The US Food and Drug Administration (FDA) is amending its regulations under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to establish a program (LAAF) for the testing of food in certain circumstances by laboratories accredited by ILAC MRA signatories. This program will help FDA improve the safety of the U.S. food supply and protect U.S. consumers by ensuring certain food testing of importance to public health is conducted subject to appropriate oversight and in accordance with appropriate model standards to produce reliable and valid test results.
This program is relevant to accreditation bodies seeking recognition to accredit laboratories under this FDA rule, as well as laboratories seeking
accreditation to conduct food testing covered by the rule. The rule is effective 1 February 2022. Additional information on this rule as well as a list of FAQs is available from https://www.fda.gov/food/food-safety-modernization-act-fsma/fsma-final-rule-laboratory-accreditation-analyses-foods-laaf
The signatory status of Jordan Accreditation & Standardization Systems – Accreditation Unit (JAS-AU), Jordan, to the ILAC MRA has been extended to include Inspection using ISO/IEC 17020.
The full list of signatories to the ILAC MRA is available from https://ilac.org/signatory-search/ .
ILAC-G18:12/2021 – Guideline for describing Scopes of Accreditation has been published and is now available from https://ilac.org/publications-and-resources/ilac-guidance-series/
This version is a major revision of ILAC-G18:04/2010 as a result of the publication of ISO/IEC 17011:2017 as well as an extension of the scope of the document to include proficiency testing providers and reference material producers.
Trinidad & Tobago Bureau of Standards (TTBS), Trinidad & Tobago West Indies, is welcomed as an Associate Member of ILAC. TTBS has been an Affiliate member since 1998.
We welcome TTBS as an Associate Member and look forward to continuing working with our TTBS colleagues.
The latest version of ILAC-R1:12/2021 Management of ILAC Documents has been published and is available from https://ilac.org/publications-and-resources/ilac-rules-series/
This publication is a revision of ILAC R1:03/2018 to take into consideration the revised Articles of Association and Bylaws published in November 2019 as they relate to the comment and voting processes for the development, revision and publication of ILAC documents. In addition, out of date references and minor editorials have also been addressed in this latest version.
The Ghana National Accreditation Service (GhaNAS), Ghana, is welcomed as an Associate Member of ILAC. GhaNAS has been an Affiliate member since 3 April 2019.
We welcome GhaNAS as an Associate Member and look forward to continuing working with our GhaNAS colleagues.
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.
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.
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.
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.
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
A new version of the BIPM key comparison database, the KCDB 2.0, was launched in October 2019. This followed 20 years continuous and efficient operation of the original KCDB. The new version provides a web-based user platform, which allows CMC data to be drafted and reviewed while being directly linked to the database.
The introduction of the KCDB 2.0 has led to an improvement in the quality management of data and a demonstrable reduction in the delay between submission to publication of internationally recognized calibration and measurement capabilities (CMCs). On average, the delay has been reduced by a factor of 2. The KCDB 2.0 includes enhanced functionality to allow the generation of numerical data on the CMCs and comparisons.
The growing issue of digitalization and machine readability is a hot topic with far-reaching consequences, which is being debated within many areas, including metrology. Industry and other stakeholders are increasingly requesting support for digital calibration certificates. In response to this requirement, the open access search facility for CMCs has received a significant enhancement with the introduction of an API (Application Programming Interface) that can be used to program CMC queries. The API KCDB can simultaneously query the same database that is available via the KCDB web to generate machine-readable CMC data. The API KCDB may be integrated into web applications, for example to adapt the service to languages other than English.
The API KCDB software represents the latest in the BIPM’s ongoing work to ensure that the KCDB remains at the forefront of the future digitalization needs of the metrology community. It is a possible precursor to the introduction of digital CMCs and ultimately for digital calibration certificates. The API is available via the KCDB website and an introduction video has also been made available: https://www.youtube.com/watch?v=lDHh_MC2p6s
2021 has been a fruitful year for ISO’s Committee on conformity assessment (CASCO) as great progress was made on the development of its five-year strategic directions for the period 2022-2026. In parallel, CASCO is reviewing the structure of the committee to ensure that it will be in a position to fulfil its forthcoming objectives.
The IAF-ILAC-ISO Joint Strategic Group (JSG) is a forum established pursuant to the Memorandum of Understanding signed between ISO, the International Accreditation Forum (IAF) and the International Laboratory Accreditation Cooperation (ILAC) to address matters of common interest to the three organizations, including matters of conformity assessment policy and practice as they relate to accreditation. The JSG is about to complete the revision of its terms of reference, which define all aspects of how it will carry out its mandate going forward.
In January 2021, the CASCO Strategic Alliance and Regulatory Group (STAR) agreed to focus its engagement efforts on sustainability issues, with a marked emphasis on the circular economy. STAR members felt the timing was right since sustainable solutions are needed to ensure full recovery from the COVID-19 crisis, and the circular economy is gaining traction in many countries. As a starting point, a task group has set to collect and examine existing literature covering concepts and trends of the circular economy, and its impact on the United Nations Sustainable Development Goals. It also gathered examples of current conformity assessment schemes as well as concrete private or governmental initiatives supporting the circular economy in different countries. With this preliminary phase over, the STAR will continue to work on an online tool or brochure that will offer guidance, borne out by practical examples, of how to approach the circular economy from a conformity assessment perspective.
On the technical side, CASCO has continued to work remotely, with six working groups active in the revision or development of conformity assessment standards. As such, it has recently published a revised version of one of its most prominent standards, ISO/IEC 17030, that provides general requirements for third-party marks of conformity, including their issue and use. It is also in process of revising ISO/IEC 17043, which specifies requirements for the competence of proficiency testing providers. The second Committee Draft is currently being balloted by CASCO and IEC members. Lastly, the revision of ISO/IEC Guide 60, Conformity assessment – Code of good practice, has now reached Draft International Standard (DIS) stage. The DIS, which was approved by ISO and IEC members, will be published as ISO/IEC 17060, acquiring full status as an International Standard.
Meanwhile, CASCO continues to manage the request clarification process for all requests received by the CASCO Secretariat pertaining to CASCO-developed standards. These deliverables are all developed in conjunction with the International Electrotechnical Commission (IEC). A total of 5 requests had been received by the end of September.