Quality

1. Name and address of the organization certified

2. Scope of certification describing its activities under certification – e.g. production, packing and sale of ……… like …….(broad list of products)

3. Standard (or sometimes scheme or regulation) against which certification is granted e.g. ISO 9001 or ISO 13485 (standard) or ICMED 13485 (scheme) – in general
   guidance standards (e.g. ISO 10002 or ISO 31000) are not amenable to certification – these have to be formal requirement standards or specifications or regulations.

4. Date of issue and expiry of certificate

5. Unique identification number of the certificate

6. Name and address of the certification body (CB)

7. Logo of the certification body

8. Accreditation symbol indicating the name of the accreditation body (AB) which has accredited the certification body (in most countries, in the absence of any law requiring certification bodies to register, accreditation is the only way of recognizing a competent, authentic certification body)

9. IAF Mark – indicating that the certificate is covered under the Multilateral Mutual Recognition Arrangement (MLA) of the International Accreditation Forum (IAF) and
   hence is internationally equivalent and acceptable in the market.

How to Check Authenticity

To check the validity of ISO 13485 certificates, you need to follow the steps given below :

1. Get a copy of the MDQMS certificate

2. Check whether the certificate has the logo of the certification body (CB) and the accreditation body (AB). If it does not have logo of the AB, its unaccredited certificate and even if legally valid, it would not be part of international system and the certification agency is not under any oversight. Request your certification agency to issue an accredited certificate or change your certification agency.

3. If the certificate carries logo of AB also, check if the AB is part of the IAF (International Accreditation Forum) system – its name can be checked from IAF website
   for each country. If the AB is listed there, the certificate is likely to be genuine. If not, the certificate is not authentic and seek an authentic certificate under IAF system.

4. Check whether it carries the logo of IAF; you can find the sample image of logos in IAF website. If YES the certificate is likely to be genuine and indicates it is internationally equivalent. if NO the certificate may not be internationally equivalent. Note that use of IAF Mark is optional and its absence does not necessarily mean the certificate is not internationally equivalent.