Certyficates
In 2004, we were awarded the Quality Management System in compliance with ISO 9001:2000.
We currently have an Integrated Management System that complies with the following standards:
- ISO 9001 Quality Management Systems,
- ISO 14001 Environmental Management Systems,
- EN ISO 15378 Primary packaging materials for medicinal products – Specific requirements for the application of ISO 9001:2015 with consideration of good manufacturing practice (GMP).
The scope of certification covers the production of packaging materials for the pharmaceutical and cosmetics industries.
ISO 14001
On 16 October, we obtained a certificate confirming the application of the Environmental System in compliance with ISO 14001:2004. The environmental management system according to ISO 14001 is based on the quality management system in compliance with ISO 9001. The system model is based on the principle of continuous improvement. ISO 14001 contains requirements which may be objectively audited; however, it does not contain requirements pertaining to the effects of environmental activity. It is a standard requiring the involvement of all services on all organisational levels, especially the top management. At the core of the system is the identification of environmental aspects of an organisation and legal requirements, and the likes, which apply to these aspects and the proper management of these aspects. The basic task of the standard is to assist the environmental protection and counteract pollution, at the same time taking social and economic needs into account.
ISO 15378:2018
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.
ISO 9001:2015
This international standard sets high-quality management standards. By complying with ISO 9001, we have clearly defined procedures that guarantee high-quality products and services for our customers. We focus on continuously improving our processes, identifying and eliminating potential problems, and ensuring customer satisfaction.
"Technology by Heidelberg" certificate
We have been granted the right to use the "technology by HEIDELBERG" mark, which confirms that we have:
- a top-class machine park based on Heidelberg devices and solutions,
- premium production quality standards and management.