The quality and customer satisfaction is the most important to us
Our customers' satisfaction and fulfilled expectations are our main objective. For this reason, in addition to our wide range of services and options, ERBI Group ensures the highest quality of manufactured packaging and leaflets. The implemented Integrated Management System and application of good manufacturing practice (GMP) ensure that our products conform with strict requirements imposed by the pharmaceutical industry.
Quality is monitored during each manufacturing stage, which allows us to minimise mistakes. Each produced lot has an individual quality certificate and the customer always receives a representative sample. We have implemented the EyeC Proofiler system to ensure conformity between the file and the ready product and check the readability of Braille inscriptions and bar codes and the layout. Each inspection is followed by a report, which takes into account all aspects of the ready product monitoring.
In 2009, we obtained a certificate confirming the application of the Environmental Management System according to ISO 14001. This is an environmental management system modelled on the quality management system according to ISO 9001. The system model is based on the principle of continuous improvement. The ISO 14001 standard contains requirements that can be objectively audited, but does not contain requirements regarding the effects of environmental activities. It is a standard that requires the involvement of all departments at all organisational levels, especially top management. The core of the system is to identify the organisation's environmental aspects as well as the legal and other requirements that apply to these aspects, and to manage them appropriately. The primary objective of the standard is to support environmental protection and pollution prevention in a manner that takes into account the socio-economic needs.
This standard is based on the internationally recognised EN ISO 9001 standard, which defines the requirements for quality management systems. The EN ISO 15378 standard covers the full scope of Good Manufacturing Practices (GMP) used in the production of packaging materials for medicinal products. In particular, it contains additional specific criteria that apply exclusively to packaging materials.
These criteria include:
Monitoring of product batches and their documentation,
- Controlled manufacturing environment conditions,
- Validations and qualifications,
- Risk management.
We were awarded the ISO 9001 Quality Management System Certificate in 2004 and have been continuously improving it ever since. In 2009, we were certified for the Integrated Management System in the following areas:
- Quality Management 9001
- Environmental Management 14001
ISO 9001 is an international standard that specifies the requirements for a quality management system. It can be used by organisations that need to demonstrate their ability to consistently provide products that meet the customer’s and applicable regulatory requirements.
The system provides a standardised approach to manage quality-related activities within an organisation. The Quality Management System consists of the following: organisational structure, planning of processes, resources and documentation, all of which are used by the organisation to achieve the quality objectives and improve its products and services to meet all customer requirements.
