Nacimbio Confirms Its Quality Management System as Compliant with National and International Standards

Rostec State Corporation Nacimbio Holding successfully passed an independent inspection audit of its quality management system (QMS), which confirmed that the services in the field of procurement, storage, transportation, and sale of medicinal products and medical devices offered by the company are compliant with the national and international requirements of GOST P ISO 9001-2015 and ISO 9001: 2015.

The company noted that the Nacimbio QMS has been in place since 2019. This is the second certification cycle for the holding. To comply with Russian and international standards, Nacimbio pays special attention to the use of a process approach, risk management, and increasing customer satisfaction.

The audit covered every aspect of the organization regarding procurement, storage, transportation, and sale of medicinal products and medical devices. In particular, the audit proved that the QMS is effective, documented processes function correctly, corrective and preventive actions are implemented on time, and internal audits and personnel training are completed regularly. As auditors have noted, the corporate QMS is resilient, among other things, due to the active involvement of the company’s management and the high competence of employees in matters of QMS operation.

“Compliance with national and international standards is further evidence of scrutiny that we utilize with regard to our products and services’ quality. We use modern equipment when transporting and storing our products and continuously monitor cargo movement and control temperature,” the company representative said.

Nacimbio is one of the largest manufacturers and suppliers of pharmaceuticals in Russia, which provides about 90% of vaccines for the National Preventive Immunization Schedule (NPIS). Annually, the list of supplies includes on average up to 20 types of vaccines from Russian manufacturers. The company has been supplying vaccines for the NPIS since 2015, having sent more than 1 billion doses to the regions throughout the period.