ERBI Group

Certyficates

Our certifying body is TÜV NORD POLSKA Sp. z o.o.
In 2004, we were awarded the Quality Management System in compliance with ISO 9001:2000.
In 2009, we obtained a certificate for the Integrated Management System as regards:
  • Quality Management 9001:2008
  • Environmental Management 14001:2004
  • PN-EN ISO 15378:2012 for external solid board packaging, paper leaflets and labels for the pharmaceutical industry, taking Good Manufacturing Practices (GMP) into account.

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.

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ISO 15378:2012

Materials for immediate packaging of medicinal products. Particular requirements related to the application of ISO 9001:2000 with the consideration of Good Manufacturing Practices (GMP). ISO 15378 was developed by the Technical Committee ISO/TC 76.
Equipment for transfusion, infusion and injection for medical and pharmaceutical uses. Its purpose is to determine uniform requirements pertaining to packages in contact with medicinal products. The standard defines the packaging in contact with the product as "packages used in packing pharmaceutical products which are to serve for storing, sealing or administering doses and which are intended for direct contact with the medicinal product." Such packages may be made of glass, rubber, plastic, aluminium, coating or foil; they may as well be a combination of different materials or components, such as in the case of syringes or aerosol valves.

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ISO 9001:2008

Since 2004, we have been improving our Quality Management System Certificate in compliance with ISO 9001:2000. In 2009, we obtained a certificate for the Integrated Management System as regards:

  • Quality Management 9001:2008
  • Environmental Management 14001:2004
  • Safety Management and OSH PN-N 18001:2004
ISO 9001:2008 is an international standard which contains requirements pertaining to quality management systems. It is applicable when organisations need to indicate that they are capable of continuous provision of a product which meets customer requirements and other requirements in terms of overriding provisions.

The system is a standardised method for an organisation to govern and control its business activities related to quality. The Quality Management System consists of: organisational structure, planning of processes, resources and documentation used by the organisation to achieve quality-related targets and improve its products and services by meeting its customers halfway.

The system is intended for enterprises of different sizes as it applies to how the company is supposed to be managed; it presents tools for different aspects.

At present, there is no management system which would be more universal or standardised than the one presented in ISO 9001:2008. This system can apply to any organisation. It is gaining in popularity in all types of service-providing organisations, for instance in municipal management, housing, hospitals and outpatient clinics, funeral homes and detention centres. ISO 9001:2008 system is also implemented by self-government institutions or administrative organs, for instance county offices and councils in towns, gminas or villages. Frequently, customers "require" from their subcontractors that they possess the quality certificate in compliance with ISO 9001:2008, which guarantees the maintenance of a quality system in the company.

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