The Medical Device Quality Management Systems (MDQMS) scheme has been developed to support accredited certification against the requirements of ISO 13485 - Medical devices – Quality management systems – Requirements for regulatory purposes.   ISO 13485 is a management system standard established to assist organisations that needs to consistently demonstrate regulatory and customer requirements for the delivery of medical devices and related services.

ISO 13485 is based on ISO 9001; but includes some particular requirements for medical devices and excludes some ISO 9001 requirements that were determined not to be appropriate as regulatory requirements.  These differences mean that those organisations certified to ISO 13485 cannot also claim ISO 9001 certification without meeting these additional requirements.

Scheme documents, IAF MD 8 and IAF MD 9, have been developed by the International Accreditation Forum (IAF) .  These documents specify requirements for Accreditation Bodies and Certification Bodies respectively.  IAF MD 9 gives certification bodies further guidance on the requirements of ISO/IEC 17021:2011, including specific competencies for certification body personnel.

The following provides links to the accreditation criteria, accreditation application documentation, and other related documents.  All policies and procedures are un-controlled when printed.  Please read all appropriate accreditation criteria, Procedure 5 (accreditation process), and when ready provide a completed application (with signatures, appropriate application fee, and documentation set) for review. 

Accreditation Criteria

             ISO/IEC 17021 - available from your national standards writing body

IAF MD 9:2011 - IAF Mandatory Document for the Application of ISO/IEC 17021 in Medical Device Quality Management Systems (ISO 13485)

IAF MD 1:2007 - Certification of Multiple Sites Based on Sampling

IAF MD 2:2007 - Transfer of Accredited Certification of Management Systems

IAF MD 3:2008 - Advanced Surveillance and Recertification Procedures (ASRP)

IAF MD 4:2008 - Use of Computer Assisted Auditing Techniques ("CAAT") for Accredited Certification of Management Systems
Note that IAF MD 1 to MD 4 are only mandatory if the CABs certification system provides for certification:
* of multi-sites by sampling, or
* using transfer of accredited certification, or
* applying Advanced Surveillance and Recertification Procedures (ASRP), or
* applying Computer Assisted Auditing Techniques (CAAT).

IAF MD 11:2013 - IAF Mandatory Document for the application of ISO/IEC 17021 for audits of integrated management systems (120 KB)

Procedure 3 - Rules of procedure governing the use of the accreditation symbol (40 KB)

Procedure 11 - Rules of procedure governing accreditation (70 KB)

Policies

Policies introduce or change accreditation criteria.

Policy 03/11 - Transfer of Accredited Management Systems Certification (95 KB)

Policy 4/13 - Introduction of IAF Mandatory Documents MD5:2013 and MD11:2013 (85 KB)

Enclosure 1 for Policy 4/13 - IAF MD5:2013 – IAF Mandatory Document for Duration of QMS and EMS Audits (140 KB)

Enclosure 2 for Policy 4/13 - IAF MD11:2013 – IAF Mandatory Document for the application of ISO/IEC 17021 for audits of integrated management systems (120 KB)

Application Documents

Form 22 - Fee structure (25 KB)

Form 55- MDQMS application form (270 KB)

Form 45 - Information disclosure (50 KB)

Form AUD 107 - ISO/IEC 17021 checklist (930 KB)

Form AUD 34 - IAF MD9 checklist (40 KB)

Accreditation Process

Procedure 5 - The conduct of accreditation assessments (180 KB)

Advisory Notes

Advisory notes do not change accreditation criteria. There are no current advisory notes.

If you require further information please contact us.

Other information

For more detailed information on the standard visit the ISO website.

This page is written for CABs interested in gaining accreditation. If you are an organisation interested in gaining certification for this scheme contact an accredited CAB for further information. A list of CABs accredited for MDQMS is available here.