Quality and Certification

In order to ensure continuous improvement in the quality and competitiveness of the services provided, the Cratia Group has developed, implemented and maintains a quality management system. Our quality management system applies to all areas of the group of companies, is certified in certain areas according to ISO 9001:2015, and a large number of external audits of our Customers are conducted annually.

ISO 9001:2015 certificates:  

SO 9001:2015 certificate of Cratia
Medtechnika:
service of Authorized
Representative for manufacturers of medical
devices. Consulting in the field of technical
regulation. Translation of medical documentation. 

ISO 9001:2015 Certificate of Cratia Ltd.: consulting services
on: registration, renewal of registration and variations to the
registration materials for medicines; GMP certificate recognition,
GMP compliance audit; establishment and maintenance of
pharmacovigilance system; registration and certification of
cosmetics and food products; translation of documentation;
design and development of graphic materials. 

Extra: 

In 2014-2015, a nonprofit international organization TRACE International (https://www.traceinternational.org/) monitored Cratia according to the internal requirements of one of the Customers prior to cooperation. As a result, a positive conclusion was received.

In 2015, one of the key customers was initiated and conducted an audit of the company under the PSCI program (Pharmaceutical Supply Chain Initiative, https://pscinitiative.org/). As a result, a positive conclusion was received.

Every year we undergo a large number of audits and trainings from our partners.

 

Our quality policy (excerpt): 

  • to maintain the image of a reliable partner and enjoy respect among clients;
  • to raise the level of customer service culture;
  • to provide feedback to the client in order to determine and analyze the degree of compliance of services with customer requirements, as well as improve customer satisfaction in the future;
  • to continuously improve the level of services provided in order to increase competitive advantages and, as a result, increase market share;
  • to ensure a systematic increase in the level of competence of personnel in order to provide services at a high level;
  • to provide working conditions for each employee in order to increase his or her professionalism;
  • to create motivation for each employee to provide services of high quality by means of worthy reward for the effective and qualitative performance of his/her duties;
  • to provide necessary resources to all major business processes for the effective functioning of the management system;
  • to assess possible potential risks in the performance of activities and develop a set of measures to reduce their impact;
  • to carry out a systematic analysis of the functioning of the Quality Management System in order to continuously manage, improve and increase the efficiency of processes;
  • to use the results of internal audits to implement necessary corrective and preventive actions;
  • to optimize costs in order to increase the efficiency of business processes and obtain a guaranteed profit;
  • to maintain mutually beneficial relationships with suppliers and contractors;
  • to take into account external and internal factors affecting the ability of the quality management system to achieve the desired results and develop a set of measures to reduce their impact.

The top management of the organization assumes responsibility for implementation of the quality policy, provision of the organization with resources, continuous maintenance and development of the quality management system.

The Company’s policy is aimed at customer satisfaction and provides a basis for setting goals and analysis in the field of quality.

Implementation of the Quality Policy is monitored during internal audits. The policy is reviewed once a year as part of the analysis of the quality management system by senior management.

 

Cratia professionally performs registration, safety and quality management of medical products in Armenia, Azerbaijan, Belarus, Georgia, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Tajikistan, Turkmenistan, Ukraine, Uzbekistan and the Eurasian Economic Union. We have an excellent knowledge of national legislation, necessary experience and resources.

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