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Role of accreditation in the implementation of CSRD

GeneralLaws and regulations

EU law requires all large companies and medium-sized companies (except listed micro-enterprises) to disclose what they see as the risks and opportunities arising from social and environmental issues and the impact of their activities on people and the environment.

The EU recognizes that companies' transparency and reporting on environmental, social, human rights, and similar issues are key to sustainable development.

This helps investors, civil society organizations, consumers, and other stakeholders to evaluate the sustainability performance of companies, as part of the European Green Deal. 

The European Green Deal is the EU’s sustainable development strategy for the 21st century. The central issue addressed by this strategy is the environment and climate change – how to develop the EU economy without accelerating climate change. The European Commission defines this strategy as ‘’a new growth strategy with the aim of transforming the EU into a fair and wealthy society, with a modern and competitive economy that uses resources efficiently, with net zero greenhouse gas emissions by 2050, and economic growth which is separated from resources exploitation”.

The Corporate Sustainability Reporting Directive (CSRD) entered into force on the 5th of January 2023. This new EU legislation aims to accentuate the growing awareness of environmental, social, and governance factors (ESG factors). One means is moving the publication of information related to firms’ social and environmental responsibility from virtually voluntary to mandatory.

The auditing and reporting processes have been specified in the CSRD and now include the possibility of recognizing accredited Conformity Assessment Bodies (CABs) as independent assurance services providers.

You can view it in detail HERE

ISS published new technical specifications and new standard

NoticesLaws and regulations

The Institute for Standardization of Serbia (ISS) has recently published two new technical specifications from the SRPS ISO/IEC TS 17021 series, Conformity Assessment - Requirements for bodies performing verification and certification of management systems – Part 11 and Part 13.

Both technical specifications are bilingual, in Serbian and English. Part 11 includes additional requirements for the competence of personnel participating in the verification and certification process of management systems for facilities management (FM). In contrast, part 13 relates to the requirements for the competence of personnel for verification and certification of compliance management systems (CMS). They supplement the existing requirements for competence, consistency, and impartiality of bodies that perform validation and certification of all types of management systems, from the SRPS ISO/IEC 17021-1 standard published in 2015.

You can view it in detail HERE

New Regulation about Ecodesign for Products

GeneralNoticesLaws and regulations

The European co-operation for accreditation EA, published on its website news regarding the Ecodesign Directive 2009/125/EC on which improvement the European Commission is working.

Ecodesing of a product is a set of conditions that a product that uses energy shall meet in terms of environmental protection in the period that includes the process of its creation, use, and decommissioning.

This directive has a long track record of delivering benefits to businesses, consumers, and the environment. In 2021 alone, the impact of the current Ecodesign measures, covering 31 product groups, saved 120 billion euros in energy expenditure for EU consumers, leading to a 10% lower annual energy consumption by the products in scope.

You can view it in detail HERE

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


 

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

 

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

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

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

Accreditation for the conformity assessment scheme in the field of measuring instruments that are component of medical devices

NoticesCurrent eventsLaws and regulations

Accreditation for the conformity assessment scheme in the field of measuring instruments that are component of medical devices

Rulebook on Amendments to the Rulebook on measuring instrument types that are subject to legal control ("Official Gazette of RS" No. 13/18, 45/19, 93/20) has been amended and entered into force on July 9, 2020. The Rulebook has been amended in such a way that the measuring instruments that are component of medical devices (no. 35 and no. 36 of the Table in Article 2) have been added, and which, according to Article 7, are verified by designated bodies. They must be accredited according to Article 9 of the Law on metrology ("Official Gazette of RS" No. 15/16).

In "Official Gazette of RS" no. 92/2020, the following Rulebooks have been published:

  • the Rulebook on electrocardiograph verification
  • the Rulebook on verification of measuring instruments that are component of Dialyzers
  • the Rulebook on verification of measuring instruments that are component of Defibrillators
  • the Rulebook on verification of measuring instruments that are component of Anesthesia Sets
  • the Rulebook on verification of measuring instruments that are component of Infusion and Perfusion pumps
  • the Rulebook on verification of  measuring instruments that are component of multifunctional devices for patient monitoring
  • the Rulebook on verification of measuring instruments that are component of ultrasonic physiotherapy devices
  • the Rulebook on verification of measuring instruments that are component of respirators
  • the Rulebook on the verification of measuring instruments that are component of neonatal and pediatric incubators and resuscitation hot tables
  • the Rulebook on the verification of measuring instruments that are component of high-frequency surgical knives and high-frequency surgical accessories.

All the activities regarding extending the field of ​ATS operation in this field of ​​conformity assessment have been completed as well in accordance with its procedures. Also, the document ATS-PA08, Fields of ATS activity, was updated.

The extension of all transition arrangements

NoticesCurrent eventsLaws and regulations

The extension of all transition arrangements

Due to the current situation caused by the COVID-19 pandemic, International Accreditation Forum (IAF) has extended all transition arrangements for transition/migration to new versions of the standard by 6 months, and the transition periods are now as follows:

  • for the standard ISO 45001: 2018 - September 30, 2021,
  • for the standard ISO 22000: 2018 - December 31, 2021,
  • for the standard ISO 50001: 2018 - January 31, 2022,
  • for the standard ISO 22301: 2019 - April 30, 2023.

IAF still recommends that transition checks should be performed using remote assessment techniques.

IAF has also extended the deadlines for the implementation of mandatory documents by 6 months, so now the deadline for the implementation of IAF MD5:2019, IAF MD17:2019 and IAF MD22: 2019 is November 7, 2020.

We encourage all certification bodies to follow the answers to the most frequently asked questions IAF regularly updates regarding accreditation and certification during the COVID-19 pandemic at https://iaffaq.com.

Should you have any questions, do not hesitate to contact ATS via e-mail: office@ats.rs.

Sincerely, your ATS

The statement on the abolition of the state of emergency in the Republic of Serbia

NoticesCurrent eventsLaws and regulations

The statement on the abolition of the state of emergency in the Republic of Serbia

To Whomever It May Concern,

In these challenging times, we are fully aware of the limitations the coronavirus pandemic has imposed on both our professional and personal lifestyles. In the light of this, all the measures have been taken to mitigate the consequences as much as possible, but the fact is they have made a significant impact on our lives.

It is immensely important for all of us to protect our health and ensure safety for each individual, continuing our business activities, which is our common goal when it comes to ensuring confidence in the validity of the testing/calibration/proficiency testing/inspection/certification results.

For this purpose, and bearing in mind the adoption of the Decision on the abolition of the state of emergency in the Republic of Serbia ("Official Gazette of RS", No. 65/2020 of May 6, 2020), ATS will continue its previous activities using all assessment techniques in the future (including on-site assessment), but the decision on the techniques that will be applied and in within what time frame will be made taking into account the risk analysis of conformity assessment activities performed within the scope of accreditation including a detailed risk analysis of each assessment techniques, and the on-site assessment.

The assessments at the ATS location will commence on June 8, 2020, by undertaking all the necessary measures recommended by the Government of the Republic of Serbia. If necessary and if all the necessary conditions for on-site assessment are met, they can be planned before the specified date.

In addition to following all official measures, it is up to us to implement additional safety measures that will protect health and ensure safety for each individual during the assessment.

Please keep in mind that the continuation of our business and goals such as the implementation of assessment in the planned time, obtaining accreditation, maintaining accreditation, extending the scope of accreditation, the transition to a new edition of the standard, in addition to trust in competence, will be based on confidence in safety, and on the fact that we have done everything in our power to protect the health of each individual.

In order to carry out our joint work in a planned and efficient manner, ATS will request from the accredited bodies, as well as those in the accreditation process, the relevant information necessary to perform the analysis and make a decision on upcoming assessments, as well as techniques to be used.

We wish you health and professional success. Also, we are at your disposal for all the necessary information.

the ATS Acting Director
prof. Aco Janicijevic, PhD

EA-INF/05: 2020 and the EA Horizontal Harmonization Committee (EA HHC) documents published

NoticesLaws and regulations

EA-INF/05: 2020 and the EA Horizontal Harmonization Committee (EA HHC) documents published

Given there are around 115 EU regulations (regulations and directives) related to accreditation and conformity assessment, the EA-INF/05:2020 Register of these regulations has been published on the website of the European co-operation for Accreditation (EA). This shows the great importance of the role and value of accreditation in Europe.

In order to support the accreditation bodies that are EA members, a comprehensive Register of EU regulations related to accreditation and conformity assessment has been established.

The register is available at the following link:

Also, the EA Horizontal Harmonization Committee (EA HHC) documents which passed the voting of the EA members were published on the EA website.

Those are:

  • the new edition of the document EA-1/22 EA Procedure and Criteria for the Evaluation of Conformity Assessment Schemes by EA, which shall come into force in April 2021.

You can view the document here:

  • the new edition of the document EA Document on Accreditation For Notification Purposes that all national accreditation bodies must apply as of April 2021.

You can view the document here:

  • the new guidelines EA-2/20 EA-2/20 Consultancy, and the Independence of Conformity Assessment Bodies, which enters into force in April 2021 and represents the EA approach (what is acceptable behavior and what is not) during the assessment of independence of conformity assessment bodies. This document defines the EA approach to assessing the independence of conformity assessment bodies (CAB) and of these CABs’ (third party) conformity assessment activities performed for notification purposes and for certification of products, processes and services, in relation to consultancy activities and other activities outside the accreditation scope. The stated requirements apply whatever accreditation standard is used.

You can view the document here:

Sincerely, your ATS

Additional announcement related to COVID-19

NoticesCurrent eventsLaws and regulations

Additional announcement regarding the state of emergency declared throughout the Republic of Serbia

Even in these changed circumstances such as the state of emergency declared throughout the Republic of Serbia introduced according to the Declaration of a State of Emergency (“Official Gazette of the RS”, no. 29/2020), ATS continues its activities by taking the utmost care to protect its clients, assessors, and employees.

On the basis of the Regulation on the Organisation of Employers during the State of Emergency (“Official Gazette of the RS” No. 31/2020), ATS has organised all of its employees to work from home to ensure their activities are being continued. Therefore, all employees will be available via means of electronic and telephone communication, and all the additional information you need can be obtained from one of the provided contacts: HERE ►.

The ATS has decided to conduct all the assessments scheduled for this period by the end of the state of emergency, using one of the permitted assessment techniques, except for the conformity assessment body (CAB) on-site assessment, or performing assessment at the location where CAB conducts its activities. Different means of communication that are yet to be agreed with CAB (e.g. skype, chats, video call…) may be used during these assessments.

See announcement for full details: HERE ►.

We hope that we will overcome this unfortunate situation together.

Sincerely, your ATS

Administrative fee

Laws and regulations

On 16th July 2011, the Law on the Amendments to the Law on Republic Administrative Fees entered into force (“Official Gazette of the Republic of Serbia”, No.50/11) and it contains the change in the amount of administrative fees for the submission of ap...

Law on Accreditation was adopted

Laws and regulations

On 12th October the Serbian Parliament adopted the Law on Accreditation. Adoption of the Law on Accreditation as the last one in the field of quality infrastructure in the Republic of Serbia heralded the fulfilment of one of the necessary prerequisit...

Government adopted the Bill on Accreditation

Laws and regulations

On Thursday, 10th June the Government of the Republic of Serbia adopted the Bill on Accreditation at its 273rd session. The said Law shall govern accreditation, status and work of the national accreditation body in the Republic of Serbia, and other iss...

Public hearing on the Accreditation Bill

Laws and regulations

A public hearing on the Accreditation Bill was held on 26th March at the premises of the Serbian Chamber of Commerce. Vidosava Džagić, Vice President of the Serbian Chamber of Commerce, and Jelena Popović, Assistant Minister at the Ministry of Economy ...

Newly adopted EU Regulation

Laws and regulations

1st July 2008 - Newly adopted EU Regulation – on the movement of goods on the single market, accreditation and market surveillance COUNCIL OF THE EUROPEAN UNION Luxemburg, 23rd June 2008 11062/08 (Press186) Council adopted rules to improve f...