Certificates
The target of the company management is to achieve a permanent mutual confidence between the company and its partners as well as the sense of co-responsibility of all employees for quality of products and the stable good reputation of the company.
For this purpose, an integrated quality management system has been implemented in the company, the system corresponding with the provisions of the international regulation ÈSN EN ISO 9001:2000. In the quality management system, the requirements of good manufacturing practice (GMP), requirements of regulations for medical devices (ÈSN EN ISO 13 485), for environment (ÈSN EN ISO 14 001) and for occupational safety and health protection (OHSAS 18 001) have been included into the requirements of this basic regulation. The said international regulations represent a recognized standard both in Europe and worldwide increasing the credibility of the supplier.
The implemented integrated quality management system includes all significant company procedures and activities from ascertainment of the customer’s requirement, through proposal and development of a new or innovated product, its production and control to handover of the product to the customer including the related servicing activities.
The history of the integrated quality management system implementation by the company started in the year 1999. In the spring of 2000, the company was certified for the first time by the foreign organization SGS Yarsley International Certification Services. In the course 2003, the management system was adjusted to the requirements of the ÈSN ISO 9001:2000 regulation and requirements of the management of environment and work safety were included in the system. In the autumn of 2003, the integrated system was certified by the companies SGS United Kingdom Ltd. and SGS Société Générale de Surveillance SA Switzerland.
The integrated quality management system is continuously developed and its functions, efficiency and effectiveness are regularly reviewed by internal audits, audits of contractual customers, inspections of GMP state authorities as well as independent certifying organizations.
The company possesses certificates pursuant to the regulations:
- ISO 9001:2008 Quality Managements Systems,
- ISO 13 488: 2003 Medical Devices Quality Managements Systems,
- ISO 14001:2004 Environmental managements systems,
- OHSAS 18001:2007 Occupational health and safety managements systems,
- CE 120, ,
- Certificate of good manufacturing practice (PDF),
- Certificate of good manufacturing practice ,
- Certificate for production of veterinary preparations,( str. 1 , str. 2 ),
- Certificate for production of human drugs, ( str. 1 , str. 2 ).
Company AVEFLOR issued Quality, environmental and occupational health and safety policy, for years 2006-2007 which you can see here( str. 1 , str. 2 ) or download here in PDF format.
