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Third Accreditation Matters Episode Released

IAF and ILAC have released the third episode of Accreditation Matters, our podcast featuring discussions with international experts on important matters to the international quality infrastructure community and the way that accreditation supports regulators, global trade and consumers.

In this episode, IAF CABAC Chair Marcus Long (IIOC) interviews IAF UAC Vice-Chair Sheronda Jeffries (TIA QuEST Forum) and Professor Pavel Castka (University of Canterbury) about the role of technology in delivering trustworthy, effective, and valuable accredited conformity assessment. They discuss topics including the impact of COVID-19 on the conformity assessment community, views on digitalization and remote audits and assessments, new technologies, and the opportunities and challenges of digital transformation.
 
Listen to the episode now on Spotify, Apple Podcast, Google Podcasts or Amazon Music, or watch it on YouTube.

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ISO 15189:2022 for medical labs published

We are pleased to advise that ISO 15189:2022 Medical Laboratories – Requirements for quality and competence has now been published.

Further a resolution was endorsed at the ILAC General Assembly held last month to allow a 3-year implementation period from the date of publication of this revised standard (ie now December 2025) as shown below:

 

ILAC Resolution GA 26.08

As the revised version of ISO 15189 is scheduled for publication in 2022 or early 2023, the General Assembly endorses the recommendation of the AIC that a transition period of 3 years from the date of publication be adopted. 

Noting that the requirements for Point of Care Testing (POCT) contained in ISO 22870:2016 have been incorporated into the revised ISO 15189, ISO 22870:2016 in conjunction with ISO15189:2012 will still be recognised as a Level 4 standard for POCT for the duration of the transition period. 

At the end of the transition period, accreditation of a medical laboratory to ISO 15189:2012 and accreditation of POCT to ISO 22870:2016 in conjunction with ISO15189:2012 will not be recognised under the ILAC Arrangement.

 

The implementation of this transition period for ISO 15189:2022 by the signatories to the ILAC MRA for the accreditation of medical laboratories will be monitored by the ILAC AMC to ensure the deadline is achieved. The process used by the AMC to monitor this implementation of the revised standard will be similar to that used during the implementation of ISO/IEC 17025:2017

 

We would also like to take this opportunity to thank Erik Oehlenschlaeger, ILAC AIC Chair, the members of the AIC ISO 15189 working group and our liaison officers to the ISO WG responsible for this standard for their contributions on behalf of ILAC to the revision of this important standard for our accreditation body members and their accredited medical laboratories.

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New Episode of Accreditation Matters

IAF and ILAC have released the second episode of our new podcast, Accreditation Matters, which features discussions with international experts on important matters to the international quality infrastructure community and the way that accreditation supports regulators, global trade and consumers.

In this episode, Rebecca Sheehan of the ILAC Secretariat interviews IAF Chair Emanuele Riva (Accredia) and AFRAC Chair Ron Josias (SANAS) on the role of accreditation and accredited conformity assessment in supporting environmental, social and governance (ESG) declarations. Mr. Riva and Mr. Josias discuss topics including the importance of ESG criteria, how accreditation can combat greenwashing and support human health, international collaboration in this area, and the value of IAF CertSearch.

Listen to the episode now on Spotify, Apple Podcast, Google Podcasts or Amazon Music, or watch it on YouTube.

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Extension of Recognition of AFRAC MLA!

Further to the announcement earlier this month regarding the continuation of the recognition for the African Accreditation Cooperation (AFRAC) as a recognised regional cooperation body of ILAC, we are now pleased to also announce the implementation of the extension of the recognition of the AFRAC MLA to the ILAC MRA to include the accreditation of RMP and PTP as noted in the Arrangement Council decision below. The effective date for these extensions is 8 November 2022.

“The ILAC AMC recommends that recognition of the AFRAC MLA to the ILAC MRA should be continued for calibration and testing (ISO/IEC 17025) and medical testing (ISO 15189) laboratory and inspection body (ISO/IEC 17020) accreditation schemes.

In addition, it is recommended that the recognition of the AFRAC MLA to the ILAC MRA should be extended to include the accreditation of RMP (ISO 17034) and PTP (ISO/IEC 17043) however the effective date for the implementation of these extensions will be deferred until the AFRAC MLA has been extended to include the accreditation of PTP and RMP.

It is recommended that the next re-evaluation of AFRAC be scheduled for 4 years and therefore should commence no later than February 2025.”            

Information on the recognised regions including AFRAC to the ILAC MRA is available from https://ilac.org/ilac-mra-and-signatories/recognised-regional-cooperation-bodies/

We look forward to continuing to work with our colleagues from AFRAC.

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2022 ILAC GA Resolutions

The virtual meeting of the 26th ILAC General Assembly was held on the 15th of November 2022.

The adopted resolutions from the ILAC 2022 General Assembly are now available here.

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AFRAC recognition to the ILAC MRA continued

As a result of the recent ILAC Arrangement Council ballot, the continuation of the recognition for the African Accreditation Cooperation (AFRAC) as a recognised regional cooperation body of ILAC has been confirmed. The endorsed AMC recommendation including the extensions for RMP and PTP is shown below:

The ILAC AMC recommends that recognition of the AFRAC MLA to the ILAC MRA should be continued for calibration and testing (ISO/IEC 17025) and medical testing (ISO 15189) laboratory and inspection body (ISO/IEC 17020) accreditation schemes.

In addition, it is recommended that the recognition of the AFRAC MLA to the ILAC MRA should be extended to include the accreditation of RMP (ISO 17034) and PTP (ISO/IEC 17043) however the effective date for the implementation of these extensions will be deferred until the AFRAC MLA has been extended to include the accreditation of PTP and RMP.

It is recommended that the next re-evaluation of AFRAC be scheduled for 4 years and therefore should commence no later than February 2025.”             

Information on the recognised regions including AFRAC to the ILAC MRA is available from https://ilac.org/ilac-mra-and-signatories/recognised-regional-cooperation-bodies/

We look forward to continuing to work with our colleagues from AFRAC.

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A2LA receives APAC recognition for Biobanking

Biobanks play an integral role in the life science industries, particularly in medical research and development. When Dr. Marta Castelhano, Associate Research Professor from Cornell University and Director of the Cornell Veterinary Biobank (CVB), approached A2LA with a request to create a program for the newly published ISO 20387:2018 General Requirements for Biobanking, we were happy to develop a program for Biobanking organizations. This initial effort was led by Accreditation Officer Jason Poore, now positioned as A2LA’s Contracts Manager, and later transitioned to Cory Arant, Program Manager for the Biological field in the Life Sciences department.  A2LA created the initial program to facilitate the first ever ISO 20387 Biobank assessment for Cornell University. In order to be considered for ISO 20387:2018 accreditation, the biobank must acquire and store biological material and/or the associated data, as well as at least one other activity to include collection, preparation, preservation, testing, analysis, and distribution. Not only did CVB need to document its processes and maintain strict record retention according to the requirements of ISO 20387:2018, but they also had to meet the applicable requirements imposed by A2LA. True to A2LA’s vision of ‘Accreditation Accepted Everywhere’ the program must include applicable requirements set forth by ISO/IEC 17011:2017 and the International Laboratory Accreditation Cooperation (ILAC).

In April 2019, CVB successfully received their accreditation demonstrating competence in their processes and activities in the field of Biobanking becoming the first biobank in the world to receive accreditation to ISO 20387:2018 – see below CVB press release:

https://news.cornell.edu/stories/2019/05/veterinary-biobank-first-accredited-under-new-standard

Since that first assessment, led by Jason Poore and long-time biological assessor Tina Buffington, A2LA has performed 8 assessments resulting in 5 Biobanking organizations gaining accreditation. This is a giant step that our accredited Biobanks took towards ensuring the quality of their biological material is at the highest level for research and development purposes.

A2LA underwent our quadrennial Asia Pacific Accreditation Cooperation (APAC) re-evaluation in June 2022; the first evaluation to include ISO 20387 Biobanking under the MRA.  The APAC MRA Council rendered their affirmative recognition decision on October 15, 2022, marking A2LA as the first Accreditation Body in the world to achieve regional Mutual Recognition for our ISO 20387 Biobanking program.  

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Secretariat Update October 2022

World Accreditation Day (WAD)

World Accreditation Day 2022 was successfully celebrated on 9 June with the theme:

Accreditation: Sustainability in Economic Growth and the Environment

Information and materials associated with WAD are all available from the ILAC website: https://ilac.org/news-and-events/

The ILAC MRA

The ILAC MRA Annual Report 2021 and associated infographic was published in June 2022 and is available from https://ilac.org/publications-and-resources/ilac-promotional-brochures/.

Work to extend the ILAC MRA to include the accreditation of biobanks continues following the adoption of the following resolution during the 25th ILAC General Assembly in 2022: ILAC Resolution GA 25.09 The General Assembly endorses the recommendation of the ARC to extend the ILAC Mutual Recognition Arrangement (MRA) to include accreditation of biobanking as a Level 2 activity, to the criteria specified in the Level 3 normative document, ISO 20387. ILAC will therefore accept applications for recognition as soon as the documents within ILAC applicable to the MRA are updated to cover this new scope.

The relevant documents, ILAC P4, P5 and R6 have now been revised and published on the ILAC website. ILAC is therefore now able to accept applications from the regional groups for evaluation to extend their scope of recognition to the ILAC MRA to include this new activity.

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/.

There are currently 108 signatories to the ILAC MRA representing 116 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.

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 to view.

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 20 September 2022 is:

  • 108 Full Members (signatories to the ILAC MRA) representing 116 economies;
  • 18 Associates representing 19 economies;
  • 22 Stakeholders;
  • 6 Regional Cooperation Bodies (includes 5 Recognised Regional Cooperation Bodies).

The ILAC membership consists of 154 organisations from 129 different economies worldwide. Over 85,000 laboratories, 13,000 inspection bodies, 600 PTP and 250 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.

Decision to Establish a Single International Organisation for Accreditation

The work to establish a Single International Accreditation Organisation in accordance with the 2019 JGA Frankfurt Resolutions continues with the contractor, Dr.-Ing. Thomas Facklam continuing to work closely with the Joint Steering Committee established to oversee this project.

Most recently an Extraordinary meeting of the ILAC GA was requested by some members and held on 15 September 2022. The meeting focussed on specific topics associated with the establishment of the new single international organisation for accreditation. An update on the project was provided by the ILAC Chair and presentations on the specific topics being considered were provided by each of the Regional Cooperation Body members as well as the ILAC LC Chair representing the ILAC Stakeholder members. The meeting provided a platform for contributions from all ILAC members and IAF invited observers, with 29 in total taking the opportunity to present their views on the topics being discussed, in addition to the written comments provided via the meeting chat function.

An IAF/ILAC Joint General Assembly is scheduled for 10 November 2022, where the one organisation project will again be the focus for discussion.

ILAC Meetings

All ILAC Committees, including the Executive Committee and the Joint IAF MLA and ILAC MRA Management (JMC), Joint Marketing and Communications and Joint Development Support Committees have held virtual meetings in 2022.

The IAF/ILAC mid-term meetings were again also held virtually in April this year and included meetings of the ILAC AIC and Inspection Committees. The online platform, registration process and management of these meetings was provided by Say Something Communications.

The Joint IAF/ILAC annual meetings for 2022 that were scheduled to be held as hybrid meetings with the in-person attendance at Le Westin, Montreal, Canada from 2 – 11 November 2022 will now be held as a series of virtual meetings. The schedule and registration information for these meetings have been distributed and registration is open.

In addition to the meetings noted above all ILAC Committees, Working Groups and Task Forces are continuing to progress the items on their work plans via a combination of email and remote meetings.

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

ILAC Liaisons and other International Activities

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

A joint CIPM-ILAC Webinar titled: Digital Transformation in the context of Accreditation was held on 30 June 2022. It was aimed at accreditation body and laboratory staff and addressed topics including: the SI digital framework, digital reporting in an accreditation body, opportunities and challenges with the introduction of digital calibration certificates and a Q&A session. The video recording and related materials from this webinar are now available from the ILAC – BIPM partnership page on the website.

The International Telecommunications Union (ITU), the International Accreditation Forum (IAF) and ILAC have reviewed and re-signed the Memorandum of Understanding (MoU) in
August this year. The re-signing of the ITU-IAF-ILAC MoU continues to support and strengthen the three organizations’ commitment to cooperation and collaboration and the ongoing development of ITU-T’s Conformity and Interoperability (C&I) programme.

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 returned from maternity leave on 1 August 2022 on a part-time basis.

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

Documents and Brochures

Publications available since April 2022 include:

ILAC-P4:06/2022 ILAC Mutual Recognition Arrangement: Policy and Management

ILAC-P5:06/2022 ILAC Mutual Recognition Arrangement: Scope and Obligations

ILAC-R6:06/2022 Structure of the ILAC Mutual Recognition Agreement and Procedure for Expansion of the Scope of the ILAC Arrangement

ILAC-G19:06/2022 Modules in a Forensic Science Process

Follow @ILAC_Official on Twitter to receive the latest ILAC news, including information on meetings, events, liaison activities and new publications.

The April 2022 edition of ILAC News has been published and is available from https://ilac.org/latest_ilac_news/.

Subscribe to the latest news to receive updates from ILAC members and liaisons.

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ISTA Seed Symposium 2022

Seed quality, health and identity are of paramount importance for the global economy and the environment and key for global food security. Therefore, the International Seed Testing Association (ISTA) is holding this year’s seed symposium under the theme ‘Quality Seed for Sustainable Agriculture’ in Athens, Greece from 02-04 November.

To discuss most aspects of seed quality, the symposium brings together seed analysts, technologists, researchers, and managers from universities, research institutes, the government, and the seed trade. It provides a forum for discussion of the latest advances in seed science and technology, as well as an opportunity to exchange ideas and information

The 5 symposium sessions will each have a notable lead speaker, and are composed of presentations, poster sessions, and discussions – all presenting unique networking opportunities among others.

The detailed programme of the symposium, together with accommodation and venue information is available on the ISTA website and may be accessed from this link.

Registration is still open so please click here to take part of the upcoming ISTA Seed Symposium.

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Progress on the One Organisation Project

On the 29th October 2019 the IAF-ILAC Joint General Assembly (JGA) passed a resolution to establish a single organisation for accreditation based on a survey of Members. This allows for more effective and efficient communication and services as the two organisations already work closely to ensure consistent and complementary services. 

To support the One Organization Project a Steering Committee (SC) was established which executes the project with the support from a contractor reporting to the IAF/ILAC Joint Executive Committee (JEC). This article provides an update on the work to date.

 

General outline of the new organization

It was confirmed that the new international organization for accreditation would be a worldwide association of accreditation bodies and stakeholder organisations with an interest in the accreditation of conformity assessment bodies such as testing and calibration laboratories, inspection bodies, proficiency testing providers, reference material producers, biobanks, certification bodies for management systems, persons, products, processes and services, verification and validation bodies, with a membership consisting of accreditation bodies and stakeholder organisations throughout the world.

 

Articles of association

 The draft Articles of Association (AoA) have been through several rounds of review and the next stage will be to further develop these during the JEC meeting on the 8th November 2022. Progress made at this meeting will be reported back to Members at the JGA. Issues surrounding voting rights will also be considered following Member feedback.

 

Registration

The SC has reviewed options for the registration of the new body, taking into account political climate, costs, and administrative hurdles, New Zealand is currently being considered and appears to be the best option.

 

Secretariat

Under the current timelines the secretariat services needed to manage and operate the single organization will be defined and a tender for the new secretariat will be established by the end of 2022.

 

Next steps of the One Organization Project

08.11.2022 JEC meeting – discussion on the next steps in this process and confirming proposals for presentation at the November meeting of the IAF/ILAC JGA.
10.11.2022 JGA – information of the status of the project and the proposals from the JEC on how to proceed.
TBD IAF/ILAC Joint SC meeting to implement the agreed on the next steps in the One Organization Project.

 

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