Verifying authenticity of ISO 13485 certificates for Medical Devices

Anil Jauhri

Ex-CEO, NABCB

jauhrianil@gmail.com

+919810567765

0. INTRODUCTION

The world market is full of private certification bodies issuing certificates to industry and it is important to distinguish an authentic certificate from many unauthentic, fake or even fraudulent certificates going around. Unfortunately, there is a plethora of unauthentic ISO 13485 certificates in the medical device sector which should get weeded out with the stipulation of accredited certificate under IAF system by CDSCO for voluntary registration. Until then the industry and users need to be wary of such unauthentic certificates.

1. CONTENTS OF AUTHENTIC CERTIFICATE

An authentic certificate should contain the following:

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

2. 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 www.iaf.nu 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.

5. IAF is creating a database of certificates – see link https://www.iafcertsearch.org/ - you can verify your certificate on this website. However, this database is new and is in the process of being developed – so absence on this website does not mean your certificate is not genuine.

6. All CBs are authorized to issue certificates for Standards and Scope Sectors for which they have been accredited by the respective ABs.

7. The national AB in India is NABCB. Currently, NABCB provides accreditation for a number of management systems standards which includes ISO 9001 as well as ISO 13485.

8. Go to NABCB website and click on ‘Accredited CBs and IBs’; select ‘MDQMS’ from the list.

9. You will be able to view the list of CBs accredited by NABCB. The list has 11 names currently. Are you able to find the name of the CB of your interest? If YES, go to next Step; if NO go to Step 11.

10. Click on the name of the CB selected and look for the following 2 facts:
    1. Whether the CB is authorized to certify for Scope Sector in which your activity falls; and
    2. The date on the MDQMS certificate issued is within the date range of ‘Valid from’ and ‘Valid upto’

If it meets both these conditions, the certificate is VALID.

11. It is likely that the CB is authorized by an AB of some other country as ascertained in Step 4.

12. In such a case, go to the AB’s website as given on IAF website and repeat steps 8 to 10 by clicking on the name of the CB.

13. Each CB has to provide a means of verifying its certificates – you can use the mechanism to verify that the certificate is in CB’s database especially if your certificate has been issued through a franchisee of a foreign CB.

14. Some ABs also provide a means of verifying certificates issued under their accreditation – you can check on the concerned AB website.

16. In case you still have doubt, refer the copy of the certificate to NABCB for verification at nabcb@qcin.org. It will help you verify even from foreign AB member of IAF.

Note: The same approach applies to verifying ISO certificate for any management systems standard say ISO 9001 or ISO 14001.