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2021 ILAC MRA Report

The 2021 ILAC MRA Report and infographic is now available to download.

ILAC and its accreditation body members invest significant effort and resources to maintain the integrity and consistency of the ILAC Mutual Recognition Arrangement (MRA), also known as the ILAC Arrangement, through a peer evaluation process.

This report provides information on the activities carried out as part of the global peer evaluation process in 2021 in order to ensure that both regulators and consumers of laboratory and inspection data, as well as users of proficiency testing programs and reference materials are able to maintain confidence in the services accredited by the signatories to the ILAC Mutual Recognition Arrangement (MRA). 

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Update from the Secretariat April 2022

World Accreditation Day (WAD)

World Accreditation Day will be celebrated on 9 June with the theme:

Accreditation: Sustainability in Economic Growth and the Environment

This theme focuses on how accreditation supports many of the United Nations Sustainable Development Goals (SDGs) including 6, 7, 8, 9, 11, 12, 13, 14, 15.

The poster for #WAD2022 is available from https://ilac.org/news-and-events/world-accreditation-day-2022/ and congratulations are extended to Punyasorn Lumjuan who created this design as part of the competition run by ILAC and IAF earlier this year.

Social media cards for the different SDGs addressed in this year’s theme are also available from the members area of the website for use by members in promoting #WAD2022.

In the near future the Joint Statement from the ILAC and IAF Chairs will also be issued as well as a brochure and video to promote the event.

Follow ILAC and IAF on Twitter for more information about accreditation supporting the implementation of the SDGs in the period leading up to WAD.

The ILAC MRA

Updating of the ILAC documents, in particular ILAC P4, P5 and R6 is progressing well as part of the implementation of ILAC Resolution GA 25.09 to extend the ILAC MRA to include the accreditation of biobanks. The activity will be included in the MRA as a Level 2 activity using, ISO 20387: Biobanking – General requirements for biobanking as the Level 3 normative document.

There are currently 104 signatories to the ILAC MRA representing 105 economies. The ILAC MRA covers recognition for accreditation in the areas of calibration (ISO/IEC 17025), testing (ISO/IEC 17025), medical testing (ISO 15189), inspection (ISO/IEC 17020), proficiency testing providers (ISO/IEC 17043) and reference material producers (ISO 17034). The list of signatories to the ILAC MRA is available from the ILAC MRA Signatory Search.

The scope of recognition of the recognised regions to the ILAC MRA is available from https://ilac.org/ilac-mra-and-signatories/recognised-regional-cooperation-bodies/.

The ILAC MRA Annual Report 2021 and associated infographic will be published next month and will be available from https://ilac.org/publications-and-resources/ilac-promotional-brochures/.

Case studies and research on the recognition of the ILAC MRA by governments and regulators are available from the Public Sector Assurance website. This website a collaborative initiative of the INetQI members is currently being updated with a significant number of new case studies collected in support of the WAD 2022 theme – Accreditation: Sustainability in Economic Growth and the Environment.

The Business Benefits website, also another successful collaboration of the InetQI partners, is a reference website designed to demonstrate the monetary value of standards, conformity assessment and accreditation for businesses.

ILAC Membership

The ILAC membership as at 7 April 2022 is:

  • 104 Full Members (signatories to the ILAC MRA) representing 105 economies;
  • 19 Associates representing 24 economies;
  • 22 Stakeholders; and
  • 6 Regional Cooperation Bodies (includes 5 Recognised Regional Cooperation Bodies)

The ILAC membership consists of 151 organisations from 129 different economies worldwide. Over 81,700 laboratories, 12,200 inspection bodies, 500 PTP and 200 RMP are accredited by the ILAC Full Members (signatories to the ILAC MRA).The latest statistics and graphs on the number of accreditation bodies, accredited laboratories, inspection bodies, PTPs and RMPs are available from the ILAC Facts & Figures page   

ILAC Meetings

The ILAC-IAF meetings including all committees and working groups continue to be held on-line.

The April 2022 mid-term meetings have been scheduled as a virtual series of meetings and registration is currently open for these meetings that will be held over the next two weeks. Some Committees and working groups that organise and manage their own on-line meetings have already met earlier this month including the Joint ILAC and IAF Executive Committees (JEC) where the key topics discussed included progress on the Single Organisation Project and future joint meetings.

The Joint IAF/ILAC annual meetings in 2022 are however scheduled to be held in person at Le Westin, Montreal, Canada from 2 – 11 November 2022.

Information on future meetings and events, including major regional meetings, can also be found in the ILAC Calendar.

ILAC Liaisons and other International Activities

ILAC carries out a number of regular liaison activities with our international partners, participating in both the routine meetings (currently on-line) that underpin these relationships as well as any relevant ad hoc events that are scheduled throughout the year. The current list of ILAC liaison activities includes:

ILAC Liaisons with ISO and ISO/CASCO Policy Committees

  • ISO-IAF-ILAC JSG (Joint Strategic Group)
  • ISO/CASCO Plenary
  • ISO/CASCO CPC (Chairman’s Policy Committee)
  • ISO/CASCO STAR (Strategic Alliance and Regulatory Group)
  • ISO/CASCO TIG (Technical Interface Group)
  • ISO TC 69/ SC6 (Application of statistical methods)
  • ISO TC 176 (Quality Management & Quality Assurance)
  • ISO TC 212 Plenary (Clinical Laboratory Testing and In-Vitro Diagnostic Systems) and WG1 (ISO 15189 revision)
  • ISO TC 272 WGs 1-5 (Forensic Sciences)
  • ISO TC 276 WG2 (Biobanking)
  • ISO TC 334 (Reference Materials – formerly ISO/REMCO)

ILAC Liaisons with ISO/CASCO Working Groups/Task Forces

  • ISO/CASCO CPC TG Future of CASCO Toolbox
  • ISO/CASCO WG 56 Revision of Guide 60 – Code of Practice
  • ISO/CASCO WG 57 Revision of ISO/IEC 17043

ILAC Liaisons with Other Organisations

  • BIPM-ILAC WG Bipartite
  • BIPM-ILAC-ISO-OIML Quadripartite
  • OIML-CS Management Committee (MC)
  • CITAC (Cooperation on International Traceability in Analytical Chemistry)
  • EUROLAB Conference
  • IEC/IECEE International Electro-technical Commission (ILAC-IAF-IEC Steering Committee)
  • INetQI International Network on Quality Infrastructure
  • JCGM Joint Committee for Guides in Metrology Plenary and WGs 1 (GUM) and 2 (VIM)
  • JCTLM Joint Committee on Traceability in Laboratory Medicine
  • ITU International Telecommunication Union
  • OECD Organisation for Economic Cooperation and Development
  • WADA World Anti-Doping Agency

Information on ILAC’s partnerships, including copies of communiqués, joint procedures, press releases and MoUs, is available from the ILAC Partnerships page.

ILAC thanks all of the ILAC liaison officers, and their organisations, who volunteer their time to assist ILAC in carrying out these activities for the benefit of all ILAC members.

ILAC Secretariat

Stephanie Sun, the ILAC Project Officer is currently on maternity leave until July 2022.

The ILAC Secretariat staff currently includes: Annette Dever, Sharon Kelly, Hannah Yeoh, Rebecca Sheehan, Rose De Rota (0.7 FTE), Joelle Nicolas (0.8 FTE) and Stephanie Sun (maternity leave July 2021- August 2022).

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Update from the Secretariat

World Accreditation Day (WAD)

World Accreditation Day was celebrated on 9 June with the theme:

“Accreditation: Supporting the Implementation of the Sustainable Development Goals (SDGs).”

This was again primarily celebrated on-line this year, with many well attended webinars held globally including the Joint IAF/ILAC event hosted by the Joint Working Group Communications Co-chairs, Brahim Houla and Veronica Ramirez, and with presentations from UNIDO and ISO CASCO.

The engagement on social media around this event with our members and accredited CABs continues to grow each year and was of a high standard.

COVID-19 Update

IAF, ILAC and ISO, under the coordination of the IAF/ILAC/ISO Joint Strategic Group (JSG), developed a survey to better understand the views of the conformity assessment (CA) community and those that rely on the results of CA, on the use of remote techniques for audit/assessment/evaluation activities. These techniques have been widely introduced in a short period of time and used extensively as a result of the pandemic.

There was an excellent response to the survey with more than 4000 participants representing the auditor/assessor/evaluator viewpoints as well as the audited/assessed/evaluated experience. The report on the outcome of the survey was released on 12 October 2021 and can be accessed from the ILAC website: Full Article and Survey Report

ISO 15189 Communiqué

The Joint IAF-ILAC-ISO Communiqué on ISO 15189 accreditation that was originally issued in 2009 to reinforce the fact that medical laboratories accredited to ISO 15189:2007 Medical laboratories – Particular requirements for quality and competence operate a recognised management system has recently been updated. The dates for the standards referenced in the Communiqué have been removed ensuring it continues to remain current as the standards are re-issued. The current editions of the standards referenced in the Communiqué are now implied. The November 2021 version of the Communiqué is available from https://ilac.org/about-ilac/partnerships/international-partners/iso/

Decision to Establish a Single International Organisation for Accreditation

The contractor, Thomas Facklam, for the IAF-ILAC Single International Organisation for Accreditation Project provided an update on this work to the ILAC General Assembly on 2 November 2021. A draft of the partial bylaws for the new organisation will be distributed to IAF and ILAC members for review and comment in the near future.

The ILAC MRA

ILAC Resolution GA 25.09 was approved at the ILAC General Assembly earlier this month endorsing the recommendation from the ILAC Arrangement Committee to extend the ILAC MRA to include the accreditation of biobanking facilities. The activity will be included in the MRA as a Level 2 activity using, ISO 20387: Biobanking – General requirements for biobanking as the Level 3 normative document. The ILAC documents applicable to the MRA will now be reviewed and updated to include this new scope to facilitate the regions applying for recognition for this activity.

There are currently 104 signatories to the ILAC MRA representing 105 economies. The ILAC MRA covers recognition for accreditation in the areas of calibration (ISO/IEC 17025), testing (ISO/IEC 17025), medical testing (ISO 15189), inspection (ISO/IEC 17020), proficiency testing providers (ISO/IEC 17043) and reference material producers (ISO 17034). The list of signatories to the ILAC MRA is available from the ILAC MRA Signatory Search.

The scope of recognition of the recognised regions to the ILAC MRA is available from https://ilac.org/ilac-mra-and-signatories/recognised-regional-cooperation-bodies/.

The ILAC MRA Annual Report 2020 has been published and is available from https://ilac.org/publications-and-resources/ilac-promotional-brochures/.

As reported at the ILAC General Assembly on 2 November 2021, all accreditation bodies that are signatories to the ILAC MRA completed the transition to the 2017 version of ISO/IEC 17011 by the November 2020 deadline.

In addition, ARAC, EA and IAAC confirmed all the accreditation bodies that are signatories to the MRA/MLAs had completed the transition to ISO/IEC 17025:2017 by the 1 June 2021 deadline. In the case of APAC, AFRAC and SADCA supporting information was provided advising of the actions taken (eg suspension or withdrawal of accreditation) by the accreditation bodies in relation to the accredited laboratories that had not completed the transition to the 2017 version of ISO/IEC 17025 by the deadline.

The ILAC AMC Chair, Jennifer Evans, in particular thanked the regional MRA/MLA Committees for their extensive commitment and work in supporting the achievement of these transition deadlines.

Case studies and research on the recognition of the ILAC MRA by governments and regulators are available from the Public Sector Assurance website. The website is a collaborative initiative of the INetQI members and there are over 330 case studies, 90 research papers and 60 supporting materials available. This material is now also searchable by UN Sustainable Development Goals (SDG).

The Business Benefits website a reference website designed to demonstrate the monetary value of standards, conformity assessment and accreditation for businesses. The website represents another successful collaboration of the INetQI partners with over 95 case studies categorised into 6 areas of value. All of the case studies identify a clear financial benefit. The site also includes more than 75 research papers.

ILAC Membership

The ILAC membership as at 18 November 2021 is:

• 104 Full Members (signatories to the ILAC MRA) representing 105 economies;
• 16 Associates representing 22 economies;
• 4 Affiliates representing 8 economies;
• 22 Stakeholders; and
• 6 Regional Cooperation Bodies (includes 5 Recognised Regional Cooperation Bodies).

The ILAC membership consists of 152 organisations from 128 different economies worldwide. Over 81,700 laboratories, 12,200 inspection bodies, 500 PTP and 200 RMP are accredited by the ILAC Full Members (signatories to the ILAC MRA).The latest statistics and graphs on the number of accreditation bodies, accredited laboratories, inspection bodies, PTPs and RMPs are available from the ILAC Facts & Figures page.

ILAC Meetings

The ILAC-IAF meetings including all committees and working groups continue to be held on-line.

The 25th ILAC General Assembly was held virtually for the second year running on 2 November 2021. The Adopted Resolutions are available to download from the ILAC website.

The April 2022 mid-term meetings will also been scheduled and conducted as a virtual series of meetings.

The Joint IAF/ILAC annual meetings in 2022 are scheduled to be held in person at Le Westin, Montreal, Canada from 2 – 11 November 2022.

Information on future meetings and events, including major regional meetings, can also be found in the ILAC Calendar.

ILAC Liaisons and other International Activities

ILAC carries out a number of regular liaison activities with our international partners, participating in both the routine meetings (currently on-line) that underpin these relationships as well as any relevant ad hoc events that are scheduled throughout the year. The current list of ILAC liaison activities includes:

ILAC Liaisons with ISO and ISO/CASCO Policy Committees

• ISO-IAF-ILAC JSG (Joint Strategic Group)
• ISO/CASCO Plenary
• ISO/CASCO CPC (Chairman’s Policy Committee)
• ISO/CASCO STAR (Strategic Alliance and Regulatory Group)
• ISO/CASCO TIG (Technical Interface Group)
• ISO TC 69/ SC6 (Application of statistical methods)
• ISO TC 176 (Quality Management & Quality Assurance)
• ISO TC 212 Plenary (Clinical Laboratory Testing and In-Vitro Diagnostic Systems) and WG1 (ISO 15189 revision)
• ISO TC 272 WGs 1-5 (Forensic Sciences)
• ISO TC 276 WG2 (Biobanking)
• ISO TC 334 (Reference Materials – formerly ISO/REMCO)

ILAC Liaisons with ISO/CASCO Working Groups/Task Forces

• ISO/CASCO CPC TG Future of CASCO Toolbox
• ISO/CASCO WG 56 Revision of Guide 60 – Code of Practice
• ISO/CASCO WG 57 Revision of ISO/IEC 17043

ILAC Liaisons with Other Organisations

• BIPM-ILAC WG Bipartite
• BIPM-ILAC-ISO-OIML Quadripartite
• OIML-CS Management Committee (MC)
• CITAC (Cooperation on International Traceability in Analytical Chemistry)
• EUROLAB Conference
• IEC/IECEE International Electro-technical Commission (ILAC-IAF-IEC Steering Committee)
• INetQI International Network on Quality Infrastructure
• JCGM Joint Committee for Guides in Metrology Plenary and WGs 1 (GUM) and 2 (VIM)
• JCTLM Joint Committee on Traceability in Laboratory Medicine
• ITU International Telecommunication Union
• OECD Organisation for Economic Cooperation and Development
• WADA World Anti-Doping Agency

Information on ILAC’s partnerships, including copies of communiqués, joint procedures, press releases and MoUs, is available from the ILAC Partnerships page.

ILAC thanks all of the ILAC liaison officers, and their organisations, who volunteer their time to assist ILAC in carrying out these activities for the benefit of all ILAC members.

ILAC Secretariat

Stephanie Sun, the ILAC Project Officer commenced maternity leave in July 2021 for 12 months.

Vanessa Oconer Muhi, ILAC Quality Officer, left the Secretariat to take up a permanent position at the beginning of July 2021.

The ILAC Secretariat staff currently includes: Annette Dever, Sharon Kelly, Hannah Yeoh, Rebecca Sheehan, Rose De Rota (0.7 FTE), Joelle Nicolas (0.8 FTE) and Stephanie Sun (maternity leave July 2021- August 2022).

Documents and Brochures

Publications available since April 2021 include:
Statement 03/2021: Replacement of Assessments During the COVID-19 Pandemic

ILAC G7:04/2021 Accreditation Requirements and Operating Criteria for Horseracing Laboratories

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