"MRA" is the acronym for "Mutual Recognition Arrangement". A complex framework and structure applies in the creation and application of the global MRA for accreditation of laboratories and inspection bodies.
The basis for the international MRA, administered by the International Laboratory Accreditation Cooperation (ILAC), is the recognition of accreditation bodies (ABs) by approved regional accreditation co-operations.
The ILAC-recognised regions that have functioning MRAs and evaluation procedures currently include the Asia Pacific Laboratory Accreditation Cooperation (APLAC), the European cooperation for Accreditation (EA) and the Inter-American Accreditation Cooperation (IAAC).
Individual ABs undergo an intensive peer evaluation conducted by the regional cooperation within which they are located. This evaluation includes a program of review of on-site assessment processes.
The aim of a peer evaluation is to confirm the "equivalence" of the accreditation practices of the AB under evaluation with other ABs in that region. During this process, an MRA signatory or applicant is required to demonstrate compliance with the international standard, ISO/IEC 17011, and other ILAC and regional requirements, and that its accredited facilities are in compliance with relevant standards such as ISO/IEC 17025 (laboratories) and ISO/IEC 17020 (inspection bodies).
Regional evaluations of individual ABs are performed every four years and regional co-operations are in turn evaluated by ILAC for equivalence with other ILAC-recognised regions, also every four years.
ABs that have been recognised as signatories within a region are eligible to apply for ILAC signatory recognition.
The premise behind all of these evaluations and regional and international co-operations is that the facilities accredited by the MRA signatories as they are known, can in turn be recognised as producing reliable results within their scope of accreditation. This allows the end user, no matter where they are located, to accept test reports from facilities accredited by MRA signatories assuming that the scope of accreditation is appropriate to the needs of that user. This removes the need for retesting and can lead to reduced costs and time in regard to the trading of goods.
The MRAs were initially established to allow the free movement of goods and services where any required testing, calibration and inspection of these goods and services was supported by accreditation through the regional co-operations such as APLAC, or ILAC where no regional cooperation exists.
In more recent years, the use of the MRAs has been extended to include the cross-border sharing of data and images such as in teleradiology and telemedicine.
The practical effect of MRAs is that costs associated with testing, calibration and/or inspection to importers and exporters would be minimised. The concept of “tested once, accepted everywhere” would also allow goods and services supported by accredited testing, calibration and/or inspection to reach the market more quickly.
The MRAs are intended to provide the end-user with the confidence to accept test reports from facilities accredited by MRA signatories, where the scope of accreditation is appropriate. This then removes the need for retesting and reduces costs and time in regard to the trading of goods, for both the exporter and the importer.
According to the APLAC web site, “the APLAC MRA forms a regional network of laboratories and inspection bodies accredited by accreditation bodies that have been peer-evaluated and recognised as being competent. This network facilitates the acceptance of test, calibration and inspection reports in the region, thus contributing to the facilitation of trade and the free-trade goal of tested/inspected once, accepted everywhere”.
For the MRA to work on a practical level, it must be supported and promoted by MRA signatories themselves, as a first step.
For this reason, an MRA signatory is required:
- to recognise the accreditation of a laboratory, inspection body (or reference material producer in the APLAC region), by other signatories to the MRA, as being equivalent to an accreditation by its own organisation;
- to accept endorsed calibration, test or inspection reports (or reference materials certificates) issued by laboratories, inspection bodies (or reference material producers) accredited by other MRA signatories, on the same basis as it accepts endorsed calibration, test or inspection reports issued by its own accredited laboratories and/or inspection bodies; and,
- to recommend and promote the acceptance by users in its economy of endorsed test, calibration, and inspection reports (or reference material certificates) issued by organisations accredited by other signatories.
It should be said that the decision to accept test reports from facilities accredited by MRA signatories is entirely that of the end-user.
It is therefore important that the end-user is informed about a number of key issues when making this decision. These include:
- Does the facility have accreditation for the actual tests required by the end-user?
- Is the report appropriately endorsed?
- Does the test report actually relate to the goods that are in question in a meaningful way as far as the end-users specifications are concerned?
What Assistance Can NATA Provide to End-Users?
NATA may be able to assist end-users in their decision process about accepting test/calibration/inspection reports from MRA partner accredited facilities, by providing a contact point in the accreditation body in the exporting country.
NATA can also assist with enquiries about test/calibration/inspection reports.
Please refer to "Enquiries about the MRA" for more information on this.
NATA is a signatory to, or recognised through, not only the ILAC and APLAC MRAs, but also arrangements associated with the Organisation for Economic Cooperation (OECD) and the European Community (EC). Some details on each of these can be found below.
1. APLAC MRA
NATA is an inaugural APLAC MRA signatory for testing, calibration, reference material producer and inspection accreditation; and ILAC for calibration, testing and inspection. (There is no ILAC MRA for reference material producers at this time.)
(According to the APLAC website, one of the primary aims of APLAC is to harmonise accreditation practices in the region and to extend the APLAC Mutual Recognition Arrangement (MRA). The inaugural signing of the APLAC MRA was in Tokyo on 19 November 1997 when seven APLAC Full members, including NATA, signed.
2. Designated Compliance Monitoring Authority for OECD GLP
NATA is designated by the Commonwealth government as Australia’s national compliance monitoring authority for Good Laboratory Practice (GLP), and represents Australia on the Organisation for Economic Co-operation and Development (OECD) Working Group for GLP. NATA’s GLP staff also participate in onsite evaluations of other national GLP compliance monitoring programs.
3. NATA’s Role in the EC-MRA
NATA is recognised as the designating authority for four of the six sectoral annexes to the European Community-Australia Government-to-Government Mutual Recognition Arrangement. The four annexes are electromagnetic compatibility (EMC), low voltage electrical equipment, machinery and pressure equipment.
(The other two annexes (medical devices and pharmaceuticals-Good Manufacturing Practice) are designated by a separate body, the Australian Therapeutic Goods Administration (TGA).)
Funding for participation in MRA Activities
NATA is greatly assisted in its capacity to participate in international activities due to funding provided by the Commonwealth government. This is provided through the Support for Industry Service Organisations (SISO) program administered by the Department of Industry (DI).
Activities associated with the OECD Panel on GLP receive full funding and ILAC and APLAC activities receive substantial funding. Where involvement in trade negotiations or related work are involved, special funding may also be provided.
In the case of MRAs, this support allows NATA staff to participate in peer evaluations and the APLAC MRA Council and ILAC Arrangement Council, as relevant. The latter two bodies are responsible for reviewing peer evaluation reports and conducting an adversarial discussion on the outcomes of the evaluations of MRA signatories, at the point of initial admission to the MRA, and on an ongoing basis.
NATA staff participation in MRA Evaluations
NATA currently has seven APLAC MRA evaluators on staff and aims to provide at least three evaluators annually for participation in regional peer evaluations when requested.
Limitations to NATA’s offshore accreditation activities resulting from the MRA
In keeping with the undertakings of an MRA signatory, NATA does not actively seek to offer accreditation services in the economies of MRA partners and NATA’s practices are in accordance with the principles of ILAC G21:2012 Cross Frontier Accreditation-Principles for Cooperation.
NATA may however consider offering accreditation services outside of Australia where no national MRA partner is operating or when the scope of accreditation by that partner does not cover that of the potential applicant.
Consideration will also be given to requests from Australian businesses operating offshore where accreditation by NATA is preferred.