Bureau Veritas has received a formal complaint issued by Oxebridge after allowing a Peruvian pharmaceutical company to mark their products as being ISO 9001 certified.
Instituto Quimioterapico S.A., which trades under the name “IQFarma,” has routinely put an ISO 9001 mark on both outer and inner packaging for drugs sold under its brand. These are then sold throughout Peru at brick-and-mortar pharmacies and online.
IQFarma is certified to ISO 9001 by Bureau Veritas, and IAF CertSearch reports that the UK office was the governing body for that certification. The certificate was issued under the UKAS logo.
Bureau Veritas is accredited by UKAS under ISO 17021-1 for the issuance of management system certifications, including ISO 9001. That standard prohibits the placement of the ISO 9001 mark in any way that implies the product, and not the management system, is certified:
[The] mark shall not be used on a product nor product packaging nor in any other way that may be interpreted as denoting product conformity.
A certification body shall have rules governing the use of any statement on product packaging or in accompanying information that the certified client has a certified management system. Product packaging is considered as that which can be removed without the product disintegrating or being damaged.
Per Bureau Veritas’ own procedures on the use of its mark, the usage by IQFarma would be in violation. That policy requires that the mark only be used on outer packaging used to transport the product, not on inner packaging, and that even then, it must include a statement clarifying that the management system — and not the product — is certified.
Nevertheless, IQFarma has been certified by Bureau Veritas since at least 2013, when BV issued the company a certification to the prior standard, ISO 9001:2008, which was current at that time.
It is unclear how Bureau Veritas could have allowed IQFarma to violate the product marking rules for so many years and then distribute their products throughout the entire country without ever discovering the practice, despite annual surveillance audits.
Oxebridge attempted to file a complaint using Bureau Veritas’ online complaints form, which repeatedly failed. This represents another violation of ISO 17021-1 by Bureau Veritas, as that standard requires the company to have a means of processing complaints.
Only after contacting the US office was a point of contact at the UK office obtained, and a complaint was sent via email. The UK office then responded by saying the matter was likely managed by its Colombian office and claimed to have forwarded the issue to them. There has been no further communication from Bureau Veritas from any country on the complaint.
Bureau Veritas has a strong and powerful presence in Peru and other countries in the South American region and enjoys near total impunity for its actions. For years it certified Odebrecht, which was found to be responsible for “Operation Car Wash,” the largest bribery scandal in modern history. The former resident of Peru, Alan Garcia, committed suicide when police arrived at his house to arrest him for allegedly accepting bribes from Odebrecht. Despite this, Bureau Veritas awarded an Odebrecht executive with a Director position and continued to issue certificates to the company.
Even though Bureau Veritas enabled the Operation Car Wash scandal to proliferate under the guise of respectable ISO certifications, and that this ended with the suicide of its former President, the Peruvian government and officials have refused to hold Bureau Veritas responsible. Instead, BV enjoys a special status in the country as one of two major CBs operating there, alongside rival SGS. The ISO 9001 mark is found routinely on products sold in Peruvian shops, and neither the Peruvian accreditation body INACAL nor their international partners take action to stop the practice.
