Work Health and Safety & Our Enviromental Policy
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Employees of Üzümcü A.Ş. producing medical devices and medical gas systems adopted secure working; environment and protection of natural resources as a principle.
We, besides fulfilling the legal conditions of issues relevant to employees’ health, work security and environmental health follow up the legal modifications to be established; and have a great desire to conduct the required arrangements accordingly. Our prior objectives in this framework are as follows.
- To take necessary precautions compatible with risk levels by fixing potential dangerous conditions and environments that our employees may subject to;
- To determine environmental impact dimensions of our studies and production and to take control precautions by preparing an assessment report;
- To minimize work accidents, work related diseases and work looses;
- To prevent noise, emission, water and energy consumption and environmental pollution of waste products originating from our activities by utilizing energy and natural resources more efficient and productive manner and to search for reuse / recycling opportunities,
- Raise awareness of our employees relevant to Work Health and Security and Environmental issues,
- To follow up and to develop continuously the environmental effects of our studies, and performance of work health and security implementation under the framework of explicitly described targets and objectives
We hereby consider Environment, Work Health and Security as an integral part of our institution’s culture; and we hereby undertake to supply required sources and to sustain this policy with determination by providing participation of our employees Because,
"The factor enriching our activities and production is that we do not endanger life securities and environment of our employees."
Quality Management Systems
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ISO 9001:2000 AND ISO 13485:2007 QUALITY MANAGEMENT SYSTEM
ISO (International Organization for Standardization) is a quality management standard established by the international standardization organization. ISO 9001 Certificate proves that products or services of the relevant enterprise are manufactured and provided in accordance with an internationally approved management system and therefore it determines the guarantee that sustainability of enterprise’s product and service quality can be ensured. ISO 13485:2007 standard covers quality management system for an enterprise necessitating to prove ability of supplying of medical devices and customer needs consistently and matching of provisions of legislation applicable to services related to medical devices. Fundamental purpose of this standard is to facilitate stipulations of medical devices legislation (MDD 93/42/EEC) harmonized for quality management systems
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CE CERTIFICATION PROCESS
CE marking indicates that the product complies with the European product legislations. CE marking also indicates that a product or a product group is in conformity with the basic requirements called as “product directives” which were established by the European Union in the fields of health, security, environment and protection of the consumer.
“Medical Devices Decree” no. MDD 93/42/EEC classifies the medical devices according to the risk they bear as follows:
Class No and CE Certification Process
- Class I Manufacturer declares conformity of the relevant product to MDD. This certification is not made by any certification body.
- Class IIa/ Class IIb/ Class III CE certification of the devices under these classes is made solely by the authorized certification body.
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TSE – TURKISH STANDARDS CONFORMITY CERTIFICATE
TSE Certificate is a certificate that is issued to name of the manufacturer proving that the products of that company that is entitled to obtain Certificate of Competency for Manufacturing comply with the concerned Turkish standard where Turkish standards are necessary to comply with; and granting to the manufacturer the right to use TSE mark based on the signed contract
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TSEK – QUALITY CONFORMITY CERTIFICATE
Quality Conformity Certificate is a certificate proving that the products of the companies which are entitled to obtain Certificate of Competency for Manufacturing where Turkish standards are non-existing, comply with the Quality Factor and Values accepted by Turkish Standards Institute on the basis of the relative international standards, similar Turkish standards, national standards of other countries and the technical literature. This Certificate is issued to the name of the company that is entitled to use TSEK brand based on the signed contract and defines the trade mark, kind, class, type and sort of the products on which TSEK mark to be used.