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.

This document follows the structure of ISO/IEC 17021-1. IAF specific criteria are identified by the letter “MD” followed with a reference number that incorporates the related requirements clause in ISO/IEC 17021-1. In all cases a reference in the text of this document to “clause XXX” refers to a clause in ISO/IEC 17021-1 unless otherwise specified.

This 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.


Application of ISO/IEC 17021-1 in the Field of Medical Device Quality Management Systems (ISO 13485)