Technical Regulations of Ukraine emphasize, that it is mandatory to establish functioning a quality management system (QMS) on the manufacturing site. These requirements of national legislation regarding technical regulation are set up for both national and foreign manufacturers. National legislation highlights the concept of ‘European harmonized standards’, voluntary observance of which is a confirmation of conformity of medical devices with the Technical Regulations concerning medical devices. In this list, approved by the Order of the Ministry of Economic Development and Trade of Ukraine No. 663 dated June 24, 2015, it is worthy to identify an industry-specific standard for manufacturers of medical products, DSTU ISO 13485:2005.
QMS is compulsory as for the following safety classes of medical devices:
- Medical device of Class Is (sterile);
- Safety Class Im (measuring);
- Safety Class IIa, IIb and III according to the Technical Regulations concerning Medical Devices (Decree of CMU No. 753);
- Reagents, calibrators and controls, stipulated in the List A and B of the Technical Regulation on Medical Device (Decree of CMU No. 754), devices intended for self-testing;
- All medical devices covered by the Technical Regulation concerning active implantable medical devices (Regulation of CMU No. 755).
DSTU ISO 13485:2005 is based on the European standard ISO 13485:2003, but the latter has a number of inherent minor particularities. QMS shall be developed and implemented on the enterprise. System certification is not an obligation according to the Technical Regulations and shall be performed upon request of the manufacturer.
It is a compulsory requirement for national manufacturers, who are planning to export their products to the EU market, the availability of the implemented system under the international standard ISO 13485 is a compulsory requirement.
Frequently, an enterprise has a quality management system already, and it requires analyzing and adaptation to meet the requirements of DSTU ISO 13485:2005. Conformity assessment bodies “approve” the QMS and “confirm” the possibility to produce, within the system, products of appropriate quality, which meet the requirements of the Technical Regulation. However, it is possible (at the manufacturer’s discretion) to conduct the QMS certification and obtain a conformity certificate on quality management system accompanying with product conformity certificate.
Cratia renders the following services in:
- Diagnosis and analysis of a quality management system established on the enterprise;
- Developing documentation: quality manuals, standard operating procedures (SOP), instructions, procedures, policies, standard techniques, etc.
- Staff training in:
- Fundamentals of quality management. ISO 13485 Standards:
- Internal QMS audit. ISO 19011;
- Directives 93/42/EEC, 98/79/EEC and Technical Regulation of Ukraine;
- Risk Management for medical devices, ISO 14971 Standard;
- Implementation of quality management system;
- Pre-certification audit;
- Support for the enterprise during the audit;
Budget for QMS development and implementation depends on several issues:
- The number of employees involved in medical devices production.
- Availability of regulatory documentation on the enterprise (SOPs, orders on hiring of employees, job descriptions, registers with the evaluation of suppliers, work instructions (safety, electrical safety, fire safety), etc.
- Availability of other QMS in the enterprise (ISO 9001, Good Manufacturing Practice (GMP) and others).
- The list of products, production lines.
- Types of manufacturing operations, running in