News

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 adoption of new and amendments to the existing ATS documents

In the previous period, the Accreditation Body of Serbia adopted several documents, but also amendments to existing documents, as follows:

• the amended Rules ATS-PA05, rules of cross-frontier Accreditation, complied with the mandatory document EA-2/13 M: 2019, EA Cross Border Accreditation Policy and Procedure for Cross Border Cooperation between EA Members were adopted. The EA document also contains answers to the most frequently asked questions regarding the application of the document, which can be found on the ATS website.
• the amended guidance document entitled Accreditation of  Flexible Scope of Accreditation ATS-UP28 was adopted; the document is in accordance with the mandatory document EA-2/15 M: 2019, EA Requirements for the Accreditation of Flexible Scope;
• the document ATS-UP41, Evaluation of Conformity Assessment Schemes was developed; this guidance applies to the evaluation of conformity assessment schemes to determine their suitability for the intended use and accreditation. It also defines the Report on the Evaluation of the Conformity Assessment Scheme, formed by the owner of the conformity assessment scheme prior to establishing contact with ATS.

All documents can be found on the ATS website:

Sincerely, your ATS

 

TRANSITION PERIOD FOR ISO/IEC 17025 EXTENDED

As a result of the recent ILAC ballot the transition period for ISO/IEC 17025:2017 adopted as part of the ILAC Resolution GA 20.15 (November 2016) has been extended from 30 November 2020 to 1 June 2021. This extension has been granted to ensure all accreditation bodies and the accredited laboratories are able to achieve the remaining transitions in a robust manner under the restrictions imposed as a result of the global coronavirus disease 2019 (COVID-19) outbreak.

At the end of the transition period, the accreditation of a laboratory to ISO/IEC 17025:2005 will not be recognised under the ILAC Arrangement.  The ISO/ILAC ISO/IEC 17025:2017 Transition Communique available from https://ilac.org/about-ilac/partnerships/international-partners/iso/  has been updated to reflect this extension to the transition period.

The Accreditation Body of Serbia will continue the implementation of the remaining transitions through the assessments that are to come (as planned). It will be enabled, however, that assessments shall be implemented in such a way to include the necessary timeline difference with respect to the original plans, taking into account the circumstances resulting from the global pandemic, as well as the detailed risk analysis.

According to the current dynamics and information provided by accredited testing and calibration laboratories, it is planned that, all assessments will be completed by the end of November 2020 that will include the transition to the new edition of the standard.

 

Celebrating the World Accreditation Day and the Accreditation Day in the Republic of Serbia

World Accreditation Day (June 9) and Accreditation Day in the Republic of Serbia (June 28)

The Accreditation Body of Serbia (ATS) organized a celebration on June 9, on the occasion of marking the World Accreditation Day. The attention was also paid to the Accreditation Day in the Republic of Serbia, celebrated on June 28, when ATS issued the first accreditation certificate  20 years ago. The celebration was held on the premises of the Klub poslanika in Belgrade.

The topic of this year's World Accreditation Day, jointly established by ILAC (International Laboratory Accreditation Cooperation) and the IAF (International Accreditation Forum) to promote the value of accreditation, is: Accreditation - improves food safety. This topic focuses on how accreditation supports food safety by strengthening the trust of consumers, suppliers, customers, and other parties involved in the food chain. The celebration highlighted the importance of accreditation in the field of food safety. Furthermore, the attention was paid to accreditation providing competent and impartial inspection, certification, and testing services in all parts of local, national, and international food chains. Moreover, accreditation supports the United Nations' sustainable development goals, especially the one related to good health and well-being.

In these challenging times caused by the coronavirus, COVID-19 pandemic the entire quality infrastructure system including accreditation, the healthcare system, and accredited laboratories promptly responded to the task thus making an undeniable contribution to the successful implementation of safety measures implemented by the government of our country. The celebration was held taking the circumstances into account and following the prescribed safety measures. As in previous years, it was dedicated to all accredited conformity assessment bodies, assessors and experts, the ATS employees, and other parties in the world of accreditation. Without their dedicated, competent, and responsible work, it would not be possible to fight coronavirus pandemics.

The representatives of public institutions and universities, members of the ATS bodies and organs, and its technical committees attended the ceremony.

Aleksandar Starcevic, Acting Assistant Minister of Economy, addressed the audience on behalf of the Sector for Product Quality and Safety of the Ministry of Economy. He spoke about the role of the Ministry of Economy that is the coordinator for technical regulations and the body responsible for creating the strategy and implementing the policy of development of standardization, accreditation, and metrology. Additionally, he highlighted the accreditation-related benefits not only for consumers and suppliers but also for the entire economy.

Zoran Djordjevic, Minister for Labor, Employment, Veteran and Social Affairs of the Republic of Serbia, also addressed the audience, welcoming this gathering on behalf of the Government of the Republic of Serbia. He emphasized the importance of ATS cooperation with this and other ministries regarding adopting standards and laws in different areas in which accreditation also has a role to play aiming to improve life in general by setting the standards at the highest level.

The ATS Acting Director, prof. Aco Janicijevic, PhD spoke about the ATS activities in the past period, key points in the development of the accreditation system in the past 22 years of existence and functioning of ATS, accreditation schemes, international cooperation, and plans for the future. On this occasion, he pointed out there was an increase in the number of accredited bodies, which reached the figure of 707, whereas the number of leading and technical evaluators and technical experts also grew. He also proudly stated the EA Multilateral Agreement Council (EA MAC), decided on the transition of the ATS from ISO/IEC 17011: 2004 to the new edition of the ISO/IEC 17011:2017 on May 26, 2020. The decision was made by online voting based on the ATS Self-Assessment Report documentary assessment by the Team Leader. Consequently, ATS has confirmed the previously signed EA MLA agreement on mutual recognition of the equivalence of accreditation systems signed by EA members' accreditation bodies recognizing the equivalence and reliability of reports and certificates issued by conformity assessment bodies across Europe (EA region) accredited by the accreditation bodies of the signatories of the agreement. It was also announced that a peer evaluation would be performed by the European co-operation for Accreditation (EA) at the end of 2021.

As the topic of this year's World Accreditation Day was related to food safety, prof. Aco Janicijevic, PhD emphasized that ATS accredited testing laboratories according to SRPS ISO/IEC 17025 for a large number of methods of chemical, sensory, and microbiological testing. Areas of accreditation include testing of products for human use, including food (plant, animal origin), drinking water tasting, and accreditation in the field of certification of food safety management systems according to SRPS ISO 22000. The product certification schemes under which ATS accredits are the Law on Organic Production ("Official Gazette of RS" No. 30/10) and the Law on Geographical Indications ("Official Gazette of RS" No. 18/10).

Close attention was paid to the first accredited bodies that received the first accreditation certificate issued by ATS exactly 20 years ago. These are "Kvalitet ad Nis and North Control d.o.o. Subotica." Prof. Aco Janićijevic, PhD delivered the thank you note to Vladimir Vukasinovic, the CEO of "Kvalitet ad Nis and Slobodan Gajin, PhD,  the CEO of “North Control d.o.o. Subotica” on the occasion of celebrating the 20th anniversary of the first accreditation being granted - June 28, 2000, 22 years since ATS was founded and the World Accreditation Day - June 9.

For many years, the Accreditation Body of Serbia has been implementing the policy of promoting signed agreements with international organizations such as the European co-operation for Accreditation (EA), the International Laboratory Accreditation Cooperation (ILAC), and the International Accreditation Forum (IAF). The representatives of these organizations extended their congratulations to ATS on the occasion of celebrating the World Accreditation Day and the 20th anniversary of the first accreditation being granted. Eti Feller, General Manager of ISRAC (Israel Labaratory Accreditation Authority) and ILAC Chair, Xiao Jianhua Chief Executive of CNAS (China National Accreditation Service for Conformity Assessment) and IAF Chair and  Ignacio Pina, EA Chair contributed to the ATS celebration by sending video links sharing their words of praise.

A short promotional film "World Accreditation day 2020. Accreditation: Improving food safety" made on the occasion of celebrating the World Accreditation Day 2020 was played with a subtitle in Serbian, which you can watch here.

Taking into account the slogan of this year's World Accreditation Day was Accreditation - improves food safety, the guests of the ceremony were addressed by the director of the Directorate for National Reference Laboratories, Nenad Dolovac, Ph.D. who spoke about experiences in food safety and the importance of accreditation.

The guests had the opportunity to enjoy the Balkan String Trio members guitar playing, which made this day even more beautiful. This unique trio consists of Zoran, Nikola and Zeljko Starcevic, whose trademark is six-handed playing on one guitar. Everyone was enthusiastic about the unique interpretation of the best Balkan guitarists mixing a synthesis of various Balkan elements: Serbian, Gypsy, Macedonian, Romanian, Moldavian, Hungarian, and others.

Natalija Jovicic Zaric, MSc, who was also the moderator of the event, wished everyone on behalf of ATS to stay safe until the next meeting.

Best wishes!
Your ATS

 

 

The Accreditation Body of Serbia has made a successful transition to the new edition of the ISO/IEC 17011:2017

On May 26, 2020, the EA Multilateral Agreement Council (EA MAC) made a decision confirming the ATS successful transition from ISO/IEC 17011:2004 to the new edition of ISO/IEC 17011:2017. It was made by online voting based on the ATS Self-Assessment Report documentary assessment by the team leader.

Hence, ATS has confirmed the previously signed EA MLA on mutual recognition of the equivalence of accreditation systems signed by the EA members' accreditation bodies recognizing the equivalence and reliability of reports and certificates issued by conformity assessment bodies across Europe (the EA region). According to the EA MLA Council (EA MAC) schedule, there will be a regular peer evaluation of ATS on site by EA at the end of 2021.

The decision to make a transition to the new edition of ISO/IEC 17011:2017 is available here.

Sincerely, your ATS

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

ATS continues regular work activities on its premises

The Accreditation Body of Serbia (ATS) continues regular work activities on its premises in Vlajkovićeva no. 3 as of May 18, 2020.

Based on the Decision of the Accreditation Body of Serbia no. 1-02/2020-9 dated May 14, 2020, the ATS employees, who, according to Decision no. 1-02/2020-6 dated March 17, 2020, used to work from home as of May 18, 2020, due to the state of emergency, are gradually getting used to office-based work conditions on the ATS premises according to the Work Plan of employees for the period from May 18-31, 2020.

Taking the Decision on the abolition of the state of emergency ("Official Gazette of the RS", No. 65/2020 dated May 6, 2020) into account, the recommendations of the Ministry of Labor, Veteran and Social Affairs stipulate that ATS allows its employees to work from home even after the abolition of the state of emergency until regular work conditions are fully met pursuant Decision of the Accreditation Body of Serbia No. 1-02/2020-8 as of May 7, 2020, and this decision (dated May 14, 2020) was made to ensure the safe return of the employees, preventing COVID-19 spreading and achieving the continuity of the ATS activities.

Sincerely, ATS

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 MLA Report 2019

EA MLA Report 2019 published

The European co-operation for Accreditation (EA) published the EA MLA Report 2019 on its website on April 14, 2020.

The EA MLA Report 2019 provides information on the activities of the EA Multilateral Agreement Committee (EA MAC) responsible for the efficient and impartial management and monitoring of peer evaluation. It also makes decisions related to the status of a signatory to a multilateral (EA MLA) or bilateral agreement (EA BLA) on the equivalence of the accreditation system at the level of EA or the European Union (EU). Additionally, the report provides an overview of the key activities implemented in 2019, as well as the decisions made regarding the signatories.

The EA MLA is an agreement signed between national accreditation bodies - successfully peer evaluated EA Full and Associate Members - to recognize the equivalence, reliability and acceptance by the European market of certification, verification, inspection and calibration certificates and test reports issued by accredited conformity assessment bodies.

The EA MLA provides the European market with a network of conformity assessment bodies that are competent within their scope of accreditation to issue reliable and credible statements of conformity for products and services, thereby reducing costs and adding value to business and consumers. This contributes to the freedom of trade by eliminating technical barriers.

The main goal of peer evaluation activities is to assess the ongoing compliance of NABs with the internationally agreed requirements. Next, one of their objectives is to ensure that the regulator, stakeholders, and businesses can have confidence in certificates and reports issued by accredited conformity assessment bodies under the EA MLA.

Within the EA MLA/BLA has been signed by 34 EA members so far, the following decisions were made by the EA MLA Council (EA MAC) during 2019 related to extending the signed scope of the agreement or signing a new field of ​​the agreement:

Activities in May:

- National Accreditation Authority (NAH) became a signatory to the EA MLA in the field of proficiency testing providers;

- Slovenian Accreditation, became a signatory of the EA MLA in the field of medical examinations;

- SNAS, Slovak National Accreditation Service, became a signatory to the EA MLA in the field of proficiency testing providers;

-Turkish Accreditation Agency (TURKAK), become a signatory of the EA MLA in the field of  Greenhouse Gas Validation and Verification.

Activities in October:

- the German national accreditation body DAkkS, became a signatory of the EA MLA agreement in the field of manufacturers of reference materials according to the ISO 17034 standard;

- Georgian National Accreditation Body became a signatory of the EA BLA in the field of medical examinations according to the ISO 15189.

Since 2017, EA has extended the scope of the EA MLA for reference materials producers (RMP) according to EN ISO 17034. After the first peer evaluations and the first successfully evaluated members in 2018, the scope of the EA MLA was extended in 2019 for seven signatories to this agreement for reference materials producers (RMP).

Also, the scope of the EA MLA was extended in November 2019, by the decision of the General Assembly, to the field of ​​"Validation and Verification", and the EA MLA standard level 3 was adopted standard EN ISO/IEC 17029: Conformity Assessment-General principles and requirements for validation and verification bodies was adopted as a new EA MLA standard level 3.

Peer evaluations according to the new version of EN ISO/IEC 17011 progressed very well in 2019, when about one-third of the signatories of the EA MLA successfully made the transition from the previous version of the standard. Decisions regarding the transition of other signatories to the EA MLA must be made by November 2020.

EA has become the first regional group to sign the ILAC MRA for Proficiency Testing Provider (PT providers) Accreditation under ISO/IEC 17043.

MAC Chair, Paulo Tavares (IPAC, Portugal), points out that we will face significant challenges in the future. The COVID-19 pandemic, which will contribute to the current unfavorable situation worldwide as well as the financial crisis will have an impact on the infrastructure for conformity assessment. He adds that strong, but also flexible systems of accreditation and peer evaluation are vital for maintaining trust in the public service provided by accreditation bodies.

You can download the EA MLA Report 2019 here.

The new edition of the ATS Bulletin no. 22

We are pleased to present the new edition of the ATS Bulletin no. 22 which we publish in these extraordinary circumstances. Therefore, the main topic of this issue is living with coronavirus in terms of the measures and activities undertaken by ATS in this period to carry out its work smoothly and be at the service of all conformity assessment bodies as well as other stakeholders. This edition also provides an overview of the basic measures taken by other accreditation bodies as well as proposals from international organizations regarding the work of conformity assessment bodies during the coronavirus pandemic.

In addition to this topic, which is, unfortunately, unavoidable worldwide, the ATS Bulletin once again presents news from the world of metrology and standardization in a recognizable style.

Should you have any comments or suggestions regarding the content of the bulletin, do not hesitate to send us to our e-mail: office@ats.rs.

Sincerely, your ATS

You can download  the ATS Bulletin no. 22: here

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

The Annual Report of the Accreditation Body of Serbia for 2019

We present the Annual Report of the Accreditation Body of Serbia for 2019

The Annual Report of the Accreditation Body of Serbia for 2019, adopted by the ATS MB provides information and data on the ATS activities in the past year, as well as the achieved results and goals for 2020.

The previous year was marked by the transition to the new edition of SRPS ISO/IEC 17011: 2018 defining the work of accreditation bodies, as well as the transition to the new edition of  SRPS ISO/IEC 17025:2017, which is to be continued this year, too. Also, in 2019, ATS maintained all signed agreements such as EA MLA, ILAC MRA, and IAF MLA and actively participated in regional and other international conferences. In addition, it took part in the work of all EA committees and their working groups.

As ATS fosters a sincere approach, any suggestions from you are welcome. In addition, we would like you to read our Annual Report with great care.

Your ATS

The Annual Report of the Accreditation Body of Serbia for 2019 can be downloaded: here

The ATS activities in changed circumstances

In these changed circumstances, ATS is continuing its activities: five remote assessments were performed, 40 final-phase assessments were prepared, and 50 decisions on accreditation were made.

We tend to inform our clients and users of their services through our website and Twitter and we shall continue doing so in the future.

We follow the requests of international organizations for accreditation with respect to the application of binding documents. We regularly inform you about this matter, as well as the activities we undertake in this regard.

We made a Decision on the ATS work in this period containing clear rules on how to act, and we informed you about it. We have formed the instructions necessary to perform a remote assessment, as well as the rules regarding performing assessments using different assessment techniques. We informed our assessors about that.

In addition, we have changed our working methods to protect our clients, assessors, and employees.

Always by your side, ATS

The amendment of the rules ATS-PA04 dated April 6, 2020

The amended Rules for the Use of the Accreditation Symbol, Reference to Accreditation and ATS Status as a Signatory to the EA MLA, ILAC MRA and IAF MLA ATS-PA04 available on the ATS website were adopted.

The amended Rules ATS-PA04 are complied with the mandatory documents EA or ILAC, as follows: EA-3/01 EA Conditions for the use of Accreditation Symbols, Logos and other claims of accreditation and reference to the EA MLA Signatory status (beginning of application November 2020) and  ILAC-P8:03/2019, ILAC Mutual Recognition Arrangement (Arrangement) – Supplementary Requirements for the Use of Accreditation Symbols and for Claims of Accreditation Status by Accredited Conformity Assessment Bodies (the beginning of implementation March 2020).

The amended Rules, among other things, define the manner of using the accreditation symbols on certificates of conformity issued by accredited conformity assessment bodies (the item 5.6 of the Rules).

Sincerely, your ATS

The EA release: Impact of the COVID-19 pandemic outbreak

The European co-operation for Accreditation (EA) published a statement on its website on the impact of the outbreak of the COVID-19 epidemic, as follows:

Due to the outbreak of the coronavirus disease 2019 (COVID-19) and the subsequent travel restrictions established by national governments in the vast majority of countries both conformity assessment and accreditation activities have been seriously affected in different ways. In particular, conformity assessment bodies (CABs) and national accreditation bodies (NABs) are being forced to cancel or postpone most of their “in situ” activities such as on-site assessments, audits, witnessing visits and inspections and they will have to face the situation of only being able to provide their services with a workforce that that is now mostly working remotely. This will affect the service provided and also lead to a possible temporary lack of access to certain supplies or services normally subcontracted by the CABs.

Under these circumstances although not all the applicable standards foresee the use of remote assessment techniques, including document reviews, and recognizing that these assessment techniques may not always enable exactly the same objective to be achieved as on-site assessments, EA suggests the use of these techniques whenever needed to substitute or complement on-site assessments.

Nevertheless EA recognises that, in certain circumstances, accredited CABs and NABs will have to take difficult decisions that could include stopping the provision of certain services or temporarily deviating, in order to be able to provide the services, from certain requirements included in the standards or in the accreditation rules.

When facing these situations, both EA members and accredited CABs are required to act responsibly, to analyse the risk of providing services with deviations from the requirements and not to provide them if such deviations jeopardize the technical validity of that specific activity. EA also expects EA NABs and accredited CABs to act with full transparency, informing affected clients of any change in the procedures and keeping records justifying the decisions taken.

Accreditation is an international activity so we recommend both NABs and accredited CABs to visit the ILAC and IAF websites where they can find useful information regarding aspects of global impact. This information also contains valuable information regarding required transition periods like the transition of laboratories to ISO/IEC 17025:2017.

For activities performed in the regulatory field or under a specific scheme CABs must seek information from scheme owners or relevant competent authorities on how they expect related conformity assessment activities should be handled under these circumstances.

As the situation is constantly changing and different countries are establishing different measures to adapt to it, accredited CABs should contact their NAB for further details or questions.

EA will closely follow the development of the coronavirus crisis in order to take any further action when needed and will publish more specific advice and relevant information.

Further information from IAF: https://iaffaq.com

Further information from ILAC: https://ilac.org/latest_ilac_news/potential-impact-of-coronavirus-outbreak-on-accreditation-activities

Sincerely, your ATS

IAF Frequently Asked Questions list: COVID-19

Call to action for all certification bodies to follow IAF guidelines

All certification bodies are invited to follow the IAF guidelines given at https://iaffaq.com/  through the FAQ Forum regarding the new situation related to COVID-19, and accredited certification.

In order to address some of your doubts, IAF has published the answers to the most frequently asked questions (https://iaffaq.com/) regarding the situation on its website. The answers are being updated on a daily basis, so it is necessary for accredited certification bodies to regularly monitor the forum.

Should you have any questions, do not hesitate to contact Natalija Jovicic Zaric MSc, Assistant Director of Development and Quality via e-mail: office@ats.rs

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

Announcement to all certification bodies regarding the occurrence of the coronavirus 

As you have been informed earlier on our website https://www.ats.rs/en/new/2020/03/release, Accreditation Body of Serbia (ATS) is continuously monitoring the situation regarding the coronavirus outbreak. In line with this, ATS informs all certification bodies to follow the instructions given in ID3: 2011 (IAF Informative Document For Management of Extraordinary Events or Circumstances Affecting ABs, CABs and Certified Organizations) regarding contingency management that may affect the work of certification bodies, especially concerning potential changes to the schedule of certification audits, or the introduction of other audit techniques that can be used in this situation.

If certification bodies choose to use information and communication technologies enabling remote audit providing support and maintaining the integrity of the audit, they, consequently, need to implement the mandatory IAF MD 4 (ICT) Mandatory Document for the Use of Information and Communication Technology (ICT) for Auditing/Assessment Purposes).

Should you have any questions, please do not hesitate to contact Natalia Jovicic Zaric, the ATS Assistant Director via e-mail natalija.jovicic_zaric@ats.rs. 

For more information click: HERE ►

Yours sincerely, ATS

Conduct on-site assessments of CABs between March 16^th and March 31^st 2020

Monitoring the situation regarding the outbreak of the coronavirus as well as the activities that are being conducted in our country (https://covid19.rs/homepage-english/) we have taken preventive actions to protect our employees, assessors, and experts, as well as accredited CABs.

 

On this occasion, we inform you that we will not conduct on-site assessments of CABs between March 16^th and March 31^st 2020. We will, however, conduct any planned assessments during this period using any other assessment techniques in accordance with SRPS ISO/IEC 17011:2018. Each CAB shall be informed about how the assessment is going to be conducted.

Any additional information will be communicated on time according to the relevant ATS decisions.

Kind regards, ATS