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National Center for Quality Assessment and Technology in Health S.A. (EKAPTY S.A.)

Accredited by: ESYD

The National Center for Quality Assessment and Technology in Health S.A. (EKAPTY S.A.) is a Greek certification body that specializes in the assessment and certification of quality management systems in the healthcare sector. It is accredited under various standards, including ISO 9001 and ISO 13485, focusing on quality management systems for medical devices. EKAPTY S.A. operates primarily in Greece and is recognized for its expertise in healthcare technology assessment.

https://www.ekapty.gr

Mavromateon 15, Athens, TK10434

Certification Scopes (6)

ISO/IEC 17021-1

Management System Certification

Hellenic Accreditation System

Greece

Under ISO 17021-1, the National Center for Quality Assessment and Technology in Health (EKAPTY A.E.) certifies quality management systems specifically for medical devices in accordance with ISO 13485. This certification ensures that organizations involved in the design, production, and servicing of medical devices meet international quality standards.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
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ISO 9001

Management System Certification

Hellenic Accreditation System

Greece

The National Center for Quality Assessment and Technology in Health (EKAPTY A.E.) certifies quality management systems in the healthcare sector under ISO 9001. This certification ensures that healthcare organizations meet consistent quality standards in their services and processes, enhancing patient safety and satisfaction.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
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ISO 13485

Management System Certification

Hellenic Accreditation System

Greece

The National Center for Quality Assessment and Technology in Health S.A. (EKAPTY S.A.) certifies quality management systems for medical devices in accordance with ISO 13485. This certification ensures that organizations involved in the design, production, and distribution of medical devices meet international standards for quality and safety.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
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ISO 14001

Management System Certification

Hellenic Accreditation System

Greece

The National Center for Quality Assessment and Technology in Health (EKAPTY A.E.) certifies environmental management systems under ISO 14001. This certification focuses on organizations in the healthcare sector, ensuring they implement effective environmental practices and comply with relevant regulations.

Human health activities
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ISO 37001

Management System Certification

Hellenic Accreditation System

Greece

The National Center for Quality Assessment and Technology in Health S.A. (EKAPTY S.A.) certifies organizations under ISO 37001, which focuses on anti-bribery management systems. This certification is applicable across various sectors, ensuring that organizations implement effective measures to prevent bribery and promote ethical practices in their operations.

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

Management System Certification

Hellenic Accreditation System

Greece

The National Center for Quality Assessment and Technology in Health (EKAPTY A.E.) certifies products and services in accordance with ISO/IEC 17065, focusing on the evaluation of conformity for medical devices and health technologies. This certification ensures that the products meet the necessary regulatory requirements and quality standards as outlined by EU directives.

Manufacture of basic pharmaceutical products and pharmaceutical preparations
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