(044) 285-83-83
info@umcs.org.ua
Quality management systems certification according to ISO 13485
Certificate of Accreditation №8О018
ДСТУ 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 |
| Application for certification of quality management systems according to ISO 13485, changes | 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.
For supplementary call us on phone numbers or turn to us in any other way, which is convenient for you.
