Featured Product
This Week in Quality Digest Live
FDA Compliance Features
Emily Newton
Technology and processes improve food quality and purchaser trust
Janet Woodcock
A flexible approach for ensuring access to safe, high-quality food and medical products
Clare Naden
One way is through a system of conformity assessment to ISO standards
Sheronda Jeffries
Inclusion of ISO 13485 certificates in IAF CertSearch could help protect first responders

More Features

FDA Compliance News
Free education source for global medical device community
Good quality is adding an average of 11 percent to organizations’ revenue growth
Further enhances change management capabilities
Creates adaptive system for managing product development and post-market quality for devices with software elements
VQIP allows for expedited review and importation for approved applicants that demonstrate safe supply chains
An invite from Alcon Laboratories
Intended to harmonize domestic and international requirements
Pharma quality teams will have performance-oriented objectives as well as regulatory compliance goals

More News

Sheronda Jeffries

FDA Compliance

More Must Be Done to Promote IAF CertSearch

Inclusion of ISO 13485 certificates in IAF CertSearch could help protect first responders

Published: Wednesday, January 27, 2021 - 13:02

Since the beginning of the coronavirus outbreak, UK officials have seized millions of substandard face masks at Heathrow Airport. These masks could have put millions at risk for contracting or spreading the Covid-19 virus.

Industry and governmental organizations including the Therapeutic Goods Administration (TGA)—a member of the International Medical Device Regulators Forum (IMDRF), which participates in the U.S. Medical Device Single Audit Program (MDSAP); the Australian Government Department of Health; the Chairman of the Global Harmonization Working Party; and others have contacted IAF CertSearch requesting information on how to verify the validity of ISO 13485 certificates.

IAF CertSearch is the world’s only global database for accredited management system certifications, providing businesses and governments the ability to digitally validate an organization’s certifications to determine if a certificate is valid and if the certification body issuing the certificate is accredited to issue certifications to that standard.

More than ever, we need to have confidence in accredited certification, and IAF CertSearch is helping. Thousands are utilizing the database each month to verify certifications, and the number of users is increasing month by month.

However, more must be done to promote IAF CertSearch and how it can help provide regulators and industry across the globe a fast, reliable, single source of truth.

For example, as of December 2020, the Telecommunications Industry Association’s (TIA) QuEST Forum now requires all of its TL 9000 certification bodies to activate their accounts within IAF CertSearch. Without certification body account activation, a certified organization’s certificate is not searchable within IAF CertSearch, even if the certificate information is included within the database. TIA QuEST Forum’s requirement for certification body account activation could ultimately impact not just the information and communications technology (ICT) or telecom industry but other industries as well.

Although one large certification body in the United Kingdom responded that “respectively this is not a priority,” it should be. Regulators verifying personal protective equipment (PPE) and organizations with global supply chains are seeking to utilize IAF CertSearch to verify whether a certified organization’s certificate is fraudulent.

For example, inclusion of searchable ISO 13485 certificates in IAF CertSearch could help protect our first responders from contracting Covid-19 through the use of substandard PPE. This is a relatively small task that could make a big difference protecting healthcare workers as they work to protect others around the globe.

If you have a concern regarding a management system certification that you believe may be counterfeit, please contact IAF CertSearch. The IAF is investigating scams, informing relevant organizations such as accreditation bodies and certification bodies of such scams, and keeping records. IAF CertSearch is also interested in learning about companies claiming to maintain IAF-accredited management system certification when their certificates may be suspended, withdrawn, or expired.

You may contact IAF CertSearch to request that your organization be included in IAF CertSearch or to send any concerns you have regarding IAF-accredited certification by using the contact form at www.iafcertsearch.org/contact.


About The Author

Sheronda Jeffries’s picture

Sheronda Jeffries

Sheronda Jeffries is an industry leader at TIA QuEST Forum, an industry collaboration of companies dedicated to ICT supply chain quality and performance. As TIA QuEST Forum’s representative, she represents the ICT industry at global collaboration organizations including the USTAG TC, ISO TC 176, ISO CASCO STAR and the IAF, where she serves as the Director representing Users and Industry and the Chair of the IAF User Advisory Committee.