Supply RU certified against ISO 9001
Based on SGS audit results, Supply RU LLC quality management system has been recognized to be compliant with ISO 9001:2015. Supply RU is member of the SMO Group, the global clinical trial logistics provider.
SMO Group has been systematically audited against ISO 9001:2015 to guarantee continuous patients’ access to innovative medicines around the world in due time and in full compliance.
The current global SMO Group’s quality management system provided strong basis for ISO 9001 implementation in Russia. Still, when the Russian subsidiary started activities new challenges arose.
Implementation of the quality management system took about a year. When ensuring compliance with the standard special attention was paid to the following issues:
- Transition from a local vision to the global strategy
- Implementation of a matrix management structure
- Ensuring correct values are assumed by local employees, adoption of a patient-focused approach
Anastasiya Shtro, Director General of Supply RU LLC: “Compliance with quality management international standards is an important indicator of a company’s reliability, especially when this company’s activities directly influence health and well-being of people in need of medical assistance. We seek to continuously improve our service quality management processes and intend to further implement the process-based approach to ensure necessary flexibility to comply with clinical projects market changes and new advanced therapy solutions”.
Yana Yampolskaya, Management Systems Certification Manager at SGS Vostok Limited (Member of the SGS Group): “Supply RU pays great attention to staff development by conducting different internal and external trainings. This is an important part of a quality management system. Appropriate infrastructure, use of modern equipment, duplication of all key functions have also positive impact on QMS effectiveness”.
Starting from 2004, SMO GROUP operates as a specialized clinical trial logistics provider. The company partners with major international pharmaceutical companies, contract research organizations and medical products manufacturers in order to provide clinical sites with products to be tested, equipment and support materials in the CIS, Middle East, Africa and the Balkans.
SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With more than 94,000 employees, SGS operates a network of over 2,600 offices and laboratories around the world.