Introduction
The EA Multilateral Agreement (EA MLA) is a signed agreement between the EA Members whereby the signatories recognize and accept the equivalence of the accreditation systems operated by the signing members, and also the reliability of the conformity assessment results provided by Conformity Assessment Bodies (CABs) accredited by the signing members. It makes the objective ‘Accredited once, accepted everywhere’ effective.
Acceptance in the marketplace of the EA MLA and thereby of conformity assessment results provided by CABs accredited by EA MLA signatories is of major importance for the internal market in Europe in facilitating cross border trade as well as in demonstrating compliance with European legislation for products and services contributing to protect health, safety and the environment.
The EA MLA is signed between the EA Members.
Regulation (EC) No 765/2008
National authorities shall recognize the equivalence of the services delivered by those National Accreditation Bodies (NAB) which have successfully undergone EA peer evaluation (EA MLA signatories) and thereby accept the accreditation certificates of those bodies and the attestations issued by the Conformity Assessment Bodies accredited by them.
How to ensure that your certificate or test report is acceptable
The mark of an EA MLA signatory on certificates and reports issued by accredited Conformity Assessment Bodies acts as a “passport to trade”. The confidence this accreditation brings eliminates the need for suppliers to be certified in each country in which they sell their products or services, and therefore provides the framework for goods and services to cross borders in Europe and throughout the world.
Five steps to check the reliability of a certificate or a report: |
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1 | Check that there is an accreditation mark on the report or certificate. |
2 | Check that the accreditation mark is of a National Accreditation Body (NAB) signatory to the EA, ILAC or IAF MLA. |
3 | Check that your supplier is accredited for the competence, the tests and the results you need. |
4 | Check that the tests have been carried out against international standards. Alternatively, check that the standards and methods used can be accepted in the country of destination. |
5 | In case of problems, contact the NAB. |
It is possible to ascertain whether the NAB is a signatory for the scope by checking the directory of EA MLA signatories.
Coverage
The EA Multilateral Agreement (EA MLA) covers the following conformity assessment activities and standards:
Accreditation scope/Activities | Standards used for accreditation |
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Laboratories Testing and Medical examination |
EN ISO/IEC 17025 EN ISO 15189 |
Laboratories Calibration |
EN ISO/IEC 17025 |
Certification Bodies Product certification |
EN ISO/IEC 17065 |
Certification Bodies Certification of persons |
EN ISO/IEC 17024 |
Certification Bodies Management systems certification |
EN ISO/IEC 17021-1 |
Inspection Inspection |
EN ISO/IEC 17020 |
Validation and Verification Bodies GreenHouse Gas (GHG) Validation and Verification |
EN ISO 14065 EN ISO/IEC 17029 |
Proficiency Testing Providers (PTP) Proficiency Testing Providers |
EN ISO/IEC 17043 |
Reference Materials Producers (RMP) Reference Materials Producers |
EN ISO 17034 |
Biobanking Biobanks |
EN ISO 20387 |
EA MLA for Biobanking
The EA General Assembly decided to expand the EA MLA for biobanking as a level 2 conformity assessment activity using EN ISO 20387 as a new level 3 normative document.
The EA Multilateral Agreement Council concluded all arrangements, including the training of its members, who are making the decisions, to start with the peer evaluations of EA National Accreditation Bodies.
All conformity assessment results (e.g. reports and certificates) provided by Conformity Assessment Bodies accredited by an EA MLA signatory are considered to be under the EA MLA provided that the conformity assessment results issued by the CAB contain a reference to the relevant accreditation.
Regulation (EC) No 765/2008 places an obligation on EU Member States to accept results issued by the conformity assessment bodies accredited by any of the EA MLA signatories. This clearly removes the need for a product to be re-tested or re-certified when marketed on different markets in the EU, provided that the certificate is covered by valid accreditation.
To confirm equivalence of accreditation activities or validity of reports and certificates issued by accredited bodies, EA Members can use EA-INF/04 Statement on acceptance and recognition of activities under the EA MLA and issue a “statement of equivalence” in response to requests made by regulators or other users.
Benefits
The EA MLA provides a framework to realize the objective ‘Accredited once, accepted everywhere’.
For national governments and regulators
- Supporting implementation of European and national legislations by confirming compliance with standards and applicable requirements;
- Enhancing trade and economic growth by giving governments confidence in accreditation and competent suppliers of goods and services;
- Limiting costs and resources by eliminating a number of administrative obligations. The EA MLA reduces the need to employ specialized assessment personnel for regulatory controls and avoids duplication of audits.
For industry and the business community
- Boosting competitiveness: with the EA MLA, businesses can differentiate their services by providing objective evidence of technical competence, impartiality and compliance with international requirements and avoid the costs of re-testing;
- Reducing controls and increasing quality: importing goods and services with an EA MLA accredited report or certificate can be both less risky and cheaper as businesses do not need to provide additional evidence;
- Supporting export: as the EA MLA is recognized internationally, its opens new opportunities on the global market by eliminating barriers to trade.
For Consumers and Citizens
- Creating trust: consumers’ confidence in the market is enhanced when they know that the products and services they choose are controlled by an independent and competent body which is itself regularly assessed by an impartial body;
- Operating in the public interest: all along the supply chain, consumers’ interest is safeguarded by the EA MLA Signatories who act as “checkers of checkers”.
- Providing citizens and consumers with a better and safer environment, and better healthcare services by guaranteeing the compliance of products and services with European legislations
FAQ
A harmonised standard is a European standard developed by a recognised European Standards Organisation: CEN, CENELEC, or ETSI. It is created following a request or mandate from the European Commission to one of these organisations. Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation. When a product is designed or manufactured following harmonized standards, it means that the product is in line with corresponding EU rules. In other words, the product benefits then from the presumption of conformity.
Presumption of conformity exists when a product is designed or manufactured in accordance with harmonized standards.
We talk here about presumption of conformity with the accessibility requirements set out in Directive (EU)2019/882.