International Organisations and Agreements

EU Member States and EFTA countries have established a European network of national accreditation bodies commonly known as the European co-operation for Accreditation (EA) enabling the competence of laboratories, inspection and certification bodies to be assessed against the criteria laid down in international standards and procedures. EA is a non-profit organisation that is given a prime role to define, harmonise and build consistency in accreditation as a service with the aim to reduce barriers to trade and to contribute to the protection of health and safety.

Furthermore, EA was established as the official European accreditation infrastructure in accordance with Regulation (EC) No. 765/2008 of the European Parliament and of the Council of 9 July 2008 establishing a legal framework for accreditation throughout Europe. This Regulation provides that each Member State shall appoint a single national accreditation body that the government shall entrust with the operation of accreditation as a public authority activity and grant it formal recognition in accordance with the requirements of international standards in both the private and public sector.

In addition to EA as the most important regional international organisation acting as the official European accreditation infrastructure, there are international organisations governing accreditation globally - in the field of laboratory, inspection and certification body accreditation. These are the International Laboratory Accreditation Cooperation - ILAC and International Accreditation Forum - IAF.

ILAC and IAF have established and maintain a system of multilateral mutual recognition agreements built upon the regional arrangements existing in Europe (ILAC / IAF MRA / MLA), Asia (ILAC MRA) (APLAC - Asia Pacific Laboratory Accreditation Co-operation for laboratories and inspection), Pacific (IAF MLA) (PAC - Pacific Accreditation Co-operation for certification), America (ILAC / IAF MRA / MLA) (IAAC - Interamerican Accreditation Co-operation) and Africa (IAF MLA) (SADC - Southern African Development Community in Accreditation). Thus, a large number of countries around the world become a part of the system established by ILAC and IAF in order to reduce technical barriers to trade and to establish a harmonised approach to the operation of accreditation bodies worldwide.

International agreements

The task of accreditation bodies as stipulated in the agreements of the European co-operation for Accreditation (EA MLA), International Laboratory Accreditation Cooperation (ILAC MRA) and International Accreditation Forum (IAF MLA) is to promote a system of accreditation and equivalence of accreditation systems. These agreements are signed on the basis of the detailed evaluation of procedures and criteria of the accreditation body (peer evaluation) in question, whereas the peer evaluation is conducted by a team of experts in specific fields of accreditation. A uniform approach used to determine competence of conformity assessment bodies worldwide enables countries to sign mutual agreements on the basis of evaluation and recognition of accreditation systems whereby reducing the number of unnecessary product controls in international trade and creating conditions for free movement of people, goods, services and capital.

EA MLA is an agreement signed between the EA accreditation body members to recognise the equivalence, reliability and therefore acceptance of accredited certifications, inspections, calibration certificates and test reports across Europe (EA Region). In addition to the aforementioned multilateral agreement a country may sign the EA bilateral agreement (BLA) where the difference between the MLA (multilateral) and BLA (bilateral) agreements is essentially a non-existent one, except that the MLA agreement is signed by a country which is a full EA member, while the BLA is signed by an associate member. All obligations of the countries that sign these agreements remain the same.

Enforcement of EA multilateral / bilateral agreements is carried out through peer evaluation conducted by evaluators from other accreditation bodies. The purpose of these rigorous on-site evaluations is to verify the signatories' continuing conformance with the internationally accepted criteria. ABs are evaluated against the international standard - ISO/IEC 17011, Regulation No 765 (EC)/2008, other related criteria such as application documents from EA, ILAC or IAF and applicable criteria on behalf of European or National Regulators and industrial schemes. The MLA process is overseen by the European Commission, the EA Advisory Board and the national authorities.

If you want to learn more about accreditation and national accreditation bodies, signatories to the EA MLA, please visit the EA website at: http://www.european-accreditation.org/home

List of EA members:

http://www.european-accreditation.org/ea-members

To know what the EA MLA signatories for a given scope are, please visit:

http://www.european-accreditation.org/mla-and-bla-signatories

ATS as a signatory to the EA MLA

On the 24th May 2012, ATS became a full EA member and signed the EA MLA for the following fields of accreditation: testing laboratories, medical laboratories, calibration laboratories, inspection bodies, and certification bodies providing certification of products. Moreover, ATS signed the new EA MLA on 27th May 2014 that, in addition to testing, calibration, inspection and product certification, now includes certification of management systems and certification of persons.

The status of the Accreditation Body of Serbia (ATS) as a signatory of the Multilateral agreement (MLA) between ATS and European Co-operation for Accreditation (EA) was unanimously confirmed at the 39th meeting of the EA Multilateral Agreements Committee (MAC) held on April 25 and 26, 2018 at Hyatt Hotel in Belgrade. This great success of the ATS is the outcome and confirmation of peer re-evaluation conducted in the period from September 25 to 29, 2017 and from October 2nd to 6th (only for certification of persons).

The status of signatory to the Multilateral Agreement (MLA) between ATS and EA was confirmed for the fields of testing laboratories, calibration laboratories, medical laboratories, inspection bodies, certification bodies for product certification, certification bodies for certification of management systems and certification bodies for certification of persons.

ATS EA MLA Certificate

ATS as a signatory to the ILAC MRA

On 24th May 2012 ATS became a signatory to the ILAC MRA for testing and calibration, and on 25th October 2012 the ILAC MRA was signed for the field of inspection.

List of ILAC members:

http://ilac.org/ilac-membership/

To know what the ILAC MRA signatories for a given scope are, please visit:

http://ilac.org/signatory-search/

Please check the ATS ILAC MRA Certificate

ATS as a signatory to the IAF MLA

Furthermore, on 25th October 2012 ATS became a signatory to the IAF MLA (Multilateral Recognition Arrangement) in the field of product certification on the basis of the said multilateral agreement with EA, whereas on 6th October 2014 ATS signed the IAF MLA in the field of management system certification and on 20th October 2016 ATS signed the new IAF MLA in the field of certification of persons.

On April 5, 2018, ATS became a signatory for the following sub-scopes within the scope of ​​ management systems certification: Information Security Management Systems (ISMS), Medical Devices Management Systems (MDMS) and Food Safety Management Systems (FSMS).

To know what the IAF MLA signatories for a given scope are, please visit:

http://www.iaf.nu/articles/IAF_Members__Signatories/4

ATS IAF MLA Certificate for product certification

ATS IAF MLA Certificate for management system certification

ATS IAF MLA Certificate for person certification

In addition to international multilateral agreements, accreditation bodies can conclude agreements on bilateral cooperation in the field of accreditation.

ATS has concluded agreements on bilateral cooperation with the following bodies in the region:

1. Institute for Accreditation of Bosnia and Herzegovina (BATA)
2. Accreditation Body of Montenegro (ATCG)
3. Institute for Accreditation of the Republic of Macedonia (IARM)
4. Croatian Accreditation Agency (HAA)
5. Romanian Accreditation Association (RENAR)
6. Slovak Accreditation Service (SNAS)
7. Slovenian Accreditation (SA)
8. Federal Accreditation Service of the Russian Federation (RusAccreditation)
9. Belarusian State Centre for Accreditation (BSCA)
10. Bulgarian Accreditation Service (BAS)
11. Hungarian Accreditation Body (NAH)
12. United Kingdom Accreditation Service (UKAS).

 

EA

European co-operation for Accreditation (EA) is a network of nationally recognised accreditation bodies providing accreditation services of:

Calibration laboratories,
Testing laboratories and medical laboratories,
Inspection bodies,
Certification bodies providing certification of management systems,
Certification bodies providing certification of products,
Certification bodies providing certification of persons,
GHG verifiers in accordance with ISO 14065,
PT providers,
Producers of reference materials.

EA performs its activities on the basis of the Memorandum of Understanding signed between the European Commission and EFTA.

EA member categories include accreditation bodies from EU Member States and EU candidate countries, and EFTA countries. Associate membership category includes national accreditation bodies of the countries that are part of the EU Neighbourhood Policy or potential candidates for EU membership. Obligation of all accreditation bodies is to prove that their accreditation systems operate in accordance with both requirements of the international standard (ISO/IEC 17011) and ILAC/IAF provisions and with Regulation (EC) No 765/2008 and corresponding EA provisions.

EA members reached an agreement on the existence and implementation of common policies in the field of accreditation and mutual recognition which is achieved through signing of a multilateral agreement (EA Multilateral Recognition Agreement). Advisory Board (EAAB) is the EA advisory body and it is composed of representatives of all interested parties from the EU Region.

IAF

International Accreditation Forum (IAF) is the world association of Conformity Assessment Accreditation Bodies and other bodies interested in conformity assessment. Its primary function is to develop a single worldwide programme of conformity assessment to be used globally in order to avoid occurrence of non-tariff barriers to trade.

IAF membership is open to accreditation bodies from all over the world, industry representatives and accredited certification bodies that are obliged, through membership in this international organisation, to promote the implementation of a uniform system of multilateral agreements on mutual recognition of certificates issued by conformity assessment bodies accredited by the said accreditation bodies.

As one of the objectives, IAF is committed to promote trade activities in accordance with the WTO rules on the basis of Mutual Recognition Agreement (MLA) confirming equivalence of accreditation systems of the members through peer evaluation. This system should allow businesses to have their certificates recognised worldwide given that one of the IAF objectives is to promote international recognition of accreditations granted by the accreditation bodies of the IAF members through the recognition of equivalence of their accreditation systems. All IAF members adopt common policies and procedures in order to facilitate free movement of goods, services, people and capital in accordance with the World Trade Organisation's Agreement on Technical Barriers to Trade.

Therefore, IAF motto reads as follows "certified once, accepted everywhere".

Structure of the IAF MLA

The IAF MLA is structured in five levels:

Level 1 - ISO/IEC 17011, specifies mandatory criteria that apply to all accreditation bodies (ABs).

Level 2 - Accreditation Activities, in which the AB has demonstrated competence to perform accreditation as specified by the IAF endorsed generic accreditation normative documents listed in Level 3. IAF MLA accreditation activities are:

  • Management system certification
  • Product certification
  • Certification of persons
  • Validation and Verification

Level 3 - IAF endorsed generic accreditation normative document used by the AB to assess the Conformity Assessment Body (CAB) competence for each accreditation activity. For example:

  • For management system certification - ISO/IEC 17021
  • For product certification - ISO/IEC 17065
  • For certification of persons - ISO/IEC 17024
  • For Greenhouse Gas Validation and Verification - ISO 14065

Level 4 - IAF endorsed sector specific normative documents which specify internationally recognised applications of the generic normative document listed in Level 3. The documents are used by the AB, in combination with the generic normative document listed in Level 3 to assess the CAB competence in the relevant sector. For example:

(a) Normative document to be used in combination with ISO/IEC 17021:

  • For certification of food safety management systems (FSMS) - ISO/TS 22003
  • For certification of information security management systems (ISMS) - ISO/IEC 27006
  • For certification of energy management systems (EnMS) - ISO/TS 50003

(b) Normative documents to be used in combination with ISO/IEC 17065:

  • GLOBALG.A.P. Integrated Farm Assurance General Regulations

(c) Normative documents to be used in combination with ISO/IEC 17024:

  • None currently endorsed

(d) Normative documments to be used in combination with ISO 14065:

  • None currently endoorsed

Level 5 - IAF endorsed conformity assessment normative document used by CABs. For example:
(a) Normative document used by Management System Certification Bodies

  • For certification of Quality Management Systems (QMS) - ISO 9001
  • For certification of Environmental Management Systems (EMS) - ISO 14001
  • For certification of Food Safety Management Systems (FSMS) - ISO 22000
  • For certification of Information Security Management Systems (ISMS) - ISO/IEC 27001
  • For certification of energy management systems (EnMS) - ISO 50001

(b) Normative document used by Product Certification Bodies:

  • GLOBALG.A.P. IFA Control Points and Compliance Criteria

(c) Normative document used by Personnel Certification Bodies:

  • None currently endorsed

(d) Normative documents used by Greenhouse Gas Validation and Verification Bodies:

  • None currently endorsed.

The combination of a Level 2 activity and the Level 3 relevant normative document is called a main scope of the MLA. The attestations made by CABs where the MLA is at the main scope level are considered to be equally reliable. Level 4 and Level 5 do not exist for all main scopes. Level 4 and Level 5 are called the sub-scopes of the MLA. The attestations made by CABs where the MLA is at the sub-scope level are considered to be equivalent.

 

ILAC

International Laboratory Accreditation Cooperation (ILAC) is an international organisation the members of which are national accreditation bodies and other organisations in the field of laboratory testing and inspection. They have signed the Memorandum of Understanding that constitutes a basis for the establishment and further development of multilateral agreement system. In this way test results are recognised globally and technical barriers to trade are eliminated.

ILAC also provides assistance to developing countries that are in the process of developing their own laboratory accreditation systems. These developing systems are able to participate in ILAC as associate members, and access the resources of ILAC's more established members.

In conjunction with ILAC, specific regions have also established their own accreditation co-operations, notably in Europe (EA) and the Asia-Pacific (APLAC), America (IAAC), and Africa (SADC and AFRAC). These regional co-operations work in harmony with ILAC procedures. ILAC is encouraging the development of such regional co-operations in other parts of the globe.

Structure of the ILAC MRA

The ILAC MRA is structured in five levels:

Level 1 - ISO/IEC 17011, specifies mandatory criteria that apply to all accreditation bodies (ABs)

Level 2 - Conformity assessment activities of conformity assessment bodies to which the accreditation body grants accreditation according to the generic, normative documents listed in Level 3

  • Testing
  • Calibration
  • Inspection
  • Proficiency Testing
  • Reference Material Production*

Level 3 - Generic, normative documents used by the AB to assess the conformity assessment body (CAB) competence for each activity in Level 2 are:

  • For Testing: ISO/IEC 17025 and ISO 15189
  • For Calibration: ISO/IEC 17025
  • For Inspection: ISO/IEC 17020
  • For Proficiency Testing: ISO/IEC 17043
  • For Production of Reference Material*: ISO 17034

Level 4 - Sector-specific normative documents which specify internationally recognised applications of the generic, normative document listed in Level 3. These application documents are used by the AB, in combination with the generic, normative documents listed in Level 3, to assess the CAB competence in the relevant sector and are:

(a) Normative documents to be used in combination with ISO/IEC 17025:

  • For anti-doping testing laboratories also accredited by the World Anti-doping Agency (WADA) - the WADA International Standard for Laboratories (ISL)
  • For medical reference measurement laboratories - ISO 15195

(b) Normative documents to be used in combination with ISO 15189:

  • For Point-of-Care Testing - ISO 22870

(c) Normative documents to be used in combination with ISO/IEC 17020:

  • None currently endorsed

(d) Normative documents to be used in combination with ISO/IEC 17043:

  • None currently endorsed

(e) Normative documents to be used in combination with ISO 17034*:

  • None currently endorsed

Level 5 - The scope of accreditation of the CAB accredited by an ILAC Arrangement signatory.

*) The General Assembly endorses the recommendation of the ARC to extend the ILAC Mutual Recognition Arrangement (MRA) to include accreditation of reference material producers to the criteria specified in ISO 17034 according to the Resolution ILAC GA 20.13.