The international standard ISO 13485:2016 ("Medical devices - Quality management systems - Requirements for regulatory purposes") regulates the establishment and implementation of quality management systems at enterprises engaged in the production of medical devices, machinery and equipment. It is the basis for the certification of quality management systems in companies that manufacture or distribute medical devices - or that are involved in their production as part of the supply chain.
In Ukraine, DSTU ISO 13485:2018 is a mandatory requirement for the implementation of medical devices by market operators at any stage: from full-cycle production to one link in the supply chain. DSTU ISO 13485:2018 applies exclusively to the territory of Ukraine. Certification according to DSTU ISO 13485:2018 (as opposed to passing the ISO 13485:2016 certification procedure) is a prerequisite for Ukrainian medical device manufacturers, and vice versa, for those who want to work with Ukrainian honey.
The DSTU standard is a version of the International Standard adapted in accordance with the current Ukrainian legislation and contains the requirements of the national Technical Regulations on medical devices.
Definition of production processes, their order and mechanisms of interaction and control
Determination of applicable clauses of the Standard and development of relevant documentation (SOPs, work instructions, technical documentation for medical devices, etc.)
Staff training on the procedures and requirements of the Standard
Conducting an internal audit of the company and training of internal auditors
Submitting an application for certification by an independent body
the need to implement a management system in accordance with the requirements of the selected standard;
a positive audit of the organisation by an independent certification body and obtaining a certificate;
passing regular supervisory audits by the Certification Body.
