ILAC Mutual Recognition Arrangement:

Scope and Obligations

ILAC-P5:06/2022
 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

About ILAC

ILAC is the global association for the accreditation of laboratories, inspection bodies, proficiency testing

providers, reference material producers and biobanks, with a membership consisting of accreditation

bodies, regional cooperation bodies and stakeholder organisations throughout the world.

It is a representative organisation that is involved with:

 the development of accreditation practices and procedures,

 the promotion of accreditation as a trade facilitation tool,

 supporting the provision of local and national services,

 the assistance of developing accreditation systems,

 the recognition of competent testing (including medical) and calibration laboratories, inspection

bodies, proficiency testing providers, reference material producers and biobanks around the

world.

ILAC actively cooperates with other relevant international organisations in pursuing these aims.

ILAC facilitates trade and supports regulators by operating a worldwide mutual recognition arrangement –

the ILAC Arrangement - among Accreditation Bodies (ABs). The data and results issued by laboratories,

inspection bodies, proficiency testing providers, reference materials producers and biobanks collectively

known as Conformity Assessment Bodies (CABs), accredited by ILAC Accreditation Body members are

accepted globally via the ILAC Arrangement. Thereby, technical barriers to trade, such as the re-testing of

products each time they enter a new economy is reduced, in support of realising the free-trade goal of

“accredited once, accepted everywhere”.

In addition, accreditation reduces risk for business and its customers by assuring that accredited CABs are

competent to carry out the work they undertake within their scope of accreditation.

Further, the results from accredited facilities are used extensively by regulators for the public benefit in the

provision of services that promote an unpolluted environment, safe food, clean water, energy, health and

social care services.

Accreditation Bodies that are members of ILAC and the CABs they accredit are required to comply with

appropriate international standards and the applicable ILAC application documents for the consistent

implementation of those standards.

Accreditation Bodies having signed the ILAC Arrangement are subject to peer evaluation via formally

established and recognised regional cooperation bodies using ILAC rules and procedures prior to becoming

a signatory to the ILAC Arrangement.

The ILAC website provides a range of information on topics covering accreditation, conformity

assessment, trade facilitation, as well as the contact details of members. Further information to illustrate the

value of accredited conformity assessment to regulators and the public sector through case studies and

independent research can also be found at www.publicsectorassurance.org.

For more information, please contact:

The ILAC Secretariat

PO Box 7507

Silverwater NSW 2128

Australia

Phone: +61 2 9736 8374

Email: ilac@nata.com.au

Website: www.ilac.org

@ILAC_Official

https://www.youtube.com/user/IAFandILAC

© Copyright ILAC 2022

ILAC encourages the authorised reproduction of its publications, or parts thereof, by organisations wishing

to use such material for areas related to education, standardisation, accreditation, or other purposes relevant

to ILAC’s area of expertise or endeavour. The document in which the reproduced material appears must

contain a statement acknowledging ILAC’s contribution to the document.
 

 

 

 

 

 

 

ILAC-P5:06/2022

ILAC Mutual Recognition Arrangement: Scope and Obligations

TABLE OF CONTENTS

PREAMBLE .........................................................................................................................................................4

PURPOSE

ANNEX B - GENERIC POLICY FOR TRANSITION PERIODS FOR IMPLEMENTATION OF

.............................................................................................................................................................4

AUTHORSHIP .....................................................................................................................................................5

MUTUAL RECOGNITION ARRANGEMENT: SCOPE AND OBLIGATIONS.........................................5

ANNEX A - ILAC ARRANGEMENT SIGNATURE SHEET.........................................................................7

REVISED STANDARDS.....................................................................................................................................8

ANNEX C - REVISION TABLE ........................................................................................................................9

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ILAC Mutual Recognition Arrangement: Scope and Obligations

PREAMBLE

This document describes the elements of the ILAC Mutual Recognition Arrangement (hereinafter

referred to as the ILAC Arrangement) for the accreditation of conformity assessment bodies (CABs)

in accordance with ILAC R6 Structure of the ILAC Mutual Recognition Arrangement and Procedure

for Expansion of the Scope of the ILAC Arrangement. Signatories to the ILAC Arrangement

recognise with mutual confidence one another’s accreditations within each signatory’s scope of

recognition under the ILAC Arrangement. The ILAC Arrangement Signature Sheet, signed by each

signatory to the ILAC Arrangement, is shown in Annex A.

The ILAC Arrangement is a major co-operative effort to enhance the objective of free trade

throughout the world, support the implementation of a quality infrastructure and improve the supply

of public benefit services such as health, water, food and energy. The criteria for the operation of the

accreditation bodies and accredited CABs are currently specified in ILAC R6.

ILAC R6 also provides details relating to the structure and defined levels of the ILAC Arrangement.

The principal elements for establishing confidence among the participating accreditation bodies are

listed below. These elements are designed to ensure conformity with the requirements of the

standards which is verified by on-going peer evaluations, in order to establish and maintain mutual

confidence in the technical competence of signatories to the ILAC Arrangement and their accredited

CABs. The elements are:

1. Participation in the work and decision making of the ILAC General Assembly, ILAC

Arrangement Council and ILAC committees and regional cooperations where applicable;

2. Participation in the work of ILAC with other scientific and technical organisations to address

issues related to testing, calibration, inspection, biobanking, provision of proficiency testing

programs and production of reference materials in various technical fields;

3. Exchange of information on the development and operation of accreditation schemes of ILAC

members;

4. Evaluations of applicants and re-evaluations of signatories to the ILAC Arrangement in

accordance with the relevant ILAC and joint IAF/ILAC documents and documents issued by

recognised regional cooperations; and

5. Observations of assessments undertaken by applicant accreditation bodies and ILAC

Arrangement signatories, during which the bodies determine whether the CABs meet the

requirements of the standards for CABs identified in ILAC R6.

The ILAC Arrangement does not affect other recognition required by laws and regulations in the

economies of the signatories but can be used to support such recognition programs.

PURPOSE

To provide details of the scope and policies of the ILAC MRA as well as the obligations of the

signatories to the ILAC Arrangement.

This document is effective from the date of publication on the ILAC website.

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ILAC Mutual Recognition Arrangement: Scope and Obligations

AUTHORSHIP

Key revision to this document by the ILAC Arrangement Management Committee (AMC) and the

ILAC Arrangement Committee (ARC) occurred in:

 2011 to include the accreditation of inspection bodies;

 2016 to include the policy for transition periods for the implementation of revised standards

covered by the ILAC Arrangement and to include the accreditation of proficiency testing

providers;

 2017 to include the accreditation of reference material producers; and

 2022 to include the accreditation of biobanks.

MUTUAL RECOGNITION ARRANGEMENT: Scope and Obligations

1. The ILAC Arrangement is based on the results of the evaluations carried out in accordance

with the relevant standards, rules, policies and procedures contained in the ILAC mandatory

and IAF/ILAC A series documents.

2. Each recognised regional cooperation body shall abide by the requirements defined in

IAF/ILAC A1.

3. Each accreditation body signatory to the ILAC Arrangement agrees to:

(i) Abide by its terms and conditions,

(ii) Maintain conformity with ISO/IEC 17011, the supplementary requirements defined in

the IAF/ILAC A2 document and relevant ILAC mandatory and IAF/ILAC A series

documents,

(iii) Ensure that all accredited CABs comply with the relevant standard listed in ILAC R6

and relevant ILAC mandatory and ILAC/IAF A-series documents, and

(iv) Upon changes to requirements of the ILAC Arrangement, ensure conformity with the

new requirements within the period specified by the ILAC General Assembly.

4. Each signatory:

(i) recognises within its scope of recognition of the ILAC Arrangement the accreditation of

a CAB by other signatories as being equivalent to an accreditation by its own

accreditation body,

(ii) accepts, for its own purposes, endorsed certificates or reports* issued by CABs

accredited by other signatories on the same basis as it accepts endorsed certificates or

reports issued by its own accredited CABs,

* The definition of “endorsed certificate or report” is detailed in ILAC P8.

(iii) recommends and promotes the acceptance by users in its economy of endorsed

certificates and reports issued by CABs accredited by a signatory to the ILAC

Arrangement for the relevant scope,

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ILAC-P5:06/2022

ILAC Mutual Recognition Arrangement: Scope and Obligations

(iv) investigates all complaints initiated by other signatories to the ILAC Arrangement

resulting from certificates or reports issued by the CABs it has accredited within its

accreditation schemes,

(v) notifies the ILAC Secretariat as soon as possible of any significant changes affecting its

ability to fulfil the requirements for recognition for level 2 conformity assessment

activities or level 3 documents, or major organisation changes,

(vi) contributes to the work of the ILAC Arrangement Council,

(vii) participates in the work of ILAC including committees and voting in ballots,

(viii) provides evaluators for the evaluations of accreditation bodies and regional cooperations

as appropriate to its size and to the needs of the AMC with the concurrence of the

affected recognised regional cooperation,

(ix) co-operates with other accreditation bodies so that the ILAC Arrangement may be

extended to include other accreditation bodies and regional co-operations, and

(x) uses all information obtained from the peer evaluation process in a confidential and

professional manner

5. To participate in the ILAC Arrangement, an accreditation body shall be evaluated in

accordance with the relevant rules and procedures defined in the IAF/ILAC A series and ILAC

mandatory documents and shall complete a signature sheet authorised by the ILAC

Arrangement Council Chair (Annex A of the ILAC Arrangement). The same procedures shall

be followed if a decision is taken to extend its scope of recognition.

6. The scope of recognition of a signatory may be extended or reduced following re-evaluation in

accordance with the relevant rules, policies and procedures.

7. If a signatory wishes to withdraw from the ILAC Arrangement, or withdraw parts of its scope

of recognition for any reason whatsoever, that body shall notify the ILAC Secretariat in writing

not later than three months in advance of withdrawal. The ILAC Secretariat shall notify other

signatories. Upon withdrawal of a body, that body’s signature sheet shall be deleted and the list

of signatories amended accordingly.

8. In the event of the ILAC Arrangement Council making an adverse decision or finding against a

signatory, the procedures for appeal are defined in ILAC P4.

9. Any amendment of the text of the ILAC Arrangement shall be approved by the ILAC General

Assembly.

10. It is recognised and accepted by each of the signatories that the ILAC Arrangement does not

create any rights, liabilities or obligations that would have binding effect in domestic or

international law. The ILAC Arrangement by itself does not provide any recognition or

accreditation under any law or regulation in the economy of any signatory.

11. The ILAC Arrangement consists of twelve (12) clauses plus three Annexes.

12. The ILAC Arrangement takes effect upon signing by both the signatory accreditation body and

the Chair of the ILAC Arrangement Council.

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ANNEX A - ILAC ARRANGEMENT SIGNATURE SHEET

ILAC MUTUAL RECOGNITION ARRANGEMENT

SIGNATORIES

We, the undersigned, endorse the terms of the ILAC Arrangement and agree to abide by them, to the

best of our ability.

Accreditation Body:

Economy:

Scope and date:

Authorised Representative:

Signature: _____________________________ Date:

Chair, ILAC Arrangement Council:

Signature: _____________________________ Date:

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ANNEX B - Generic Policy for Transition Periods for Implementation of Revised Standards

When revised standards are published, ILAC decides on the transition period for the implementation

of the revised standard. After the close of the transition period, the information provided by the

accreditation body to the accredited conformity assessment body (eg the accreditation certificates)

shall appropriately reference the revised standard. Compliance is determined during normal

surveillance or reassessment activities or as a separate activity.

After the close of the transition period, conformity assessment bodies accredited to older versions of

the revised standard will not be recognised under the ILAC Mutual Recognition Arrangement.

The ILAC decisions for the transition period for each revised standard, in the form of a General

Assembly resolution, are published on the ILAC website.

Current resolutions: None currently active

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ILAC Mutual Recognition Arrangement: Scope and Obligations

ANNEX C

Revision Table – The table provides a summary of the key changes to this document from the

previous version.

Section Amendment

Preamble and Authorship Changes to reflect addition of accreditation

of biobanks

Annex B Remove reference to expired ISO/IEC

17011 and ISO/IEC 17025 transition

periods

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