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Certifikační orgán Českého metrologického institutu pro certifikaci systémů managementu
Accredited by: CAI
Certifikační orgán Českého metrologického institutu pro certifikaci systémů managementu is a certification body based in the Czech Republic, specializing in the certification of management systems. The organization operates under the auspices of the Czech Metrology Institute, ensuring compliance with national and international standards. It provides services aimed at enhancing the quality and reliability of management practices across various sectors. The body is committed to promoting best practices and continuous improvement in management systems.
Hvožďanská 2053/3, 148 00 Praha - Chodov
Certification Scopes (1)
ISO 13485
Certification Body for Management Systems
Czech Accreditation Institute
Czechia
The certification scope covers the quality management systems (QMS) for the provision of medical devices and related services, as per the standards ISO 13485:2016 and its European equivalent. It includes certification for both inactive medical devices, such as general non-implantable devices and inactive implants, as well as active non-implantable medical devices. Additionally, the scope encompasses sterilization methods for medical devices, specifically ethylene oxide sterilization, and services related to the distribution and maintenance of these devices. The accredited body is the Czech Metrology Institute, located in Prague.
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