News & Commentary on ISO Management System Standards

    The IAF Logo on ISO 13485 Certificates is essential

    IAF-logo-300x193 compressed

    The IAF MLA mark is now available to all CABs accredited by The European Cooperation for Accreditation (EA) Members, and be recognised and accepted by all 433 IAF members from 72 countries.

    Importance of the IAF Logo

    The IAF logo is important for medical device manufacturers in countries where their accreditation body is not well known on the world stage. It signifies worldwide recognition without any doubt as to legitimacy.

    The EA, an association of 49 national accreditation bodies in Europe, has completed the administrative requirements of the IAF (International Accreditation Forum) necessary for the extension of their IAF multilateral recognition arrangement (MLA) to include ISO 13485.  This omission has in the past, for example, been a barrier for European medical device exporters in gaining access to markets such as Australia.

    The availability of the IAF logo for ISO 13485 certification means that any conformity assessment body (CAB)accredited by the European accreditation body can apply the IAF MLA mark to their ISO 13485 Certificates.


    Choose an ISO 13485 Course


    Logos Commonly Used in ISO 13485 Certificates in Europe


    Three logos on ISO 13485 certificates are the new normal in Europe:

    1. The CAB logo,
    2. The EA member National Accreditation Body logo and
    3. The IAF logo.

    The Australian Therapeutic Goods Administration (TGA), which previously had refused to recognise the legitimacy of ISO 13485 certificates carrying EA member accreditation, now accepts (according to their website) certificates carrying the IAF MLA Mark.

    Ask your CAB about adding the IAF MLA logo to your existing ISO 13485 Certificate (yes, we've seen Certificates recently where none was present despite qualifying for an IAF logo).  It is not necessary to wait until the end of your current 3-year contract to do so – it can be done at any time.  And may open up new markets for your medical devices or medical device components.


    View our ISO 13485 Internal Auditor Course


    Your follow-up action ...

    If ISO 13485 Suppliers present a Certificate that does not include the IAF logo, you must immediately ask questions as the legitimacy of that Certificate is now in doubt.

    If you own Company's ISO 13485 Certificate does not include the IAF logo, you must immediately ask your CAB to correct 

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    • ISO 21001, Educational Organizational Management System,
    • ISO 29993, Learning Services outside formal Education,  and
    • ISO 29994, Learning Services – additional requirements for Distance Learning.

    We have chosen ISO 21001 certification because, unlike IRCA and Exemplar badges (which in our opinion are commercially compromised), it is based on independent third-party assessment.  It is a ‘university grade’ standard in use globally by schools, colleges, and universities to demonstrate their competence.


    Written by Dr John FitzGerald

    Director & Founder of deGRANDSON Global. Spent 15 years in the manufacturing industry and 25 years training, consulting & auditing management systems
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