Annual seminar entitled “Multilateral agreements – international passport to trade” for accredited conformity assessment bodies (CABs) traditionally organised by the Accreditation Body of Serbia (ATS) was held on 2nd June 2014 at the Sava Centre.
The seminar was attended by the representatives of respective ministries, companies, Association of Accredited CABs, and by representatives of accredited CABs. The present delegates were informed about the novelties related primarily to the formal signing of the EA MLA that, in addition to testing, calibration, inspection and product certification, included certification of management systems and certification of persons. Signing of this Agreement enabled ATS to become the first national institution the operation of which was harmonised with the EU legislation and international standards and hence recognised by relevant EU institutions.
The first opening address was given by Snježana Pupavac MSc, Chair of the ATS Management Board, when she stressed the importance of the EA MLA for the Serbian economy and importance of ATS cooperation with the Association of Accredited CABs for the development of the Serbian accreditation and conformity assessment systems.
Snježana Pupavac MSc, Chair of the ATS Management Board
Freek Janmaat, Head of the European Integration Section, Delegation of the European Union to the Republic of Serbia, gave a speech thereafter when he addressed the delegates in the spirit of the EA motto “accredited once, accepted everywhere” given that ATS worked hard to extend the scope of previously signed EA MLA. He then informed the present delegates about the EU IPA 2013 funds to be used for the upgrade of the Serbian quality infrastructure especially as regards the purchase of laboratory equipment and implementation of the new twinning project aiming at the upgrade of the CAB operation.
Freek Janmaat, Delegation of the European Union to the Republic of Serbia
Helmut Mairhofer, Head of the Project QI Component of the GIZ/ACCESS Programme for Private Sector Development in Serbia, said that the ATS cooperation with its respective ministry (Ministry of Economy) and other ministries was crucial since the governmental support was needed for further development of this field having extreme importance to the upgrade of the Serbian economy and market competitiveness.
Helmut Mairhofer, GIZ/ACCESS Programme
During her opening address Vida Živković MSc, Director of the Directorate of Measures and Precious Metals (DMDM), highlighted the importance of joint development of accreditation and metrology and further upgrade of cooperation between DMDM and ATS.
Vida Živković MSc, DMDM Director
Ivan Krstić MSc, Director of the Institute for Standardization of Serbia (ISS), wished for ATS endeavours to continue in order to upgrade the Serbian accreditation system since signing of the EA MLA was a huge success for both ATS and Serbian economy.
Ivan Krstić MSc, ISS Director
Dušan Stokić MSc, Secretary of the Board of Environmental Protection and Sustainable Development, addressed the delegates on behalf of the Serbian Chamber of Commerce (PKS) and stressed the importance of PKS cooperation with the Ministry of Economy and ATS. Given that the Republic of Serbia is faced with explanatory and bilateral screening sessions for all negotiating groups on its path to EU membership, Mr Stokić stressed that PKS representatives took part in 29 negotiating groups which was of great importance to our economy.
Dušan Stokić MSc, PKS
The last opening address was given by Jelena Popović MSc, ME Assistant Minister, when she congratulated all ATS employees for the success that had been achieved and reiterated the importance of the EA MLA, following which she officially opened the seminar and gave a lecture on the subject of “Free movement of goods in the Republic of Serbia”. During her lecture she explained the importance of transposition of EU directives and regulations and said that 14 directives had been transposed so far and that crystal glass directive (No. 15) would be transposed in 2014. The QI Sector updates on a regular basis the lists of Serbian standards the application of which enabled product conformance, whereas guidance documents for business community were produced to further explain regulations on LVD, EMC, machinery, lifts, PPE, textile and footwear. The Ministry of Economy (ME) applies the Cooperation Protocol signed between ME, Trade Inspectorate and Customs Directorate for the purpose of efficient application of new technical regulations, whereas a large number of seminars were organised in order to train the business community in the application of the new technical regulations. It is necessary to emphasise that progress was made in all quality infrastructure (QI) institutions given that the goal of the Strategy for the QI Development 2014-2020 aimed at harmonised development of all QI components (standardisation, accreditation, metrology, conformity assessment), i.e. stable and sustainable QI system harmonised with needs of and plans for the Serbian industry development. When it comes to EU accession process it is necessary to highlight that a serious challenge thereto relates to products for which there are no harmonised technical regulations at EU level (so called non-harmonised area). This area covers a large number of products (e.g. children’s playgrounds – amusement parks, precious metal articles, large number of measuring instrument types – only about 10% of measuring instrument types are harmonised), while regulations governing this area shall be reported to the European Commission as it has to be checked if these create unnecessary barriers to trade. Ms Popović explained that Negotiating Group 1, NG1, (given that accreditation is an integral part thereof) has the most complex structure and scope when compared with remaining chapters of the EU Acquis given that more than 80% of the EU Acquis to be transposed is covered by this NG (over 2,600 regulations where full harmonisation is needed). Moreover, NG1 has 17 sub-groups as proposed by the Croatain colleagues that shared their experiences with the NG1 members as part of the “Support to the EU integration process in Serbia“ GIZ project activities. At the end she stressed that questions to be answered by the European Commission during the explanatory screening were being prepared and analysed (more than 100 questions) given that the explanatory screening had been scheduled for June 2014. This is underpinned by the drafting of the presentations that will be given during the bilateral screening in September 2014.
Jelena Popović MSc, ME
During her presentation “Multilateral agreements – international passport to trade” Jasna Stojanović, ATS Acting Director, introduced the present delegates to the ATS membership in EA, International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) and explained the ATS status at global accreditation level and recognition of certificates of conformity. Moreover, she presented the new ATS activities (accreditation of PT & ILC providers as per SRPS ISO/IEC 17043, CAB accreditation in the field of PPE, forensic science, ATEX regulation, MID, NAWI), and activities related to transition to the new versions of standards (ISO/IEC 17024:2012, ISO/IEC 17065:2012 and ISO15189:2012) in keeping with internationally set deadlines. ATS worked on the upgrade of competence of its employees and external assessors and experts, and it received significant assistance from experts working on the GIZ programme “Support of the Quality Infrastructure in Serbia“, regional PTB project “Promotion of regional cooperation in South Eastern Europe in the field of quality infrastructure”, regional IPA 2011 project “Quality Infrastructure in the Western Balkans and Turkey” that commenced in August 2011 and will end in June 2014, “twinning“ EU project “Creation of a Monitoring, Reporting and Verification System for the Successful Implementation of EU Emissions Trading System“ and EU project “Law enforcement in the field of industrial pollution control, prevention of chemical accidents and establishing the EMAS system”.
Jasna Stojanović, ATS, and Ljubiša Dimitrijević, Secretary of the Association of Accredited CABs
Moreover, the importance of intensive cooperation with accreditation bodies in the region (ATCG, BATA, IARM and HAA) was highlighted, including national QI institutions (DMDM and ISS). The focus was also on the fact that ATS participated in the work of the Board of the Association of Accredited CABs that was established within the Serbian Chamber of Commerce (PKS) in June 2013.
Biljana Tomić, Head of the Department for Legal and General Affairs, ATS, gave a lecture on the subject of “Appeals resolution: process conducted by ATS“ when she explained that ATS was, like any other accreditation body, obliged to put in place a procedure for resolution of complaints filed by CABs, and hence ATS adopted its procedure for resolution of complaints and appeals (ATS-PR16). The delegates were able to learn about the adverse decisions that CABs could complain against (refuse application for accreditation; refuse to continue with the assessment; changes in the scope of accreditation; decisions to refuse, reduce, suspend or withdraw accreditation; any other action preventing the accreditation granting), whereas the Appeals Committee shall decide thereon within 30 days from the date of the appeal receipt. Committee members should be competent and independent from the item the appeal relates to and they must not be the same ones that were directly or indirectly involved in or connected to activities that the appeal relates to. Analysis of the appeals filed in the period between 2010 and 2013 showed that majority of appeals were not justifiable, and that majority of appeals related to the application of the ATS-PA02 document, failure to participate in PT schemes or participation in PT schemes with unsatisfactory results. It was encouraging to see that 10 CABs submitted evidence of satisfactory participation in PT schemes following which ATS made decisions to extend the scope of accreditation.
Biljana Tomić, ATS
In addition to appeal resolution, it was necessary to explain complaint resolution procedure and hence Bratislav Milošević PhD, Assistant Director of Accreditation Affairs, ATS, gave a presentation “Complaints resolution: process conducted by ATS“. Complaints can refer to the ATS work processes that include work processes of the ATS employees and external assessors and technical experts, and complaints about the work of accredited CABs. The ATS Director reviews a complaint and forms a Complaint Resolution Committee. By reviewing and resolving complaints ATS can also collect information that can be used to improve its management system. ATS can undertake some activities as a consequence of the complaint resolution process and these can pertain to ATS, external assessors/technical experts and accredited CABs. Analysis of complaints showed that majority of complaints pertained to the CAB operation, while a small number thereof pertained to the ATS operation, accreditation file managers and assessors. Number of justifiable and unjustifiable complaints was practicaly the same in the period between 2010 and 2012, while there were only 20% of justifiable complaints in 2013. As with appeals, occurrence of justifiable and unjustifiable complaints shows operational breakdowns of both CABs and ATS, and is a basis for undertaking activities to eliminate thereof given that they contribute to continuous upgrade of the CAB and ATS operation.
Bratislav Milošević PhD, ATS
Ljiljana Markićević, Head of the Laboratory Department, ATS, gave a lecture on the subject of “Requirements of the reference standard that a special attention should be paid to (SPRS ISO/IEC 17025)“ when she explained experiences related to the application of this standard as regards the most frequent problems identified during assessments and possible solutions to the said problems. The fact that is of extreme importance relates to the requirement for top management to be responsible for policy decisions, provision of funds and resources for the implementation and maintenance of management system with constant dedication to its upgrade and development. Laboratories have to constantly upgrade the effectiveness of their management systems by applying quality policy, quality objectives, check results, data analysis, corrective and preventive actions, management reviews, and by carrying out internal audits that are performed by trained and qualified personnel. It was stressed that standard methods should be given priority given that these were published in international, regional or national standards. Finally, all requirements of the standard must be fulfilled in the best possible way, whereas it has to be taken into consideration that the system has to be suitable for the scope of activities performed by a laboratory, including efficient, functional and optimum use thereof.
Ljiljana Markićević, ATS
Ljubinka Gligić PhD, Senior Adviser, ATS, gave a lecture on the subject of “What activities should be carried out to harmonise with the requirements of SRPS EN ISO15189:2014” and informed the present delegates that transitional period for the application of the new version of EN ISO 15189 (EN ISO 15189:2012) was 1st March 2016 when accreditations granted as per the previous version of the standard would cease to be valid. Services provided by a laboratory have to fulfil the requirements of patients and all clinical personnel responsible for patient care. Special attention was dedicated to management-related requirements and technical requirements pertaining to pre-examination, examination and post-examination. She also explained the meaning of the term “referral laboratory“ given that it was different from “reference laboratory“. Typical characteristic of SRPS EN ISO 15189:2014 refers to ethical behaviour (respecting patient’s dignity, privacy and independence), whereas attention should be paid to potential conflicts, procedures related to human samples, tissues and remains in keeping with relevant legal requirements (Good Clinical Laboratory Practice Guidelines) and information confidentiality maintenance.
Ljubinka Gligić PhD, ATS
Natalija Jovičić Zarić MSc, Deputy Director, ATS, gave a lecture on the subject of “Threats to impartiality – problematic requirements (SPRS ISO/IEC 17020:2012)“ and instantly explained the meaning of the terms “impartial“ and “independent“ given that these were crucial for the operation of inspection bodies (IBs). IBs must at all times identify the risks to their impartiality and they have to be able to demonstrate how they can eliminate such risks or keep such risks to minimum (other tasks of organisation and personnel, property, contracts, subcontractors). Hence she informed the present delegates that the Accreditation Body of Serbia (ATS) produced, in cooperation with ad-hoc technical committees for inspection and certification bodies, the document entitled “General Impartiality Principles”. Threats from IB interests and check of their own work were stressed given that there were direct or indirect interests for clients, excessive dependence on fees paid by clients, fear from losing clients, relationship between salary rates and number/results of contracted activities, close relationship with clients or clients can put pressure or make threats. The conclusion related to the fact that ICs could attain acceptable level of impartiality if risks could be identified and actions defined, and keep risks to minimum.
Natalija Jovičić Zarić MSc, ATS
Ljubica Živanić, Head of the Inspection and Certification Department, ATS, focused, during her lecture “Certification body structural requirements – organisational structure-related requirements (SPRS ISO/IEC 17065:2013)“, on legal responsibilities, mechanisms to safeguard impartiality, validation, review and certification decision-making, resolution of appeals and complaints, surveillance, obligations of certification bodies (CBs) in case of certification termination, reduction, suspension or withdrawal. The focus was on the issues that CBs were not allowed to do, whereas the CB organisational structure had to be documented – defined duties, responsibilities and competences of management and other certification employees and all committees. When a CB is part of a legal entity, then its structure has to include competence levels and relation to other parts of the same legal entity. In case of certification termination or reduction CBs have to: undertake actions specified by the certification scheme, make all necessary changes to official certification documents, public information, authorisation to use marks, etc. When certification is suspended, persons have to be competent in terms of knowledge and understanding of all aspects relating to handling of suspended certifications.
Ljubica Živanić, ATS
Jovana Zečević, Senior Adviser, ATS, gave a lecture on the subject of “Auditor competence – novelty that provides upgrade of quality (SPRS ISO/IEC 17021:2011)“ during which she explained that it was necessary to determine competence criteria for functions specified in normative Annex A to the standard, and all other functions involved in the certification procedure. Specific competence criteria are specified in: SRPS ISO/TS 22003:2010 Food safety management systems - Requirements for bodies providing audit and certification of food safety management systems, SRPS ISO/IEC TS 17021 - 2:2013 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 2: Competence requirements for auditing and certification of environmental management systems, SRPS ISO/IEC TS 17021-3:2014 Conformity assessment - Requirements for bodies providing audit and certification of management systems - Part 3: Competence requirements for auditing and certification of quality management systems. ATS will undertake all necessary activities in the next period in order to harmonise CB assessment procedure with the requirements of SRPS ISO/IEC TS 17021 - 2:2013, while mandatory application will commence on 2nd May 2015. ATS will start assessing application of the TS requirements on 1st October 2014.
Jovana Zečević, ATS
The last seminar lecture on the subject of “Acceptability of certification schemes – important aspect of marketing (SPRS ISO/IEC 17065:2013 and (SPRS ISO/IEC 17024:2012)“ was given by Ljubica Živanić and Natalija Jovičić Zarić MSc. Mandatory elements of certification schemes were first mentioned together with the mode of certification scheme validation when it was explained that SRPS ISO/IEC 17065 did not specify the requirements for schemes and their development and that it was not intended to limit the role or scheme owner selection procedure, whereas scheme requirements should not be contrary to or excluding any of the requirements of this international standard. A general instruction on how to develop schemes is specified in ISO/IEC 17067 in combination with ISO/IEC Guide 28 and ISO/IEC Guide 53. SRPS ISO/IEC 17065 defines that the scheme has to specify certification activities together with product/process/service requirements. A certification scheme has to clearly describe requested competence, it has to include certification subject and scope, while competence requirements that are assessed have to be clearly described including description of requirements that has to be easily understandable for target groups. However, competence requirements have to be based on a clear description and analysis of job descriptions, and mode to evaluate competence. Furthermore, it was mentioned that the scheme had to contain a description of the mode in which surveillance and recertification would be carried out, whereas a certificate had to be in keeping with the assessment that had been carried out. Conditions to maintain and reasons for suspension or withdrawal of certificates have to be defined, and if the certification mark is used, ISO/IEC 17030 requirements have to be applied.