14 October / 2020

Sintez's QMS Compliance Validated

In the second half of 2020, JSC Sintez has received a certificate attesting that the company's quality management system has been examined and recognized as compliant with the requirements of the GOST ISO 13485-2017 (ISO 13485:2016) standard pertaining to the development, production, storage, and distribution of medical devices: exfusion, infusion, transfusion devices, lines, catheters, containers for blood and blood components, containers for infusion solutions.

The certificate attests that the following product lifecycle processes are compliant with the GOST ISO 13485-2017 standard: process planning (clause 7.1.), customer-related activities (clause 7.2.), research and development (clause 7.3.), procurement (clause 7.4.), production and maintenance (clause 7.5.), equipment management for monitoring and adjustments (clause 7.6.).

Every year, JSC Sintez manufactures approximately 11 million medical products made of polymer materials, including unique containers for donated blood and blood components, etc.