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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

 

Notice: New editions of ATS documents

In the previous period, the Accreditation Body of Serbia made changes in the existing documents and published new editions of procedures and guidances, as follows:

  • ATS-PR13_Development, Establishment and Extension of accr. schemes_3-0_23.08.2021
  • ATS-PR16_Resolution and complaints_6-0_23.08.2021
  • ATS-PR18_Accreditation for designation (notification) purposes_1-0_16.08.2021
  • ATS-PR19_Evaluation of CAS_1-0_23.08.2021
  • ATS-UP01_List of documents containing requirements for accreditation_8-0_25.08.2021
  • ATS-UP02_Guidelines for formulating the scope of accreditation of the CAB_1-0_07.09.2021
  • ATS-UP 07_List of testing, calibration, inspection, certification codes, key words_4-0_15.08.2021
  • ATS-UP 21_Code of Assessors_2-0_16.08.2021
  • ATS-UP 23_Code of Experts for Accreditation Decision-making_1-0_16.08.2021
  • ATS-UP 25_ Accreditation of sampling activities_2-0_05.08.2021
  • ATS-UP 26 Guidelines for Accreditation of CBs in the Field of Organic Production__2-0_03.09.2021
  • ATS-UP ATS-UP 38_Determining locations, number of assessment days and necessary witnessing_3-0_16.08-2021 28_Accreditation of flexible scope_3-0_02.09.2021
  • ATS-UP 39_Guidance for assessment of PTP_1-0_07.09.2021
  • ATS-UP 41_Evaluation of CAS_2_0_23.08.2021
  • ATS-UP 42_Guidelines for application of ISOIEC 17020_ILAC P15_1-0_22.07.2020

 

These documents can be found on ATS website: HERE►

Sincerely, Your ATS

Notification: New issues of ATS rules 


In the previous period, the Accreditation Body of Serbia made changes to the existing documents and published new editions of documents, namely:

- ATS-PA02, Rules for participation in proficiency testing programs and inter-laboratory comparisons, 4/0 from 27.07.2021
- ATS-PA03, Rules for obtaining metrological traceability of measurement results, 4/0 from 27.07.2021
- ATS-PA04, Rules for the use of accreditation symbol, reference to accreditation and ATS status as a signatory to the EA MLA, ILAC MRA and IAF MLA, 6/0 from 28.07.2021
- ATS-PA05, Rules of cross-frontier accreditation, 4/1 from 27.07.2021
- ATS-PA07, Rules for the use of the mark (logo) of ATS, 2/0 from 28.07.2021
- ATS-PA08, ATS Scope of activity, 2/0 from 05.08.2021

 

 

These documents can be found on the ATS website: HERE►

 

Sincerely,

Your ATS

 

  • European Accreditation
  • Ilac
  • IAF