Certificates

The archived About page and the company LinkedIn page claimed ISO 13485 from QS in Switzerland and ISO 9001:2015. Those claims are on padtan.com, rebuilt.

ISO 9001 is a quality-management certificate. A registrar audits how a factory runs its paperwork and process. It is not a product approval. It is not a United States FDA clearance. ISO 13485 is the same idea written for medical devices. It says the quality system is built for devices. It does not mean a kit is cleared for sale in Europe or the United States. IMED is Iran’s medical-device office. A listing there is the domestic license track. IVD is in-vitro diagnostics: a test run on a sample outside the body. ELISA is a plate-based immunoassay. Those kits are the product this company sold.

Iran is a sanctioned market. Ordinary Western banking, export, and OEM paperwork is harder there than for a British or Swiss kit maker. That is context for why a domestic ISO claim and an IMED listing matter on this file. It does not prove a secret Thermo Fisher or Roche contract. Thermo Fisher’s own public language from that period said the company had a policy against Iran transactions. Iranian distributors still advertise Thermo kits. Both facts sit on Alleged deals. Neither names this company as a party.

Pathobiology Laboratory Center prints quality marks of its own, including ISO 9001:2015. ISO 9001 is not ISO 15189. Those faces belong to the laboratory. They are not Padtan Elm’s QS claim, and they are not a registrar file for this company.

The certificate PDFs, the registrar file numbers, and the dates of issue are not in this warehouse. The issuer printed on the About page is QS, Switzerland.