Process of the transition to SRPS ISO 15189:2008
Notices
The Accreditation Board of Serbia will commence assessing medical laboratories in line with SRPS ISO 15189:2008 starting from 15.03.2009, so medical laboratories may choose the standard that will form a basis for the assessment (SRPS ISO 15189:2008 or SRPS ISO/IEC 17025:2006).
Medical laboratories that were accredited as per SRPS ISO/IEC 17025:2006 may express their intention to get accredited as per SRPS ISO 15189:2008 by submitting an application for accreditation with accompanying documents. On the occasion of applying a laboratory will choose whether it also wants to maintain its accreditation as per SRPS ISO/IEC 17025:2006.
When submitting and application for accreditation as per SRPS ISO 15189:2008, an accredited laboratory shall also submit the following documents:
- completed accreditation application form ,
- Quality Manual harmonised with the requirements of SRPS ISO 15189:2008,
- scope of accreditation described in accordance with the Guides for Describing the Scope of Accreditation of Medical Laboratories ,
- list of changed in-house procedures/guides and a concise overview of those changes,
- data on all changes of in-house operation of a laboratory made during the period of operation transition to the requirements of SRPS ISO 15189:2008.
The Accreditation Board of Serbia will, during regular surveillance visits, reassessments or during additional assessments after the submission of the application for accreditation referred to in the previous point, perform conformity assessment of an accredited laboratory as per the requirements of SRPS ISO 15189:2008.
After conformity assessment of an accredited laboratory has been performed as per the requirements of SRPS ISO 15189:2008 and after a relevant decision has been made, an accreditation certificate as per SRPS ISO 15189:2008 will be issued. If a body chooses not to maintain its accreditation as per SRPS ISO/IEC 17025:2006, accreditation shall no longer be valid from the date on which this decision was made. The accreditation validity period as per SRPS ISO/IEC 17025:2006 shall have no effect on the accreditation validity period as per SRPS ISO 15189:2008 (it shall commence on the date on which the decision was made and it shall be valid for four years).
If a laboratory chooses to maintain even the accreditation as per SRPS ISO/IEC 17025:2006, the Accreditation Board of Serbia will carry out regular surveillance visits under both standards at the same time.