Chema-Elektromet Spółdzielnia Pracy offers medicinal products and medical devices.
As a manufacturer of medicinal products, we apply a quality system based on the GMP principles, which have been defined in the Regulation of the Minister of Health on the requirements of Good Manufacturing Practice.
The manufacturer of medicinal products is obliged to ensure that the medicinal products manufactured thereby are suitable for their intended use, meet the requirements of the marketing authorization and do not expose patients to risk related to insufficient safety of use, inadequate quality or too low effectiveness. The GIF certificate is a confirmation of the compliance of the manufacturing conditions with the requirements of Good Manufacturing Practice, ascertained during the inspection.
GMP CHEMA 2024 EN ul. Przemysłowa |
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GMP CHEMA 2024 EN Active substance |
As a manufacturer of medical devices, we apply a quality management system that meets the requirements of ISO 13485 and Directive 93/42/EEC on medical devices (Medical Devices Act). Having this system, we demonstrate the ability to deliver medical devices that meet customer requirements and the requirements of regulations applicable to medical devices.
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M – 111-a/1/2022 |
PL – M – 111-a/2/2024 |
M – 111-b/1/2022 |
PL – M – 111-b/1/2022 |
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1434-MDD-140/2021 |
1434-MDD-214/2021 |
1434-MDD-215/2021 |
1434-MDD-216/2021 |
1434-MDD-216/2021 |
1434-MDD-216/2021 |
M_111_a_2_2024 CHEMA – cert. ang sign |
M_111_a_1_2022 CHEMA – cert. IQNET sign |
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M_111_b_1_2022 CHEMA – cert. IQNET sign |
Quality Policy
Chema-Elektromet Spółdzielnia Pracy is a manufacturer of medicinal products and medical devices.
The strategic goal of Chema-Elektromet Spółdzielnia Pracy is the production and sale of medicinal products and medical devices of the highest quality, meeting legal requirements and satisfying the requirements, needs and expectations of customers.
The implementation of the quality policy is guaranteed by achieving the following goals:
1. Compliance with the Good Manufacturing Practice requirements
- Meeting the requirements of the PN-EN ISO 13485 standard and maintaining the effectiveness of the quality management system
3. Streamlining processes and working conditions
4. Improvement of manufactured and implemented new products
5. Selection of suppliers meeting the specified requirements
6. Improving the professional qualifications of employees and developing their awareness for quality and responsibility for the work performed.
Care for the health of patients and the authority of the organization are the basis of the quality policy.
Rzeszow, 05/03/2019
Management Board
CHEMA-ELEKTROMET
Spółdzielnia Pracy