 17011:2017 in the Field of Medical Device Quality Management Systems (ISO 13485). Issue 4. (IAF MD 8:2020). Issued: 29 June 2020 Application Date: 30 November 2020 IAF MD 8:2020 Issue 4. International Accreditation Forum, Inc. 2020. IAF MD 8:2020 International Accreditation Forum, Inc. Issue 4 Application of ISO/IEC 17011:2017 in the Field of Page 2 of 19. Medical Device Quality Management Systems (ISO 13485). The International Accreditation Forum, Inc. (IAF) facilitates trade and supports regulators by operating a worldwide mutual recognition arrangement among Accreditation Bodies (ABs) in order that the results issued by Conformity Assessment Bodies (CABs) accredited by IAF members are accepted globally.
ISO 9001 and scheme specific requirements, where applicable, e.g. ISO TS 22003. The attestations made by CABs at the sub scope level are considered ... The accreditation certificate shall indicate the scope of accreditation which should clearly specify the Technical Areas as defined in Annex 1 – Scope of Accreditation. ...
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