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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. Accreditation reduces risk for business and its customers by assuring them that accredited CABs are competent to carry out the work they undertake within their scope of accreditation.

ISO/IEC 17011:2017 continue to apply and this document provides additional criteria to that standard. This mandatory document is exclusively for accreditation of bodies certifying to ISO 13485. 0. INTRODUCTION ISO/IEC 17011:2017 is an International Standard that sets out the requirements for

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