The medical device notified body and ISO registrar Intertek has announced it has formed a partnership with Globizz, a Japanese medical device consulting manufacturing consultancy, in what could be a violation of ISO accreditation standards and international laws. Those regulations prohibit a certification body from providing consulting to its certification clients, or partnering with a consulting company.

Intertek could provide consulting if it put in place controls to ensure it only did so for clients who did not use its certification or testing services. However, an official Intertek press release from June 2021 appears to link those testing and certification services directly with the consulting Intertek plans to offer through the Globizz partnership:

As a testing and certification company, Intertek experts can assist with evaluating products to standards, but the company required a partner to better assist with consultative services in the product development phase.

Globizz will be able to tap Intertek’s extensive technical expertise, as well as testing and certification solutions, for its clients looking to enter the U.S. or Japan, expanding its services and market access.

Per allegations filed with the ISO Whistleblower Reporting program, the relationship with Globizz would violate the European regulation EC 2017/745, which governs the work of medical device notified bodies. Such bodies, which includes Intertek, issue “CE” marks and other certifications for medical devices, and are subject to strict rules related to conflict of interest management. Annex VII of that law restricts Intertek as follows:

1.2.3. The notified body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not … shall not offer or provide consultancy services to the manufacturer, its authorised representative, a supplier or a commercial competitor as regards the design, construction, marketing or maintenance of devices or processes under assessment, and… be linked to any organisation which itself provides consultancy services.

Intertek is also an authorized “Auditing Organization” (AO) under the International Medical Device Single Audit Program (MDSAP) which, in the United States, is managed by the Food & Drug Administration. The MDSAP program has similar restrictions against conflicts of interest.

[Update 11 August 2021: the FDA has confirmed with Oxebridge that is opening an investigation on the Intertek partnership.]

Intertek is also accredited by SCC (Canada), SWEDAC (Sweden), and NABCB (India) to issue ISO 13485 medical device quality system certifications. The rules for that accreditation likewise prohibit a certification body from offering “management system consultancy” services, or linking services to any third-party consultancy. All three accreditation bodies are IAF members, and obligated to enforce rules against conflicts of interest through the IAF regional bodies.

Despite long-standing rules prohibiting certification bodies from performing consulting, and EU laws against the practice, the IAF and its regional bodies have declined to take steps to enforce such requirements. The result has been a rash of certifications issued by bodies who performed consulting on the products or systems they previously helped create.

Oxebridge recently filed a complaint with the IAF against the accreditation body International Accreditation Service which was found to have accredited a number of companies that purchased pre-written management system documentation sold by a Board member of the accreditation body. To date, the IAF has not taken any action to stop the practice, instead rewarding the Vice President of that body with a chair position on its “Task Force on Fraudulent Behavior.”

Japan has been identified by Oxebridge as one of five “international hotspots” for accreditation fraud, largely due to a refusal by the Japanese Accreditation Board to enforce rules and laws on the country’s four major certification bodies. As a result, decades of inspection data falsification have been uncovered, even as the companies involved continue to be rewarded with ISO certifications attesting to product quality. Defective Japanese steel, electronics, and other products have found their way into commercial and military aircraft, automobiles, and consumer products.

The IAF has refused to enforce international laws on its member bodies, and is now itself the subject of an investigation related to potential violations of US and EU sanctions against the Russian firm Rostec.

Oxebridge has written to Intertek for an explanation, but had not received a reply prior to publication.

 

Advertisements

Surviving ISO 9001 Book

Why we report on these topics

Since 2000, Oxebridge has worked to improve ISO and related certification schemes by identifying problems and then proposing solutions. We report on issues affecting standards users because so few other news outlets do. Our belief is that in order to fix the problems in these schemes, we must first understand the nature and breadth of those problems. Our reporting aims to do just that. Elsewhere on the Oxebridge site you will find White Papers and other articles proposing ideas to correct these problems.

Leave a reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Services

Available Tools

Oxebridge SWAG