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Extension of the scope of ATS to the accreditation of medical laobratories against SRPS EN ISO 15189 and SRPS EN ISO 22870 (Point-of-care testing - POCT)

NoticesCurrent eventsDocument AmendmentsLaws and regulations

In accordance with the Rules of Accreditation and its procedures, ATS has expanded the scope of its activity to the accreditation of medical laboratories against SRPS EN ISO 15189 and SRPS EN ISO 22870 (point-of-care testing -POCT).


For the purposes of accreditation in this field of conformity assessment, the Guidance UP 51 Guidance for the assessment of laboratories against SRPS EN ISO 15189 and SRPS EN ISO 22870 point-of-care testing (POCT).

For the needs of accreditation of medical laboratories for point-of-care testing (POCT), the development, amendment of the accomopanying forms was performed, namely:

  - Application for accreditation in which the Annex D.3.2 for accreditation of POCT is defined (SRPS EN ISO 22870)
  - Check list for the assessment of medical laboratories against requirements of standard SRPS EN ISO 22870:2017 (appendix to           the Check list for the assessment of medical laboratories against SRPS EN ISO 15189:2014)

Also, the new edition of ATS-UP02 Guides for Formulating the Scope of Accreditation of the CAB, Annex 3 defines presentation of the Scope of accreditation of medical laboratories that perform point-of-care testing (POCT) against SRPS EN ISO 15189 and SRPS EN ISO 22780.

All these documents are available on the ATS website.

By publishing these documents, ATS is ready to accept and apply for accreditation/extension of the scope of accreditation of medical laboratories according to SRPS EN ISO 15189 and SRPS EN ISO 22870 point-of-care testing (POCT).

 

Sincerely,
Yours ATS


 

New edition of the Application for Assessors and Technical Experts

NoticesCurrent eventsDocument 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 

NoticesCurrent eventsDocument 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

NoticesCurrent eventsDocument 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

New editions of ATS documents

NoticesCurrent eventsDocument Amendments

 

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

New issues of ATS rules

NoticesCurrent eventsDocument Amendments

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

 

New issue of Rules of Accreditation ATS-PA01

NoticesCurrent eventsDocument Amendments

Note: New issue of Rules of Accreditation ATS-PA01

The Accreditation Body of Serbia publishes a new, thirteenth edition, Rules of Accreditation ATS-PA01.

Amendment of the Rules of Accreditation is a consequence of the harmonization with the Law on accreditation (‘’Official Gazette of the RS“ No. 73/2010  and 47/2021).

A transitional period for the application of the new Rules of Accreditation was determined, so that these Rules enter into force and shall be applied from November 1, 2021. Until then, the Rules of Accreditation ATS-PA01, edition twelfth from 12 of July 2019 shall be applied.

The abovementioned Rules of Accreditation  ATS-PA01, thirteenth edition, August 2021, can be found on the ATS website: HERE

Sincerely, Your ATS

New editions of ATS documents

NoticesDocument Amendments

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 documents, as follows:


-New edition of Rules ATS-PA06, Rules on Estimate of the uncertainty assessment of Measurement; Rules ATS-PA,6 are in accordance with the mandatory document ILAC P14: 09/2020 ILAC Policy for Measurement Uncertainty in Calibration.


-New edition of the Guide ATS-UP36, General Principles of Impartiality; The document is in accordance with documents EA-2/20 G:2020 Consultancy, and the Independence of Conformity Assessment Bodies, ILAC-P15: 05/2020 Application of ISO/IEC 17020:2012 for the Accreditation of Inspection Bodies and EA-2/17 M:2020 EA Document on Accreditation for Notification Purposes.


Sincerely, Your ATS

Celebration on the occasion of the Accreditation Day in the Republic of Serbia 2021

NoticesCurrent eventsAccreditation DayPromotion

On June 28, 2021, the Accreditation Body of Serbia (ATS) organized a celebration on the occasion of the Accreditation Day in the Republic of Serbia, when the first certificate of accreditation was issued 21 years ago.


This was also an opportunity to mark and celebrate WAD, which is globally celebrated on June 9, a date jointly established by ILAC (International Organization for Laboratory Accreditation) and IAF (International Accreditation Forum).

For more information, please vizit: HERE

Yours sincerely, ATS

Congratulations on June 9 – the World Accreditation Day

NoticesCurrent eventsInternational activitiesAccreditation Day

On this occasion, the Accreditation Body of Sebia congratulates World Accreditation Day on June 9, 2021 celebrated globally, to all assessors and technical experts, members of ATS bodies and authorities, esteemed representatives of the Government of the Republic of Serbia, representatives of ministries and professional associations, thhe ATS employees and accredited conformity assessment bodies,  and representatives of all institutions that cooperate with us.

For more information, please vizit: HERE

Sincerely, Your ATS

Law on Contruction Products (Official Gazette of the RS, no. 83/2018)

NoticesCurrent eventsDocument AmendmentsLaws and regulations

Extension of the scope of ATS’s work to accreditation of certification bodies for certification of products, processes and services in the area covered by the Law on Contruction Products (Official Gazette of the RS, no. 83/2018) 


Law on Contruction Products (Official Gazette of the RS no. 83/2018 from October 29, 2018) recognized the role of accreditation in the procedure of notification of  a body for assessment and verification of continuity of performance, which is defined in Article 41 of the Law. It is prescribed that a body which has an accreditation certificate, meets the prescribed requirements for notification given in the law to the extent that the requirements are covered by the scope of accreditation, taking into account the procedures for assessing and verifying continuity of performance for construction products are covered by accreditation.


For more information , please vizit: HERE


Sincerely, Your ATS

 

World accreditation day #WAD2021

NoticesCurrent eventsInternational activitiesPromotion

World accreditation day #WAD2021


International Accreditation Organizations– International Accreditation Forum (IAF)  and International Laboratory Accreditation Cooperation (ILAC),  as every year on June 9, 2021, mark World Accreditation Day globally to better inform the public about the importance and value of accreditation.

This year’s theme of the World Accreditation Day for 2021 is: Supporting the Implementation of the SDGs.

For more information on sustainable development goals, joint statement (IAF presiding and ILAC presiding) and short promotional videos, please vizit: HERE

Sincerely, Your ATS

Law on Amendments to the Law on Accreditation

NoticesCurrent eventsLaws and regulations

Adopted Law on Amendments to the Law on Accreditation 

Assembly of the Republic of Serbia passed the Law on Amendments to the Law on Accreditation, published in the Official Gazette of the Republic of Serbia, no. 47/2021, which entered into force on 18th May 2021. 

You can see the most important changes and amendments to the law: HERE

The Law on Amendments to the Law on Accreditation prescribes deadlines for harmonization of The Act of Establishment, the Statute and the Rules of Accreditation, and also prescribes a deadline for the adoption of Rulebook on the work of the Appeal Committee. 

Sincerely, Your ATS

The expression of interest in vaccination against COVID-19

NoticesCurrent events

The expression of interest in vaccination against COVID-19

The citizens of Serbia can express their interest in vaccination against Covid-19 by filling out a simple questionnaire that can be found on the Portal https://euprava.gov.rs. This is the first step in the organization of mass vaccination and obtaining the date and place of immunization in accordance with the priorities prescribed by the Institute of Public Health of Serbia ”Dr Milan Jovanovic Batut.”

For more information please visit: HERE►

Yours sincerely, ATS

The ATS current account change

NoticesCurrent events

THE ATS CURRENT ACCOUNT CHANGE

We would like to inform all our clients that as of January 4, 2021, the current account of the Accreditation Body of Serbia has been changed.

The new current account is:
Recipient: the Ministry of Economy - the Accreditation Body of Serbia
Account: 840-31306845-37
Model: 97, Reference number: 20-64030040174231700
payment code: 253

NOTE: Indicate the invoice number when stating a payment purpose.

If you need additional information, you can contact Mr. Jovan Simić at 011 3130 375 or via e-mail: jovan.simic@ats.rs, or Mr. Radomir Lekić via e-mail: radomir.lekic@ats.rs, and at the same phone number.

Sincerely, Your ATS

The new issue of the ATS Bulletin

NoticesCurrent eventsPromotion

The new issue of the ATS Bulletin

Dear readers, despite the unfortunate coronavirus-induced situation disrupting us all, our lives, and business activities, we have been trying to keep up the good work. The latest, 24th edition of the ATS Bulletin is the proof of it. We wrote about various topics covering a wide array of quality infrastructure fields as you have already been accustomed to and we hope that we have not betrayed your trust.

This ATS Bulletin main topic is the publication of a new document entitled EA-2/20 G: 2020 Consultancy, and the Independence of Conformity Assessment Bodies defining the EA approach in assessing the independence of conformity assessment bodies concerning conformity assessment activities carried out by these CABs as notified bodies regarding consultancy and other activities outside the scope of accreditation.

Yours sincerely, ATS

Webinar:"How to become a notified body for construction products?"

NoticesSeminarsCurrent eventsLaws and regulations

A webinar entitled: "How to become a notified body for construction products?"

The webinar on "How to become a notified body for construction products?" organized by the Institute for Standardization of Serbia was held on December 7, 2020. The Accreditation Body of Serbia (ATS) also participated as a lecturer.

For more information please visit: HERE►
Sincerely, your ATS

EA General Assembly held

NoticesCurrent eventsInternational activities

EA General Assembly held

Due to the COVID-19 pandemic, General Assembly  (GA) of the European co-operation for Accreditation (EA), which lasted from 25-26 November 2020, took place entirely online.The General Assembly brought together over 80 participants from 50 national accreditation bodies (NABs), the European Commission, EC, recognized stakeholders and EA Advisory Board, with the participation of their chairpersons.

At the meetings that were held in these two days, Aco Janjićević, PhD, the ATS Acting Director. In the continuation of the news, we single out some of the most important decisions that were made. HERE

Sincerely, Your ATS

RESOLUTIONS ADOPTED AT THE 24TH GENERAL ASSEMBLY OF ILAC AND RESOLUTIONS AT THE 34TH GENERAL ASSEMBLY OF THE IAF

NoticesCurrent eventsInternational activities

RESOLUTIONS ADOPTED AT THE 24TH GENERAL ASSEMBLY OF ILAC AND RESOLUTIONS AT THE 34TH GENERAL ASSEMBLY OF THE IAF

Given the current difficult situation caused by the coronavirus pandemic, online meetings of the 24th General Assembly of ILAC were held on October 22, 2020 and the 34th General Assembly of IAF, November 5, 2020.

Below, we highlight some of the Resolutions adopted HERE

Sincerely, Your ATS

Work from home continues due to the aggravated epidemiological situation

NoticesCurrent events

Work from home continues due to the aggravated epidemiological situation

The Accreditation Body of Serbia (ATS) informs all the clients and external associates the decision the ATS employees work from home during the aggravated epidemiological situation caused by coronavirus (SARS-COV-2) is still in force. Hence the continuity of ATS business activities is ensured.

ATS continues the implementation of all planned assessments by choosing those assessment techniques enabling confidence in competence, regularly reviewing all the relevant information received from conformity assessment bodies and their assessors and experts related to the epidemiological situation, while taking care to protect the health and safety of each assessment participant to the highest possible extent.

Depending on the further development of the situation, additional conformity of assessment plans will be implemented for certain conformity assessment bodies. We kindly ask you for your understanding. Competent Accreditation File Managers will inform you regularly.

For further information on how to communicate with ATS please refer to the following link :HERE►

Best regards, ATS

The NAH and ATS bilateral meetings

NoticesCooperationInternational activities

The NAH and ATS bilateral meetings

In the period from November 23 to 27, 2020, ATS is a host to a dear guest from the region, Mr. Miklós Devecz,  the NAH (National Accreditation Body of Hungary) Director and on that occasion bilateral meetings of the two accreditation bodies, NAH and ATS were held. The most important activity of the first two days of the meetings is the harmonization and signing of the Action Plan for 2021 for the implementation of the Memorandum of Understanding between NAH and ATS, signed in December 2017.


prof. Aco Janićijević, PhD, the ATS Acting Director and Mr. Miklós Devecz, the NAH Director after signing the Action Plan

For more information please visit: HERE►

Sincerely, your ATS

The ATS activities from November 16 to 27, 2020

NoticesCurrent events

The ATS activities from November 16 to 27, 2020

Pursuant the Decision of the Director of ATS no. 1-02 / 2020-26 of 16 November 2020,  the Accreditation Body of Serbia (ATS) clients and external associates are being notified that the ATS employees will work from home during the aggravated epidemiological situation caused by the coronavirus (SARS-COV-2), in the period from 16 to 27 November 2020 in such a way to ensures the continuity of business activities, as was done earlier.

ATS continues the implementation of all planned assessments by choosing assessment techniques that provide confidence in competence, regularly reviewing all relevant information received from conformity assessment body and its assessors and experts, taking care to maximally protect the health and safety of each participant in the assessment.

The following rules of communication with ATS shall apply in the specified period:

- documents, reports, and any other records/documented information relevant to the implementation of the accreditation process are forwarded to ATS exclusively via e-mail to the competent contact persons or via the following e-mail address: office@ats.rs;

Note: other parties communicate with ATS via e-mail, by telephone, and exceptionally by regular mail;

- information can also be obtained by telephone at the appropriate telephone numbers listed in the Contacts section: HERE►;

- communication with the ATS employees is enabled via electronic or telephone communication (business mobile phone numbers are used) between 8 AM and 3 PM;

- all answers to questions / requests will, as a rule, be forwarded  to the applicant via e-mail;

- any relevant information on the ATS activities during the aggravated epidemiological situation will be available in a timely manner on the ATS website: HERE►, as well as via Twitter: HERE►

Sincerely, ATS

Annual meeting with assessors (leading/technical) for evaluation of inspection bodies

GeneralNotices

Annual meeting with assessors (leading/technical) for evaluation of inspection bodies


The annual meeitng with assessors (leading/technical) for assessment of inspection bodies was held on November 9, 2020. The meeting was held ’’online’’ using the Cisco Webex platform.

The main topics of the meeting were the following: Guidelines for the implementation of ISO/IEC 17020 standard (ILAC-P15: 05/2020), i.e. the application of the ATS-UP42 document and the Conformity Assessment Modules in accordance with Decision no. 768/2008/ EC with special reference to the link between the mandatory document EA-2/17 M, EA Document on Accreditation for Notification Purposes and ATS-PA08, Areas of activity of ATS, Annex 1. During 2019 and 2020, the number of accredited inspection bodies has significantly increased, so the number of assessments of these bodies were extremely large. The evaluation findings and the use of assessment documents (dilemmas, problems, positive experiences) were also discussed at the  meeting.

At the end of the meeting, the issues initiated by the assessors were discussed, with the aim of improving the quality of the assessment process.


Sincerely, Your ATS

The new issue of the ATS Bulletin no.23

NoticesCurrent eventsPromotion

The new issue of the ATS Bulletin no.23

Dear readers, we proudly present to you the 23rd edition of the ATS Bulletin. The topic of this issue is the new edition of ILAC-P15: 05/2020 for the application of ISO/IEC 17020:2012 - Conformity assessment - Requirements for the operation of various types of bodies performing inspection.

This document is used in the process of assessment of inspection bodies performed by accreditation bodies. Moreover, this document contains information pertaining to inspection bodies with respect to the application of the reference standard. The deadline for its application is November 2021. To familiarize the users with this document, we have presented the changes concerning its previous edition dated 2016 in detail and we have also highlighted the novelties.

The bulletin also refers to the adoption of new and amendments to the existing ATS documents, and EA and EA MLA Reports for 2019. Furthermore, the news from the world of accreditation, metrology, and standardization are contained in the new issue of the ATS Bulletin.

Should you have any comments or suggestions regarding the ATS Bulletin content, feel free to send us to our well-known e-mail address: office@ats.rs

Please find the electronic version of the ATS Bulletin no. 23 - September 2020 edition below

https://www.ats.rs/uploads/attachment/vest/799/ATS_Bilten_br23.pdf

Sincerely, your ATS

Notice to inspection bodies

NoticesCurrent eventsLaws and regulations

Notice to inspection bodies

Regulation on stationary storage tanks

Accredited bodies are being notified that on the day Regulation on stationary storage tanks enters into force ("Official Gazette of RS", No. 50/19), Regulation on metrological requirements for vertical cylindrical tanks ("Official Gazette of SFRY", No. 3/85) shall cease to be valid.

Regulation on metrological requirements for horizontal cylindrical tanks ("Official Gazette of SFRY", No. 26/81) and Metrological guidance on examination of horizontal cylindrical tanks ("DMDM Gazette", No. 3/05) shall cease to be valid on December 31, 2020.

Bearing in mind that the above metrological regulations cease to be valid on December 31, 2020, verification of stationary storage tanks (horizontal cylindrical tanks) by the volumetric method by authorized bodies, without a calibration certificate issued by an accredited laboratory, can be performed until December 31, 2020. After that date, i.e. as of January 1, 2021, the verification of the tank (including the subject ones) will be performed, among other things, on the basis of an appropriate calibration certificate with the result of calibration performed by one of the prescribed methods (including the volumetric one) and issued by an accredited calibration laboratory in accordance with sections 1, 2 and 3 of Annex 2 to Regulation on stationary storage tanks.

Regulation on stationary storage tanks ("Official Gazette of the RS", No. 50/19) does not make changes that would affect modifications in the activities of conformity assessment bodies performing inspection activities. In this regard, and in order to make transition to operating according to the new Regulation, ATS will act as follows:

  • all accredited inspection bodies that have Regulation on metrological requirements for horizontal cylindrical tanks (Official Gazette of SFRY, No. 26/81) and Metrological guidance on examination of horizontal cylindrical tanks by volumetric method ("DMDM Gazette", No. 3/05) in their scopes which cease to be valid on December 31,2020 must submit the documentation proving that they have complied their operation with the requirements of the new Regulation by October 15,  2020 to ATS;
  • based on the submitted documentation, ATS will verify the changes/conformities that have been made by reviewing the submitted documentation and make an appropriate decision on accreditation;
  • if CAB does not submit the necessary documentation proving that it has complied its work with the requirements of the new Regulation, the Accreditation Body of Serbia will make a decision to reduce the scope of accreditation in the part of regulations that cease to be valid.

It is possible that the verification of changes is also assessed on site during the assessment of the conformity assessment body.

Best regards, ATS