GOST ISO 13485-2017 «Medical devices. Quality management systems. Requirements for regulatory purposes» became the most demanded document in November 2021 according to the information received from the Department of Distribution of the Documents on Standardization of FSBI «RST». This document came into force in 2018.
Medical devices are the following according to current standard- instrument, apparatus, tool, device, equipment, implant, in vitro reagent, software, material or other similar or related to them devices.
Main aim of this document is setting the requirements to the quality management system which can be applied by the organization participating in one or several stages of a life cycle of a medical device including design and development, manufacturing, storage and supply, installation, technical services, final putting out of service, recycling of medical devices or provision of related services.
Main obligations of organizations are the following- identification of processes needed for the quality management system, their application in the organization taking into account the roles accepted, use of risk-oriented approaches to the management of relevant processes, identification of sequence and interaction of these processes.
GOST R 58876-2020 «Quality management systems of organizations of aviation, space and defence industries. Requirements» attracted interest among the customers.
This document has been effective during one year. It was developed for the purposes of improving the results of activities of the companies and provision of fundamental basis for the initiatives oriented at the sustainable development.
Possible advantages of application of such system are the following: potential to provide goods and services on a regular basis which satisfy the demands of the customers and relevant legislative, normative and legal documents, creation of the opportunities for improving satisfaction of the consumers, direction of efforts on risks and opportunities connected with the environment and objectives of an organization and opportunity to demonstrate conformity to the requirements imposed by the quality management system.
This standard uses process approach that includes the following cycle - «Plan-Do-Check-Act» and risk-based thinking.
Process approach enables organization to plan its processes and their interaction. Risk-based thinking helps to specify factors that can lead to some deviations from the planned outcomes of processes and quality management system of the organization. This risk-based approach also promotes to use preventive management tools for the purposes of minimization of negative consequences and maximization of use of emerging opportunities.
One more highly demanded document in November is GOST R 59424-2021 «Guidelines for remote production condition analysis and management systems auditing». It has become effective since September 2021.
Main aim of this document is procedure of carrying out of analysis of manufacturing status and audit of management systems on a remote basis using information and communications technologies for the purposes of improving the efficiency, reducing expenses and minimization of risks in the field of occupational safety.
Such document is vitally needed nowadays due to rapid digitalization of economy that is creating opportunities for conducting audits of management systems and the necessity to resist different global challenges like epidemics, political and economic instability and related restrictions.