IAF MD 9:2011 and the Impact on Audit Duration for Medical Device Manufacturers

The International Accreditation Forum (IAF) has issued a new Mandatory Document for the Application of ISO/IEC 17021 in Medical Device Quality Management Systems (ISO 13485), the IAF MD 9:2011.

 The MD 9:2011 has entered into force July 2012, and the main requirements of this guideline relate to:

  • The experience competences for auditors which have been defined in more detail than previously, especially with respect to the clinical and risk aspects of devices.
  • Audit time has increased – especially for small and medium size manufactures


For more information about the IAF MD 9:2011 please go to:


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