Accreditation body of Serbia

28.06.2021. Accreditation Day in the Republic of Serbia

Pursuant to the Statute of the Accreditation Body of Serbia, ATS established 9th June as the World Accreditation Day and 28th June as the Accreditation Day in the Republic of Serbia when the first accreditation was granted in Serbia in 2000.

Accreditation Body of Serbia

The Accreditation Body of Serbia (ATS) is the national accreditation body of the Republic of Serbia established by the Republic of Serbia by means of the Act on Establishment of the Accreditation Body of Serbia - integral version (“Official Gazette of the RS”, No. 96/2006; no. 14/2011 and 79/2021) to perform the activities referred to in Articles 3 and 8 of the Law on Accreditation (“Official Gazette of the RS”, No. 73/2010;47/2021).

New edition of the Application for Assessors and Technical Experts

03 Nov 09:39Notices Current events Document Amendments

Notice: New edition of the Application for Assessors and Technical Experts

The Accreditation Body of Serbia is publishing a new edition of the Application for Assessors and Technical Experts.

The beginning of the application of the new edition of the form is from 01.11.2021

Candidates for assessors and technical experts can apply by submitting a completed Application for assessors and technical experts and submitting them in electronic form to the address: atsocenjivaci@ats.rs, together with the documentation listed in Part B of the Application for assessors and technical experts "Mandatory documentation required should be submitted with the application’’.
" The specified form ATS-PR02-O01, you can download on the ATS website: HERE►

Sincerely,

Your ATS

New issue of Application for accreditation and Accreditation Contract

29 Oct 11:18Notices Current events Document Amendments

Notification: New issue of Application for accreditation and Accreditation Contract

The Accreditation Body of Serbia publishes new issues of the forms, as follows: Application for accreditation, sixth edition and Accreditation Contract, fourth edition.
The beginning of the application of these new editions of the forms is from 01.11.2021.

The amendment of the Accreditation Application and the Accreditation Contract is a consequence of the harmonization with the new, thirteenth edition of the Rules of Accreditation, the beginning of the application of which is also from November 1, 2021, as well as with the Law on Accreditation ("Official Gazette of RS" No. 73/2010 and 47/2021).

The listed forms ATS-PR11-O01 and ATS-PR11-O07, can be downloaded from ATS website: HERE►

Sincerely, Your ATS

Extension of the scope of activity of ATS to the accreditation of the body for conformity assessment of medical devices

20 Oct 14:05Notices Current events Document Amendments

Notification: Extension of the scope of activity of ATS to the accreditation of the body for conformity assessment of medical devices in the field covered by the Law on Medical Devices ("Official Gazette of RS", No. 105/17)

In accordance with the Rules of Accreditation and its procedures, ATS has expanded the scope of its activity to the accreditation of CABs in the field of medical devices, in accordance with the regulations adopted based on the Law on Medical Devices. The procedure of accreditation of CABs shall be carried out for the purpose of their designation (notification) or authorization in accordance with the Law on Medical Devices ("Official Gazette of RS", No. 105/17) and the Rulebook on Basic Requirements for Medical Devices ("Official Gazette of RS", No. 65/18) and the Rulebook on suspension and withdrawal, as well as on the Rulebook on technical assessment of a medical device on the market ("Official Gazette of RS", No. 99/2018, 37/2019).

For the needs of accreditation in this field of conformity assessment, the Guidance ATS-UP44 Accreditation Criteria and Guidelines for assessment of bodies for conformity assessment of medical devices, issue/revision 1/0 from 07.09.2021, has been prepared, and is also available on the ATS website. By publishing the above guidance, ATS is ready to accept and apply for accreditation/extension of the scope of accreditation for conformity assessment in accordance with the regulations adopted based on the Law on Medical Devices.

New document ATS-UP44 Accreditation Criteria and Guidelines for assessment of bodies for conformity assessment of medical devices, issue/revision 1/0 from 07.09.2021, can be found on the ATS website: HERE►

Sincerely,
Your ATS