ISO certification

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

principles;

- Plan and program of the internal audits;

- Plan of the corrective and preventative measures

- Analysis of the quality management at the level of upper

management;

- 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.