Popularization of the sphere of accredited certification of the quality management system of medical devices by interviewing

The subordinate organization of the KTRM MTI RK - the National Accreditation Center within the framework of studying and promoting the accreditation scheme of bodies for confirming the conformity of management systems of medical devices in the Republic of Kazakhstan, conducts a study of the scope of bodies for certification of management systems according to ISO 13485 "Medical devices. Quality management systems. Requirements for regulatory purposes". The interstate standard GOST ISO 13485-2017 "Medical products" is applied on the territory of the Republic of Kazakhstan. Quality management systems. Requirements for regulatory purposes".

The ISO 13485 standard is considered to be a rather narrow, specific, industry standard that establishes requirements for a quality management system for organizations engaged in and related to medical devices (medical devices, medical equipment, medical devices for in vitro diagnostics) in general, starting from the design of production and ending with installation and maintenance. Suppliers of parts and assemblies for manufacturers of medical equipment, manufacturers of various synthetic and organic materials for medical purposes also fall under the scope of this standard. Software developers must also comply with the requirements of the standard. The terminology of medical devices, according to the standard, means the following. A medical device is an instrument, apparatus, device, device, equipment, implant, in vitro reagent, software, material or other similar or related products intended by the manufacturer for use to a person individually or in combination: – diagnosis, prevention, monitoring, treatment or relief of diseases; - diagnosis, monitoring, treatment, relief or compensation of the consequences of injury; - studies, substitutions or changes in the anatomical structure or physiological processes; - life support or maintenance of vital functions; - conception management; - disinfection of medical devices; - obtaining information through in vitro examination of samples taken from the human body, as well as those that do not achieve their primary intended effect on the human body due to pharmacological, immunological or metabolic means, but whose functions can be supported by such means. It should be borne in mind that some products individually can be classified as medical, but a unified approach has not yet been developed in relation to them.

Such products can be:

- disinfectants;

- aids for persons with disabilities; - products including animal or human tissues;

- products for in vitro fertilization and reproductive technologies. The ISO 13485 standard is not applicable for pharmaceutical activities, for medical institutions and laboratories. GMP rules are provided for pharmaceutical activities, which is a collection of good manufacturing practice standards.

For medical and preventive institutions, there is an international working agreement of recommendations for improving processes in healthcare organizations based on the ISO 9001 standard.

For laboratories, there is a whole set of norms and rules based on the implementation of the principles of good laboratory practice (GLP), a system of norms, rules and guidelines aimed at ensuring consistency and reliability of laboratory results. Medical devices are different from other consumer goods and products. They play an important role in the provision of medical care, being an integral part of it. The quality, safety and effectiveness of medical devices play a key role. The main purpose of the introduction of regulatory systems for medical devices is to protect public health and ensure their safety and functional characteristics. The main criterion for the quality of manufactured medical products is the ISO 13485 certificate. This certificate is required by the manufacturer of medical devices, developers of software for medical equipment, during the maintenance of medical equipment, organizations that are involved in the life cycle of medical devices, suppliers for the production of medical devices. The requirements for maintaining documentation are prescribed in the standard.

One of the fundamental documents in the production of medical devices is a technical file (medical device file), in addition to procedures regulating the requirements for the creation, maintenance and monitoring of the production environment, personnel working in it, products with special handling conditions, especially if these products are sterile, measures to control contaminated or potentially contaminated products, records, confirming all stages and actions, external and internal factors affecting the fulfillment of these requirements; risk management requirements for all product lifecycle processes; traceability records; risk management documents, etc.