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. This is important for medical device manufacturers in countries where their accreditation body is not well known on the world stage. The IAF logo 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.
So three logos on ISO 13485 certificates are the new normal in Europe:
- The CAB logo,
- The EA member National Accreditation Body logo and
- 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.
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
Our ISO 13485 training courses include ...
- Is IAF Accreditation Possible for All ISO Standards?
- IAF Mandatory Documents Your Accreditation Body Can Require
- ISO 13485 Certification: 26 FAQs answered
- ISO Accreditation vs ISO Certification: Which Do You Need?
deGRANDSON Global is an ISO Certified Educational Organization
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.