Policy Statement on Quality of PHARMOBORONA Test Center, Ltd.

The policy of quality of the PHARMOBORONA Test Center, Ltd., is based on international requirement of GOST ISO/IEC 17025-2009 “General Requirements for Test and Calibration Lab Competence” and GOST ISO 9001-2015 (ISO 9001:2015) “Quality Management System. Requirements”.

The Test Center implements its activity under the Russian law and in accordance with regulations of the Customs Union of Belarus, Kazakhstan and Russia based on the accreditation certificates, licenses and other permit documents.

The Test Center carries out product testing competently, honestly and impartially. This process is fair and equal for all applicants.

Any data collected during the process of service performance or provision are confidential and can’t be disclosed.

In case of interests conflict the Test Center guarantees impartial and independent work performance.

The Test Lab also guarantees security of information received from the customer and impartial complaint and appeal handling.

Based on the quality policy, chief of the Test Lab identifies objectives and tasks in quality control:

The objective of the laboratory is to perform high quality operation and provide high quality services while testing and measuring of products.

Key Tasks for achieving this purpose:

  • achieving and maintaining a high level of organization and providing trials and measurements in accordance with the rules and methods of trials, including  requirement for sampling embodied in the accreditation sphere;
  • providing the customer with objective and reliable information concerning trials (test) and measurement results.

To achieve this objective and fulfill these tasks, the Test Lab ensures:

  • the functioning quality management system meeting the requirements of GOST ISO 9001-2011;
  • to implement its activity under the Russian law and in accordance with regulations of the Customs Union of Belarus, Kazakhstan and Russia;
  • to improve stuff management, monitor proper duty performance, operating in accordance with the Test Lab quality police and staff personal responsibility for the quality of provided services;
  • to organize research (testing) and measurement procedures;
  • to update (actualize) state standards, regulatory documents, research and measurement methods in time;
  • engineering resources (electricity, heating, sewerage system, water supply, telephone and computer networks, mail), technical equipage, including measuring devices, test and secondary equipment;
  • to meet research and measurement (testing) requirements specified in the documents during our activity;
  • to develop our activity taking into account evaluation of performance and quality management system of the Test Lab for its continuous improvement;
  • to guarantee impartiality, confidentiality and independence of the provided procedures;
  • to develop competence of lab staff providing research (testing) and measurement procedures;
  • to carry out internal audits to detect inconsistencies and take corrective and preventive measures.

PHARMOBORONE Test Center, Ltd., is obliged to comply with accreditation criteria and requirements for accredited persons.

All laboratory personnel  providing research (testing) and measurement procedures shall be familiar with the quality manual and be guided by the policy of quality of the test lab’s activity.

 

Test Lab Chief 
PHARMOBORONA Test Center, Ltd.
Stepnova I. V.