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Medical project audit
Medical projects and
health care facilities audit

Field specific accreditation and certification
Quality management system (QMS) in the health care facilities forms
an integral part of the modern insurance based, private and state
medicine. Therefore problems of the appropriate legislation follow-up
and preparation of the staff and the establishment for the certification
should be addressed with the great diligence and care.

Introduction of the quality management system with following
accreditation and certification opens up possibilities for identification of
the ineffective stages of the healthcare operations that inevitably leads
to the increase of the efficiency and allows optimization of the
resources avoids duplication of the functions and prevents insufficient
attention to the certain aspects. Quality management system allows for
appropriate documented evidence support and responsibility tracing
along with clear processes decomposition and significantly increase
the quality of the provided services. Introduction of the quality
management system increases the prestige and operational safety of
the medical establishment.

The complex approach to the accreditation and certification includes
preparation of the certain key documents:

- Safety and quality policy for the provided services;
- Quality system plan and program;
- Quality manual and guidelines;
-  Internal procedures in accordance to the quality management
- Plan and program of the internal audits;
- Plan of the corrective and preventative measures
- Analysis of the quality management at the level of upper
- Internal protocols and standard operating procedures development;
- documented support of the engineering and technical operations,
metrology, that support safety and control of the technological
equipment and infrastructure.

Our specialists offer:

- Assistance in the knowledge acquisition and implementation of the
European technical legislation and WTO;
- consulting in the fields of preparation and introduction of the quality
management system for the products and services based on the ISO
9001, environmental management ISO14001, safe working practices
OHSAS 18001, hazard analysis and critical control points system
ISO22000 (НАССР), analytical laboratories accreditation ISO 17025,
clinical laboratories accreditation ISO 15189, quality management
system for the manufacturers of the medical equipment and medical
devices ISO 13485;
- Technical support of the operations on the field specific markets;
- Consulting services for the development and introduction of the
legislative documentation, harmonized with the ЕC, EN and ISO/WTO;
- second opinion audit for the health care establishments, production,
research and development institutions, measurement and calibration
laboratories, regional and municipal governments for the quality and
safety characteristics;
- Consultancy in the field of technical legislation at the preparation
stages for the IPO.
- follow up of the technological audits for the healthcare facilities.
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