Grant Ramaley
Director of Regulatory Affairs
Aseptico Inc.

When it comes to protecting anyone or anything from harm that can come from something manufactured, grown on a farm, rolling down the highway or our runways, the ‘quality’ of things is of utmost importance. Our trust forms the backbone of what we expect from our food, cars and planes, protection of the environment and much more.

In the results of its most recently published ISO Survey, the International Organization for Standardization (ISO) reported that there were 2.4 million valid management system certificates issued to 16 of these most critical management system standards. As a requirement for validity, the issuing certification body must be accredited by an IAF Member signatory to the IAF Multilateral Recognition Arrangement (MLA).

Yet most of the 2.4 million organizations that hold these certificates do not know the mountain of work that keeps their certificate afloat, accepted worldwide.

IAF MLA signatories must undergo peer evaluations and regional assessments, and satisfy requirements included in IAF Mandatory Documents, as well as comply with relevant international standards governing all accreditation activities worldwide. That work assures audits and assessments are conducted by competent personnel also protecting the certification work from concerns of partiality. 

Although there is a pyramid shape to the number of documents that support a valid ISO certificate, the world rarely looks below the surface and does not see or comprehend what makes their certificate valid. And to make matters worse, less scrupulous organizations and some who simply do not know any better can end up paying and supporting audits that are not steadied above so much oversight and accountability. They appear ‘On the surface’ like all others.

IAF CertSearch – The World’s First International Database for ‘Valid’ ISO Certs

Since 2019, IAF has been working with an Australian firm to manage an international database containing management system certificates issued by certification bodies accredited by IAF MLA signatories. As of 2024, it holds roughly half of those 2.4 million certificates. The team at www.iafcertsearch.org  currently detects an estimated 20,000 fake certificates per year!

The database ensures that only IAF-backed certificates are uploaded. It has taken five years to grow, learn and refine. On 26 October 2023, the IAF reached consensus that the database would be mandatory beginning 26 October 2024, to address the need for a fully populated database.

Eroding the Use of Fake and Invalid Certificates, Especially in Healthcare

In 2019, the COVID-19 pandemic began to take its toll on the world. In the same year, IAF launched IAF CertSearch to help validate ISO certificates.  By 2020, many governments were hardpressed to obtain sufficient medical devices and personal protective equipment (PPE). Thermometers, respirators and COVID-19 test kits were in short supply as billions of citizens were endangered by COVID-19.

The United Kingdom was first to use IAF CertSearch to screen ISO certificates that accompanied PPE in highest demand. COVID-19 test kits and PPE were flooding across borders, with ISO certificates supporting their claims of quality. 

The United States’ Food and Drug Administration (FDA) allowed devices free movement across the border using ISO 13485 certificates under provisions of the ‘Emergency Use Authorization Act’.  Suddenly IAF CertSearch was thrust into a war on fake certificates.  

At the same time, two Ministries of Health from the Middle East learned of IAF CertSearch and submitted all of the ISO 13485 certificates. Only half of the certificates they held at their ministries of health were found to be credible. Shortly thereafter a letter from the largest group of medical device regulators in the world, the Global Harmonization Working Party, sent a letter to the IAF Chair encouraging IAF to make participation in IAF CertSearch mandatory worldwide.   

The Health and Wealth of Humanity are Supported by IAF CertSearch

Soon after becoming aware of the effectiveness of IAF CertSearch, Space-X, Airbus and automotive industry representatives sent letters asking IAF to enforce upload of all relevant certificates. More letters arrived from financial institutions and even the US Department of Energy, which was working on a new global initiative to use ISO 50001 to improve energy management became ardent supporters.

Today, new management systems are being developed to eliminate problems with our environment, support the sustainability of our forests, food supply, water quality and the air we breathe. By 2025, it is expected IAF CertSearch will make it too difficult to use fraudulent certificates. It will also place on a pedestal those 2.4 million organizations that have risen to the top of the ISO-Burg and earned the recognition they deserve.

16 key ISO management system standards are noted below, along with the number of certificates for each in the last published ISO Survey results. IAF Members play a key role in supporting these certifications.  And now, with IAF CertSearch accessible to anyone in the world, perhaps more people will begin to peek below the surface.