Testing laboratory evaluation of medicine product quality

DECLARATION of independent

of independent test laboratory JSC «SIVIlab»

  1. Test laboratory (hereafter «IL»)  «SIVIlab» is an independent institution in technical, financial and legal terms on customers or other parties interested in the results of tests performed.
  2. The process of performing and handling test results as well as protocol registration based on results of tests performed is arranged in such a way as to eliminate the possibility of commercial, financial, administrative or any other pressure on staff that can influence on the results of test performed.
  3. Organizational structure of LLC «SIVIlab» provides performance of its functions as test laboratory. Staff of TL consists of competent specialists, holding valid certificate on special training on system functioning and performance of required tests as per approved accreditation area.
  4. Quality management system meeting GOST ISO 9001-2011 was developed and implemented in TL «SIVIlab».
  5. The customer and (or) other parties not taking part in performance and handling test results are given access after duly registration and approval of test protocol. 
  6. A possibility of influence on TL «SIVIlab» employees by customers in order to change test results is eliminated. An employee met with illegal pressure must inform TL management.  
  7. As per «Regulation on test laboratory» operational and general management of TL is performed by CEO or head. Test quality and terms of works performed are controlled by TL head, quality manager appointed by CEO. TL employees comply with internal local organizational-administrative docu-ments of enterprise regulating issues of labor discipline, directions and instructions of management personnel related to economic and industrial activity of the enterprise.
  8. In the TL there are regulatory documents required for performance of tests in scope specified in the accreditation area, their consecutive handling and execution of test protocols including relative con-clusions on the results of works performed.
  9. TL acknowledges all the rules and requirements specified in GOST ISO/IEC 17025-2009 «General requirements for the competence of testing and calibration laboratories» and «Criteria for accredita-tion of certification authorities and test laboratories (centers) and requirements to them», approved by the order No 682 of Ministry of economic development and trade of the Russian Federation dt. 16.10.2012.