COVID-19 has led to an increase in the demand for personal protective equipment (PPEs) in the country. This has led to the provision of inauthentic and fraudulent certificates provided by PPE suppliers to purchasers, including government procurement agencies.
According to accrediting agencies and market sources, this course of action has put the frontline healthcare workers’ lives at risk.
The Indian market is full of private certification bodies which issue fake certificates to industries. It is difficult yet important to distinguish an authentic certificate from the inauthentic and fake ones.
‘The quality of PPE is at Centre stage now. The union health ministry has also specified standards and reports acceptable from national and international organizations and labs which has led to all kinds of certificates in the market, most of them inauthentic and some may even be fraudulent,’ says Anil Jauhri, former CEO, National Accreditation Board for Certification Bodies (NABCB).
There are certificates for CE mark and ISO standards. While notified bodies (NB) of European Commission (EC) can only issue CE certificates, ISO certificates are those which come from duly accredited CBs and carry the logo of the accreditation body (AB) under the prevailing international system.
As Mr Jauhri conveyed, ISO is only a standard-setting body and does not undertake any certification. Hence, the use of an ISO logo in any form on a certificate is a misuse and shows inauthenticity.
In India, certification bodies should be accredited by NABCB for undertaking certification as per ISO 13485, an international standard for quality management systems (QMS) in medical devices, also accepted by many regulators around the world.
NABCB under Quality Council of India (QCI) is the national accreditation body in India. Any certificate bearing NABCB logo should be acceptable because it indicates the issuing of a certificate by a competent and recognized body.
‘It may also be noted that the CE mark is Europe’s regulatory mark and in case of PPEs, EC has a separate regulation under which Notified Bodies are designated only in Europe. There may be some branches or associates of NBs in India, but any certificate must be from the NB listed in the European Commission database,’ he further informed.
Click here to view the list of Notified bodies under EC.
The total projected demand of PPE kits till June 2020 stands at an estimate of Rs. 2.01 crore. Around 107 PPE manufacturers have raised their daily production to about 1.87 lakh PPE kits.
Name and address of the organization certified
Scope of certification describing its activities like production, packing and sale of PPEs like coveralls, shoe covers and more
Standard (or sometimes scheme or regulation) against which certification is granted like ISO 9001 or ISO 13485 (standard)
Date of issue and expiry of the certificate
Unique identification number of the certificate
Name and address of the CB
Logo of the CB
Accreditation a symbol indicating the name of the accreditation body (AB)
In most countries, with the absence of a law requiring Certification Bodies to register, accreditation is the only way to recognize a competent and authentic certificate.
The International Accreditation Forum Mark (IAF) is an optional standard which shows the certificate is covered under the Multilateral Mutual Recognition Arrangement (MLA) of the IAF, hence, making it internationally equivalent and acceptable in the market.
Further, to judge the authenticity, one can see the names of member Accreditation Bodies of IAF on its website which also gives information on which accreditation bodies are signatories to IAF.
Once the user locates the AB in a country, he/she can visit the AB and IAF website to verify if it accredits the Certification Body. Here on, they can verify the certificate because as per international norms, CBs must help verify certificates issued by them.
The pandemic has led to a rise in these fraudulent certifications by unregistered Certification bodies. The current scenario mandates the verification of these certificates to ensure authenticity. One can undertake these measures to distinguish verified suppliers and work with them.