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The first Italian research biobank compliant with UNI ISO 20387 has been accredited

The Multi-specialistic Biobank of the Pisan University Hospital has obtained accreditation in the biobanking of biological material of human origin. An important milestone, the result of international work and institutional dialogue.


A research biobank is a facility that collects, stores and manages biological material and related clinical data in an organized manner for research purposes. Biological material is an essential asset for the progress of biotechnology, an emerging sector on a world scale, which, according to OECD estimates, will have a huge weight on the world economy in 2030 and will account for 2.7% of global GDP overall.

Research biobanks have a wide impact and those who use deposited materials require guarantees regarding the collection, transport, storage, traceability and distribution of these materials. For the progress of research, it is therefore essential that the biological materials deposited are of quality, and that they are managed by the biobanks in order to ensure the reproducibility and comparability of the research results, through standard processes and procedures.

These needs are met by the accreditation of biobanks according to UNI ISO 20387:2019 “Biotechnologies – “Biobanking” – General requirements for biobanking”, specifying the general requirements of competence, impartiality and consistent functioning of the structures. The standard defines a broad framework of reference shared internationally for the collection, storage and subsequent use of samples, and represents the reference for requesting and obtaining accreditation.

On 14 July, the first Italian Biobank – the Multi-speciality Biobank of the Pisan University Hospital – obtained accreditation in compliance with UNI ISO 20387. The assessment process involved an assessment team with expertise in both biobanking and biological material of human origin, in the field of quality management systems, IT and information security, privacy and GDPR. The assessment was carried out on a documentary level and through on-site verification. It is the first Italian biobank to obtain this very important recognition.

The accreditation scheme and related regulations were developed by the Calibration Laboratories Department of Accredia, in collaboration with the National Institute of Health in Italy (ISS – Istituto Superiore di Sanità) and the Testing Laboratories Department of Accredia. The support of a Technical Consultation Table specifically set up and composed of the main institutions involved is also fundamental: Ministry of Health, Ministry of Agricultural, Food and Forestry Policies, National Institute of Health in Italy, Association of Zooprophylactic Institutes, Council for Research in Agriculture and analysis of the agricultural economy, BBMRI – Italy, National Institute of Metrological Research, JOINT RESEARCH UNIT MIRRI-IT, National Order of Biologists, RIBES.

A result achieved thanks to the collaboration between Accredia and the Ministry of Health with the launch of a Pilot Project which in 2021 involved three Biobanks belonging to three Scientific Institutes for Research, Hospitalization and Healthcare (IRCSS) in the preliminary assessments in compliance with the standard UNI ISO 20387.

Accreditation provides a clear and reliable index of the capabilities and adequacy of the structure in terms of competence, impartiality and consistent functioning, in line with the international standard. Furthermore, the assessment process preparatory to the issue of the accreditation certificate provides valuable information to support the Biobank in the fundamental process of simplifying the procedures, favouring a potential saving of time and money.

As for the results, accreditation increases confidence in the production of the biobank and ensures that interested parties comply with the crucial requirements, contributing to the progress of scientific research in the sector.

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Introduction in China of proficiency testing for lithium batteries in accordance with UN 38.3 and relevant proposal

Chinese delegation introduced the proficiency testing project for lithium battery UN38.3 inspection organized by China National Accreditation Service for Conformity Assessment (CNAS) in the form of information document at the 60th United Nation Committee of Experts on the Transport of Dangerous Goods on June 28, 2022. A proposal was also made on further clarification on some unclear description of test requirements in relevant United Nation standard.

Representatives from many countries agreed with the content of the document, and expressed their willingness to establish a dialogue mechanism with the Chinese side and relevant laboratories to jointly study and solve the problems existing in the current technical standard.

Download the document here.

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Cofrac: Accredited inspection of social and medico-social establishments and services

The Cofrac has opened the accreditation for the inspection bodies in charge of social and medico-social establishments and services (SMSES) assessment.

In France more than 45,000 SMSES care for old people, disabled persons or persons with specifics difficulties. A reform provides the French High Authority of Health (HAS) the responsibility to create a new assessment plan and review the recognition method for the bodies in charge of it. The aim of this reform thanks to accreditation is to measure the quality of the services delivered to people by the SMSES.

The assessment plan relies on the decree nr 2022-742 which makes accreditation mandatory for this activity and presents this assessment process set by the HAS.

On the 16th of May 2022, the Cofrac opened the accreditation for inspection bodies according to the ISO/IEC 17020 standard. To start this reform, the aforementioned decree allows the inspection bodies to assess the SMSES as soon as they get involved in an accreditation process. In particular, the Cofrac has developed a plan in two parts:

  1. The first part is the admissibility (administrative and operational) of the request. At the end of this step, the Cofrac delivers or not a positive operational admissibility. This notification allows the inspection body, to register on the Synaé platform and begin to assess the SMSES while awaiting its accreditation.
  2. The last part is the assessment by Cofrac. It intervenes as soon as the inspection body has assessed at least one SMESS according to the new standard. This assessment takes place on the inspection body site and also includes the observation of an assessment inside an SMSES. If the review of the report submitted by the Cofrac teams’ assessors comes to a favourable decision, the accreditation is granted.

 The inspection body has a maximum period of 18 months from the date of its positive operational admissibility to obtain its accreditation.

The accreditation scheme is fully operational. A significant number of inspection bodies applying for accreditation have already entered the accreditation process.

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First assessment of the Environmental Analysis Laboratory of the Polytechnic Faculty of the University of Lubumbashi

The Environmental Analysis Laboratory (LAE) is the first university laboratory in the Democratic Republic of Congo to be accredited by SADCAS according to the requirements of the ISO/CEI 17025:2017 standard since September 2021 (accreditation number: TEST- 50063). Its field of activity concerns environmental analyses: air, water, soil and waste.

The LAE’s mission is to provide scientific expertise and develop knowledge to know the quality of the environment in order to develop society in a sustainable way. As such, it offers in the field of the environment, management and sustainable exploitation of natural resources: training, research, professional supervision and expertise for the benefit of industrialists.

The first assessment of the LAE by SADCAS took place on Monday, September 12, 2022 in face-to-face. The LAE thus becomes the first SADC laboratory to undergo a post-COVID assessment by SADCAS.

a) Opening meeting with all LAE staff;

b) Working session: assessment of the LAE management system;

c) Working session: technical evaluation.

All chapters (management and technical) of the system have been assessed against the requirements of the international standard ISO/IEC 17025:2017 and the additional requirements of SADCAS/ILAC/IAF.

The vertical evaluation and the witnessing were the subject of the technical evaluation. At the end, two new technical signatories have been successfully assessed and their approvals are in progress. A few discrepancies were noted by the evaluation team and a corrective action plan was submitted for approval.

In view of the low number of non-conformities encountered, the LAE hopes to maintain its accreditation.

The head of the LAE, Prof. Arthur KANIKI particularly thanks the Rector of the University of Lubumbashi, Prof. Gilbert KISHIBA for his support as well as Dean Jean-Marie KANDA for his support. He commends the commitment of all his staff. He warmly thanks the CEO of ASCOLAB (NLA/DRC), Mr. Victor KANAMA Viki Mbuya for his coaching.

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The Re-Evaluation of MAURITAS by the African Accreditation Cooperation (AFRAC) and the Southern African Development Community Cooperation in Accreditation (SADCA) on behalf of the International Laboratory Accreditation Cooperation (ILAC)  International Accreditation Forum (IAF) took place on 13 to 17 June 2022. The aim of the Re-Evaluation was to evaluate the continued international recognition of MAURITAS accreditation for Testing (ISO/IEC 17025), Calibration (ISO/IEC 17025) and Management System Certification (17021) in the sub-scopes Quality Management System (QMS – ISO 9001) and Food Safety Management System (FSMS – ISO 22000).

The composition of the Evaluation Team was as follows:




Position in Evaluation Team


Ms. Susan Munyiri-Ochieng

Kenya Accreditation Service (KENAS)

Team Leader


Mr. Shadrack Phophi

South African National Accreditation System (SANAS)

Deputy Team Leader and Team Member – Testing


Mr. Neville Tayler

South African National Accreditation System (SANAS)

Team Member – Calibration


Mr. Moslem Barrack

Tunisian Accreditation Council (TUNAC)

Team Member – Certification (QMS & FSMS)


Mr. Sam Thema

South African National Accreditation System (SANAS)

Trainee Team Member – Calibration


Mrs. Felista Nyakoe

Kenya Accreditation Service (KENAS)

Trainee Team Member – Certification (QMS & FSMS)


Mr. Emanuele Riva

L’Ente Italiano di Accreditamento (ACCREDIA)

ILAC/IAF Observer – Certification


Mrs. Dana Leaman

National Voluntary Laboratory Accreditation Program (NVLAP)

ILAC/IAF Observer – Calibration


Mr. Rob Miller

American Association for Laboratory Accreditation (A2LA)

ILAC/IAF Observer – Testing

MAURITAS successfully cleared all the findings raised by the Evaluation Team and consequently its signatory status within AFRAC was approved during the AFRAC General Assembly on 30 September 2022 in Cairo, Egypt.

Mr. R.N. Gopee (Director, MAURITAS) and Mr. R. Miller (ILAC/IAF Observer – Testing)

Mr. S. Phophi (Deputy Team Leader and Team Member – Testing) and Mr. M. Koolwont (Accreditation Manager, MAURITAS)

Mrs. F. Nyakoe (Trainee Team Member – Certification for QMS & FSMS), Mr. M. Barrack (Team Member – Certification for QMS & FSMS) and Mrs. C. Matadeen-Domun (Assistant Accreditation Manager – MAURITAS)

Mr. S. Thema (Trainee Team Member – Calibration), Mr. N. Tayler (Team Member – Calibration) and Mrs. Y. Jafajul (Ag. Assistant Accreditation Manager – MAURITAS)

Closing meeting of the MAURITAS Re-Evaluation

The Evaluation Team members with staff of MAURITAS

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World Accreditation Day 2023 Poster Contest

Each year on 09 June, IAF and ILAC celebrate World Accreditation Day (WAD) with our members, partners, stakeholders and other organizations in the field of conformity assessment. We’re excited to announce the theme for WAD 2023 as Accreditation: Supporting the Future of Global Trade.

This theme will showcase how accreditation and accredited conformity assessment activities support the ongoing global supply chain restructuring that continues to be a source of trade normalization as firms seek new markets and investment opportunities to build resilient and flexible supply chains. This is likely to reinforce long-term growth in multilateral and bilateral trade relationships and augment the value of the ILAC/IAF mutual recognition arrangements in promoting greater supply chain efficiency and resilience.

The theme encompasses a wide variety of Sustainable Development Goals (SDGs), including SDG 1: No Poverty; SDG 2: Zero Hunger; SDG 3: Good Health and Well-Being; SDG 5: Gender Equality; SDG 8: Decent Work and Economic Growth; SDG 9: Industry, Innovation and Infrastructure; SDG 10: Reduced Inequalities; SDG 14: Life Below Water; and SDG 17: Partnerships for the Goals. Case studies and research on benefits that accreditation can provide in support of the SDGs are available on the Public Sector Assurance and Business Benefits websites.

The IAF and ILAC poster contest to develop the official WAD 2023 poster will commence 26 October 2022, with a submission deadline of 23:59 UTC on 22 November 2022. All interested parties are welcome to explore our theme of Accreditation: Supporting the Future of Global Trade with up to three entries. The contest winner will receive USD 1,500, while the two runners-up will receive USD 500 each.

The contest rules, including instructions for how to submit entries, are available here. Read about last year’s winner here and runners-up here.

We look forward to receiving your submissions!

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2022 ISO Annual Meeting Virtual Session

Standards and conformity assessment provide the tools to deliver trust and confidence about the environment in which we live. But what happens when this environment changes? Accelerated by the COVID-19 pandemic, digitalization has fundamentally altered the way we live, work and relate to each other. Conformity assessment actors have had to develop alternative ways of working based on AI, machine learning, remote auditing, constant data exchange and much more.

For this year’s ISO’s Annual Meeting being held from 19-23 September 2022, IAF, ILAC and ISO have collaborated to organize the virtual session ‘Has Covid launched the digital transformation of conformity assessment?’. The session will be moderated by Marcus Long (Chief Executive, Independent International Organisation for Certification and IAF Conformity Assessment Body Advisory Committee Chair), with panellists including Sheronda Jeffries (Technical Leader, Cisco Systems and IAF User Advisory Committee Vice-Chair), Amina Ahmed (Arab Accreditation Cooperation Chair and Chief Executive, Emirates International Accreditation Centre), Pavel Castka (Professor, University of Canterbury) and Eve Christine Gadzikwa (Chief Executive, Southern African Development Community Accreditation Services). H.E Omar Suwaina Al Suwaidi (Under-Secretary, United Arab Emirates Ministry of Industry and Advanced Technologies) will deliver opening remarks.

The session will highlight topics such as how conformity assessment can help to enhance trust in ISO standards; how processes used during pandemic lockdowns have continued to deliver audits and assessments; how services such as accreditation, certification, testing, inspection, and validation and verification can continue to ensure trust is maintained during periods of accelerating change; key techniques and tools that will see digitalisation, data use and new technology play a more crucial role in conformity assessment; and the needs of conformity assessment users as the delivery of conformity assessment evolves.

The session will be held on 20 September from 18:00-19:00 GST (UTC+4). More information and registration are available here.

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ILAC welcomes O’ZAKK, Uzbekistan

We welcome Uzbek Center for Accreditation (O’ZAKK), Uzbekistan, as a Full Member of ILAC.

O’ZAKK joined ILAC as an Affiliate member on 19 March 2018 and then became an Associate Member on 15 April 2020.  As O’ZAKK is a signatory to the APAC MRA for the accreditation of calibration and testing laboratories using ISO/IEC 17025, O’ZAKK has also been granted signatory status to the ILAC MRA and therefore, Full membership of ILAC. 

We welcome O’ZAKK as a Full Member and look forward to working with our O’ZAKK colleagues.

The full list of signatories to the ILAC MRA is available here.

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ITU-IAF-ILAC MoU re-signed!

The International Telecommunications Union (ITU), the International Accreditation Forum (IAF) and ILAC have reviewed and re-signed the Memorandum of Understanding (MoU). 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.

Further details and the MoU are available here.

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IAF and ILAC launch podcast series

IAF and ILAC are excited to announce the launch of our new podcast, Accreditation Matters. This podcast series will feature 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 our first episode, Brendon Moo of the National Association of Testing Authorities (NATA) interviews Kylie Sheehan of the Joint Accreditation System of Australia and New Zealand (JAS-ANZ), IAF MLA Management Committee Chair, and Jennifer Evans of NATA, ILAC Arrangement Management Committee Chair, on the role of accreditation and accredited conformity assessment services within the quality infrastructure community.

Ms. Evans and Ms. Sheehan highlight the importance of accreditation and the IAF Multilateral Recognition Arrangement/ILAC Mutual Recognition Arrangement, their contribution to sustainability, and the work of IAF, ILAC, NATA and JAS-ANZ. They also share their views on the IAF and ILAC project to create a single international organization for accreditation.

Listen to our first episode now on Spotify, Apple Podcast and Google Podcasts

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