The Role of International Accreditation in Management System Certification


Total number of ISO QMS certificates as of 2022. Table derived from the “ISO Survey 2022.”

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In 2019, the pandemic began to take its toll on the world. At the same time, IAF launched IAF CertSearch to help companies and agencies validate ISO certificates being shown them by potential vendors. By 2020, many governments were pressed hard for medical devices and personal protective equipment. Thermometers, respirators, and test kits were in short supply as billions of citizens were endangered by Covid-19. Test kits and PPE were flooding across borders with ISO certificates supporting their claims of quality but with no way to verify whether those certificates were legit. The United Kingdom was first to use IAF CertSearch to screen ISO certs that accompanied personal protective equipment (PPE) that was in highest demand.

Published: Thursday, March 7, 2024 – 12:02

The deadline was set for Oct. 26, 2024, for accredited certification bodies to upload their certificates. After this date, any certification body that hasn’t cooperated may be subject to losing their international accreditation, which would invalidate all their clients’ ISO certificates. This is a critical move intended to solve a most serious worldwide problem.

Eroding the use of fake and invalid certificates

Also in 2019, the U.S. Food and Drug Administration allowed devices free movement across the border using ISO 13485 certificates under provisions of the Emergency Use Authorization Act, again with no way to conveniently validate those certs.

Standards

The Role of International Accreditation in Management System Certification

There’s a lot below the surface of an ISO QMS certificate

On Oct. 26, 2023, the IAF reached consensus by worldwide vote that the database would be mandatory. The expectations are presented in IAF MD28:2023, “IAF Mandatory Document for the Upload and Maintenance of Data on IAF Database.” MD:28 prescribes the requirements for accreditation bodies and conformity assessment bodies that operate within the IAF framework for uploading all of their ISO certificates that have been issued, along with other data relevant to supporting IAF CertSearch.

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Accreditation bodies that are members of the IAF have to meet international requirements established in the accreditation standard ISO/IEC 17011 “Conformity assessment—Requirements for accreditation bodies accrediting conformity assessment bodies.” In turn, accreditation bodies assess certification bodies using ISO/IEC 17021 “Conformity assessment—Requirements for bodies providing audit and certification of management systems.”

The IAF is primarily an organization representing accreditation bodies that assess the certification bodies that issue ISO certificates to companies that have shown conformance to various ISO QMS standards.

At this same time, two ministries of health from the Middle East learned of IAF CertSearch and submitted all of the ISO 13485 certificates they had; only half of them were found to be valid. 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 chairman of IAF pleading for the IAF to make IAF CertSearch mandatory worldwide. Suddenly IAF CertSearch and its team of employees were thrust into a war on fake certificates.

The IAF members participating in the IAF multilateral recognition arrangement must also participate in peer evaluations and regional assessments, and must satisfy many more requirements laid down by the IAF in IAF mandatory documents—all of which further ensure that impartial audits and assessments are conducted by competent personnel.

Like the tip of an iceberg, a valid ISO certificate is supported by many documents and processes hidden beneath the surface. The world rarely looks below that surface to understand what makes certificates valid. Less scrupulous organizations, and some that simply don’t know any better, can end up paying for audits that aren’t of the same caliber.

The database is intended to be updated by the certification bodies, which must be accredited by an accreditation body of the IAF. This ensures that only IAF-backed certificates are uploaded. It has taken five years to grow, learn, and refine the database to support so many certification bodies and their 2.4 million certificates. The IAF has now decided to make certification body participation in the database mandatory.

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ISO QMS standards are doing some of the heaviest lifting of some of the world’s most difficult problems. By 2025 it’s expected that IAF CertSearch will make it too difficult to use invalid certificates. It will also place on a pedestal those 2.4 million organizations that have risen to the top of the ISOberg to get the recognition and business they deserve.

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As of its 2022 ISO Survey, ISO reported that there were 2.4 million valid quality management system (QMS) certificates issued to the 16 most critical QMS standards. Their validity is determined by the fact that they are accredited by members of the International Accreditation Forum (IAF) who are also participants in the IAF multilateral recognition arrangement (MLA). The IAF MLA is an agreement that holds IAF members accountable to special IAF assessments that reward an accreditation body—and all certificates that bear their accreditation mark—with an international recognition that all other members of the IAF must accept.

Understanding the ISOberg of international accreditation

When it comes to protecting anyone or anything from harm caused by something manufactured, grown on a farm, or rolling down a highway or a runway, quality is of utmost importance. Our trust forms the backbone of what we expect from our food, cars, planes, medical devices, and protection of the environment.