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Certification ISO 13485

Quality management systems certification according to ISO 13485

Certificate of Accreditation №8О018

DSTU ISO 13485 sets the requirements to Quality management systems, which can be applied by organization for design and development, manufacturing, installation and operation of medical devices and for design, development and rendering of services related to them.

Implementation of Quality management system according to ДСТУ ISO 13485 is a strategic solution of the organization and is one of confirmation of conformity to Technical regulations for medicine.

SE “UMCC” is a Quality management systems certification body.

Quality management systems certification starts with filing of application.

Document Title Download (language)
Application for Quality system certification according to ISO 13485 Укр Рус Eng
Questionnaire for Quality system certification according to ISO 13485 Укр Рус Eng
Audit process, schemes of certification, certification and supervision of QMS Укр Рус Eng
The process of suspension, reduction, recertification, extension Укр Рус Eng

 

Quality system certification procedure provides consideration, analysis and expert examination of documentation concerning Quality management system and audit in the location area of subject of certification.

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