For over a month, Bureau Veritas has ignored a complaint related to its certification of the Peruvian pharmaceutical company Instituto Quimioterapico SA, also known as IQFarma. Oxebridge previously reported that IQFarma has been placing an ISO 9001 mark on its products, in violation of ISO 17021-1. Official records in IAF CertSearch show IQFarma was certified by the UK office under the accreditation of UKAS.

Oxebridge alleges that Bureau Veritas (BV) refuses to enforce the rule against marking products with an ISO 9001 mark. BV has certified IQFarma for many years, suggesting IQFarma must have undergone multiple annual surveillance audits, and yet BV took no action against the packaging practices. Making matters worse, the mark appears on drugs, suggesting the products themselves are certified. ISO 9001 is a system certification and is not intended to indicate certification of products.

Oxebridge attempted to file a complaint using the form found on the Bureau Veritas website, but this form did not function. Since Bureau Veritas does not publicly provide any email addresses for complaints, this initially shut down the matter before it started. That in itself is another violation of ISO 17021-1. Oxebridge then contacted the US office of BV, obtained an email address, and resubmitted the complaint to the UK home branch.

The UK office then claimed that the Colombian office of BV had issued the certificate and that they would be in contact about the matter shortly. This appeared to contradict the official certificate information found in CertSearch and ignored the fact that BV has an office in Peru. Oxebridge then contacted the UK office to alert them to these issues, but BV cut off communication on the matter entirely.

Oxebridge then sent the complaint to the Peru office, in Spanish. That office also ignored the complaint.

It is now unclear what office of BV actually issued the certificate since the Peru office operates under accreditation by INACAL and not UKAS. The Colombian office operates under that country’s AB, ONAC.

On March 8th, Oxebidge warned BV that any further delays would result in an escalation being raised with UKAS. Again, bureau Veritas ignored the issue.

Oxebridge has now escalated the matter to UKAS and is demanding that the accreditation body not only investigate BV’s failure to uphold the restrictions on ISO 9001 product marks for IQFarma but also probe BV’s refusal to process a formal complaint.

Bureau Veritas is one of UKAS’ largest customers, so it is unlikely that the UK accreditation body will take action despite requirements under UK law and ISO 17011 to do so. UKAS has routinely flouted its obligations, as it remains protected by key figures in the UK government.

The issue was also copied to the IAF and its European regional body, EA.

The scandal shows just how little control the IAF has over the ISO accreditation scheme, as it prepares to merge with the laboratory accreditation oversight body ILAC and form “GLOBAC.” GLOBAC aims to control all such accreditation worldwide.

 

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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.