In October, pharmaceutical company Petrovax Pharm confirmed its Quality Management System (QMS) conformity to ISO 9001:2015 (GOST R ISO 9001-2015).
The Certificate of Conformity for the QMS is issued by the Russian Register Certification Association, the Russian largest internationally renowned certification and expert organization, based on the certification audit findings.
In addition to Master ISO 9001:2015 Certificate, Petrovax Pharm is also issued a IQNet unified international certificate.
IQNet is an international certification network, a private nonprofit organization established in accordance with the Swiss legislation. It is the largest and ultimate international network of partner certification bodies.
Petrovax Pharm pays close attention to the QMS first implemented and certified to ISO 9001:2000 (GOST R ISO 9001-2001) in May 2005. The company’ QMS undergoes oversight inspections by an appropriate certification body on an annual basis; every 3 years, the QMS undergoes a large-scale recertification audit. The presence of a stable QMS conforming to ISO 9001 laid the foundations for the implementation of GMP EU and GMP RF standards.
A successful validation of QMS conformity to ISO 9001:2015 (GOST R ISO 9001-2015) as well as the issuance of the IQNet unified international certificate provides for Petrovax Pharm’s greatest recognition as a quality biopharmaceutical manufacturer.
About ISO 9001:2015
The new ISO 9001:2015 version, Quality management systems – Requirements, developed by the International Standardization Organization, came into effect on 01.11.2015. In the Russian Federation, the national standard GOST R ISO 9001-2015 was adopted based on ISO 9001-2015 (an authentic ISO 9001:2015 translation). ISO 9001:2015 (GOST R ISO 9001-2015) includes certain key changes vs. the earlier version, i.e. ISO 9001:2008 (GOST ISO 9001-2011), and makes new, much tougher requirements to the QMS. In particular, it proposes a risk management model, improves approaches to company’s competences through the implementation of knowledge management, and development of a company’s knowledge base. The new quality management principles focus on management leadership and the implementation of a process-based approach.