QUALITY ASSURANCE AND ACCREDITATION OFFICE (DJ)
Personnel:
Head: Joanna Gwiazda, Ph.D., phone: 022 851 52 36, 022 841 36 89 ext.439,
Secretary: Agnieszka Pękala, phone/fax: 022 851 43 70,
Elżbieta Albińska M.Sc. phone: 022 851 43 70, 022 841 36 89 ext. 442
Maria Deka M.Sc. phone: 022 851 43 70, 022 841 36 89 ext. 442
Joanna Tyska M.Sc. phone: 022 851 43 70, 022 841 36 89 ext. 442
Marek Barski engineer phone: 022 851 43 70, 022 841 36 89 ext. 442
Activity:
- introducing of quality system in accordance with standard PN-EN ISO/IEC 17025.
- quality system management concerning routine drug quality control and scientific activity.
The standard describes general requirements for the competence of testing and calibration laboratories. Complying with these requirements confirmed by the accreditation certificate proves that laboratory is:
- complying as well with the requirements of ISO 9001 standard;
- technically competent;
- able to obtain reliable and useful results.
Introducing quality system in the Institute, Director acts through:
Quality Manager, who is Director, s Plenipotentiary and has to ensure, that quality system has been elaborated, introduced, employed and is being constantly improved;
Technical Manager, who is responsible for the implementation of quality system concerning technical activity of the Institute.
Institute is going to be accredited by Polish Accreditation Center (PCA) - which was created by the Act of Polish Parliament on April 28th 2000. This accrediting unit is a member of IAF,TLAC, EA and laboratory reports from the units accredited by PCA are being recognized in Europe and all over the world.
As a result of the implementation of the quality system in the Institute, documents concerning 2 departments of the Institute (MA and RM) were submitted and accepted by Polish Accreditation Center (PCA) and those two departments have already been audited by the PCA auditors. Recommended corrective actions are being implemented at the moment.
Institute was also audited by representatives of OMCL according to scheme set by OMCL Network.
International OMCL Meeting in Warsaw in 2003 was organized by Quality Assurance and Accreditation Unit.
Requirements for the computer program monitoring all the measuring equipment in the Institute were elaborated in the Institute. Computer program "Measurement and control equipment record" was elaborated and installed in the Internet.
Cooperation
internal with all the departments and laboratories
of the Institute concerns:
- general training of the personnel concerning quality system;
- elaboration of the documents,
- controlling of the selected pieces of equipment,
- conducting the training introducing the general documents of the system,
- conducting the internal audits.
external
- European Directorate for the Quality of Medicines (EDQM) in Strasbourg,
- European Network of Official Medicines Control Laboratories (OMCL) standardizing requirements concerning national laboratories of drug control in the countries belonging to EU,
- Polish Accreditation Center (PCA).
