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KVALITET AD NIS (Quality AD Nis)

Accredited by: ATS

KVALITET AD NIS (Quality AD Nis) is a certification body based in Serbia, accredited under the SRPS EN ISO/IEC 17065:2016 standard. They specialize in certifying compliance for a range of products, including electrical equipment, telecommunications, and medical devices. Established in 2000, they have a notable focus on radio equipment and medical devices, ensuring quality assurance and compliance with relevant regulations.

http://www.kvalitet.co.rs/

Bulevar Svetog cara Konstantina 82-86, 18000 Nis

Certification Scopes (9)

ISO 13485

Product Certification

Accreditation Body of Serbia

Serbia

КВАЛИТЕТ АД НИШ certifies compliance with ISO 13485 for medical devices, ensuring that organizations involved in the design, production, installation, and servicing of medical devices meet quality management system requirements. Their certification covers a wide range of medical products, including in vitro diagnostic devices, surgical instruments, and active medical implants, thereby promoting safety and effectiveness in healthcare.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
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ISO 9001

Management System Certification

Accreditation Body of Serbia

Serbia

КВАЛИТЕТ АД Ниш certifies organizations under ISO 9001, focusing on quality management systems across various sectors. Their certification encompasses a wide range of industries, including healthcare, engineering services, information technology, and public administration, ensuring that organizations meet international quality standards.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
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ISO 45001

Management System Certification

Accreditation Body of Serbia

Serbia

КВАЛИТЕТ АД Ниш certifies organizations under ISO 45001, focusing on occupational health and safety management systems. This certification applies to various sectors, including wholesale and retail trade, vehicle repair, and manufacturing, ensuring that companies implement effective measures to enhance workplace safety and reduce risks to employees.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
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ISO/IEC 17065

Product Certification

Accreditation Body of Serbia

Serbia

КВАЛИТЕТ АД НИШ certifies compliance with the ISO/IEC 17065 standard for various sectors, focusing on electrical products, telecommunications, and medical devices. Their certification scope includes radio equipment, gas appliances, and a wide range of medical devices, ensuring that these products meet safety and quality standards as per relevant regulations.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
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ISO/IEC 27001

Management System Certification

Accreditation Body of Serbia

Serbia

КВАЛИТЕТ АД Ниш certifies organizations under ISO 27001, focusing on the establishment, implementation, maintenance, and continual improvement of an information security management system (ISMS). This certification is applicable across various sectors, including wholesale and retail trade, vehicle repair, and manufacturing, ensuring that organizations effectively manage sensitive information and mitigate security risks.

Repair
maintenance and installation of machinery and equipment
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ISO/IEC 17021-1

Management System Certification

Accreditation Body of Serbia

Serbia

KVALITET AD Niš certifies organizations in various sectors under ISO 17021-1, focusing on management system certifications. Their scope includes certifications for quality management systems, environmental management systems, and specific standards related to medical devices and information security, ensuring compliance with international standards across multiple industries.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
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ISO 14001

Management System Certification

Accreditation Body of Serbia

Serbia

КВАЛИТЕТ АД Ниш certifies organizations under ISO 14001, focusing on environmental management systems. Their certification covers various sectors including wholesale and retail trade, construction, electrical and optical devices, machinery, and engineering services, ensuring that these entities adhere to effective environmental practices.

Architectural and engineering activities; technical testing and analysis
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ISO 13485

Management System Certification

Accreditation Body of Serbia

Serbia

КВАЛИТЕТ АД Ниш certifies organizations under ISO 13485, focusing on quality management systems for medical devices. Their certification encompasses a wide range of sectors, including distribution services for medical devices, in-vitro diagnostic medical devices, and both active and inactive medical equipment, ensuring compliance with international standards for safety and effectiveness.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
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ISO 15189

Product Certification

Accreditation Body of Serbia

Serbia

КВАЛИТЕТ АД НИШ certifies medical laboratories under ISO 15189, ensuring that they meet international standards for quality and competence in medical testing. This certification encompasses various aspects of laboratory operations, including management, technical processes, and the reliability of test results, thereby enhancing the quality of healthcare services.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
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