An important step forward in the fight against cancer in Italy was taken with the accreditation of the first structures for prevention and treatment of oncological diseases. The medical laboratories of the IRCSS Oncological Reference Center – Department of Research and Advanced Cancer Diagnostics in Aviano (province of Pordenone) and of the University Hospital of Padua UOC Pediatric Oncohematology have been accredited by Accredia, the Italian Accreditation Body, according to the international standard ISO 15189 “Medical laboratories – Requirements for quality and competence”.
This is the first case of accreditation in Italy of two structures entirely dedicated to medical analysis for the prevention, diagnosis, treatment and rehabilitation of oncological diseases. To issue the accreditation, Accredia verified the competence of the laboratories to conduct the tests following the requirements defined in the ISO standard. These checks are repeated periodically to ensure that the requirements are maintained over time.
Accreditation according to ISO 15189 ensures quality laboratory medical care in line with a standard of excellence that brings together the best rules defined at an international level, recognized and adopted throughout the world, for the benefit of both patients and healthcare professionals. Laboratory medicine is of increasingly central importance within the system of prevention, diagnosis, monitoring and guidance of therapies, including oncological ones. It is estimated that today about 80% of clinical decisions are based on tests performed by medical laboratories.
The standard provides for the verification, both in terms of conformity of the management system and of technical adequacy of the laboratory, of all the processes involved in the conduct of the accredited tests, including personnel competence, appropriateness of the tests, sampling and transport of samples, work environment, metrological traceability of results, quality assurance, interpretation of test results by medical staff and communication of the outcome to the patient.
The attestation issued by Accredia flanks, without replacing it, the so-called institutional accreditation of the National Health Service, and is a complementary tool, aimed at improving health services and the efficiency of the medical laboratory, and ensuring that the results of the analyses are reliable, with the aim of protecting public health and offering the community safe and quality healthcare.
In particular, the accreditation of the laboratory of the Oncological Reference Center of Aviano includes tests concerning the therapeutic monitoring of oncolytic drugs, the research into mutations and somatic rearrangements, genetic tests for mutations and germline polymorphisms.
The Pediatric Oncohematology Laboratory of Padua accreditation includes research regarding the main genetic-molecular lesions associated with leukemia, such as NOTCH1 and FBXW7 mutations, the t(8;14) and t(2;5) translocations. The accreditation also covers the screening for research into Soft Tissue Sarcomas and the mutagenic analysis with the NGS system and Sanger sequencing.
Cybersecurity Program Manager Ashley Kamauf has been selected as one of only two people from the United States to represent the American National Standards Institute (ANSI) for the ISO/IEC 17020 Revisions Working Group
ISO/CASCO made the decision to revise ISO/IEC 17020 in December of 2022. Over the past few years, similar standards have been revised, and in order to more closely align with those standards, ISO/IEC 17020 will be revised as well. The updated standard will incorporate revisions determined by the working group, as well as items from the ILAC P15 publication.
A2LA’s Cybersecurity Program Manager Ashley Kamauf has been selected as one of only two people from the United States to represent the American National Standards Institute (ANSI) for the ISO/IEC 17020 Revision Working Group. Kamauf was nominated for the working group by Trace McInturff, A2LA’s Vice President of Accreditation Services and she was selected based on her extensive knowledge of the standard and pain points for organizations in the industry.
“I am very excited to participate in the working group and have the opportunity to impact the trajectory of the standard moving forward,” said Kamauf. “I believe my experience with both training and managing many different types of inspection bodies will be beneficial to the group in achieving our goals.”
ISO/IEC 17020 Working Group meetings will take place in Geneva, Switzerland, and the group will take up to three years to create, finalize, approve, and publish the revised standard.
“A2LA is very pleased that Ashley has been selected by ANSI as one of the United States experts to participate on the newly created ISO/IEC 17020 Working Group,” said Trace McInturff, Vice President, Accreditation Services. “Ashley brings a wealth of inspection expertise to the working group and we are happy to be able to support ISO/CASCO in this very critical activity.”
For more information about A2LA’s ISO/IEC 17020 Inspection Body Program, visit https://a2la.org/accreditation/inspection-body/.
Media Contact: Wallis Shamieh; email@example.com; 301-644-3230
A2LA is a non-profit, non-governmental, third-party accreditation body, offering internationally recognized accreditation services to testing and calibration laboratories, inspection bodies, biobanking facilities, stand-alone sampling organizations, proficiency testing providers, reference material producers, and product certifiers. For more information, visit https://a2la.org/.
The Republic of Kazakhstan is a young state in Central Asia with a little over 30 years of independent history. Located in the very center of the Eurasian continent, surrounded by major geopolitical players, our country strives to constantly improve its competitiveness, and above all, in the economy and trade. Our state considers accreditation as one of the main tools for achieving success. National Center for Accreditation (NCA) – a state accreditation body under the Ministry of Trade and Integration of Kazakhstan – does not stop at assessing the already traditional for the country, scopes of accreditation, and is constantly introducing new schemes into its work. One of them is biobanking.
The term “Biobank” came into use by scientists and entrepreneurs in Kazakhstan not so long ago. The development in Kazakhstan of such promising areas such as plant and livestock breeding, transplantation and transfusion, treatment of genetically determined diseases and many others turned out to be impossible without biobanks – specialized repositories for the organized collection, labeling, processing, storage and analysis of samples of biological materials and related data for scientific and biomedical research.
Not every repository of biological materials can be called a biobank. Specially selected collections of plants and animals or their biomaterials, including samples taken from humans, can be used in research and clinical care only under sufficiently stringent conditions for any manipulation with them.
The scope of biobanking in Kazakhstan has changed a lot over the past thirty years. It began with small, mostly university repositories that were created for research and specific projects needs. Gradually, institutional and state-supported repositories, commercial biological repositories, population and virtual biobanks have developed.
However, a real breakthrough in the history of biobanking began with the development and adoption of the international standard ISO 20387 “Biotechnology — Biobanking — General requirements for biobanking”. The standard was created to build confidence in biobanking. It establishes requirements that allows biobanks to demonstrate high competence in their work and the ability to provide biological material and the related data of an appropriate quality, which in turn, will ensure a high level of research, development or services.
Since 2020, the National Center for Accreditation of Kazakhstan has been working actively on the implementation of biobank accreditation schemes. As part of the promotion of the ISO 20387 standard, NCA specialists have held webinars with the involvement of a foreign lecturer for the target audience of scientists, animal breeders and medical workers. As well as training for biobank staff and seminars for university teachers and students in order to build the capacity of technical experts.
The National Center for Accreditation of Kazakhstan has published a video and posts, articles and interviews are regularly released on the official website and social networks on the development of biobanking.
NCA specialists have received theoretical and practical training and visited accredited biobanks in countries such as South Korea and India. On the basis of the skills and knowledge acquired, three specialists have been awarded the title of expert bio-banking auditors. NCA’s procedural documents have been amended to ensure that we are ready to accept applications for the initial accreditation of biobanks.
Biobanks in Kazakhstan have shown particular interest in the standard. Today, about 2-3 potential applicants in our country are preparing for accreditation. Accreditation is seen as a good motivation for biobank staff. Accreditation will contribute to positioning the biobank as an organization that complies with all the requirements established by the standard for proper record keeping, clinical and diagnostic control, implementation of appropriate management of material resources and personnel, maintaining feedback with consumers, monitoring quality, ensuring the effectiveness of services provided and taking into account the opinions of patients.
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.
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:
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.
The Irish National Accreditation Board (INAB), which is part of the Health and Safety Authority, published Ireland’s first ever Strategy for Accreditation in May 2022. The Strategy sets out a vision and an ambitious roadmap for accreditation from 2022 to 2026. It was developed through intensive stakeholder engagement, market analysis and consultations over the course of 2021. Four strategic priorities will direct the strategy for Accreditation over the 5-year period. As part of this Strategy, INAB wants to grow the number of accredited Conformity Assessment Bodies in Ireland to meet demand and support Irish industry. The Strategy for Accreditation will be delivered through specific and detailed actions across four key priority areas:
Under each of the priority areas are clear goals and objectives that are and will be implemented throughout the next 4 years. The implementation of the Strategy sets out a clear path for how Ireland can utilise the many benefits of accreditation. We are now in the process of implementing the strategy through the programme of work each year, that contain actions and key performance indicators for the year ahead.
The Accreditation Strategy may be accessed here.
In celebration of World Accreditation Day, the Saudi Accreditation Centre held a seminar under the title “Accreditation: Sustainability in Economic Development and the Environment” via remote video communication with participation from the international accreditation bodies and national centres. The seminar was attended by more than 100 specialists and interested attendees.
The Saudi accreditation centre covered many topics, including environmental commitment as a source of sustainability for the national economy, the waste management policy in Saudi Arabia and sustainable development goals. Moreover, Mr Hassan Al-Wahaibi, the Deputy Executive Director of Operations at the Saudi Accreditation Centre, gave a comprehensive presentation of the centre’s services, procedures, and regulations, in addition to the Jordanian accreditation system and the sustainable development goals in the Kingdom of Jordan.
Dr Adel bin Abdulrahman Al-Qaid, the Executive Director of the Centre, opened the seminar by speaking of the Centre’s goals and its contribution to reaching the Kingdom’s quality system to the top ten countries in the world by 2030 and the Saudi Accreditation’s endeavour to raise awareness of the importance of accreditation and quality in all sectors.
The seminar was attended by the Chief Executive Officer of the British Accreditation Authority, Mr Matt Gantley, who confirmed the essential role of accreditation in the quality infrastructure. Mr Gantley spoke about the contribution of mutual recognition between international accreditation bodies to make the exporting goods easier and less costly to reach new markets. Then, Mr Gantley stated that accreditation has a significant contribution to the UK economy, ranging from 600 million to one billion pounds sterling, according to studies by the London Group.
Dr Abdullah Al-Sibai, CEO of the National Centre for Waste Management, reported that the transition to a circular economy will contribute to a domestic product of around 120 billion by 2035. Dr . Al-Sibai also stated that the majority of recycling operations are not economically feasible. The National Centre for Waste Management in Saudi Arabia is currently working to issue technical guidelines on the mechanism for implementing waste management activities. The centre is focusing on achieving its mission based on the principle of circular economy to contribute to environmental protection and quality of life.
The seminar was also enriched by Eng. Lana Marashda, Director of the Jordanian Accreditation Unit. Eng. Marashda spoke about the direct connection of accreditation with sustainable development goals. Then, Eng. Marashda emphasised that the accreditation gives confidence in the purposes used in protecting the environment. At the end of her speech, she mentioned that water quality control laboratories in the Kingdom of Jordan are obligated to obtain accreditation.
Eng. Ahmed Al-Malki, the Chairman of the Council of the Saudi Society for Quality in Medina, stated that the environmental protection activities need to be approved to increase their credibility, and the presence of environmental protection associations contributes to creating a culture and providing initiatives to address environmental issues. He added that the global economy during the last twenty years had doubled fifteen times, and with this massive transformation, there has been an enormous consumption of natural resources that affects the concept of sustainable development and the need to ensure sustainable protection to preserve the resources for future generations.
The symposium closed with a speech by Eng. Yasser Al-Shehri, the Environmental Advisor at the National Centre for Monitoring Environmental Compliance in Saudi Arabia. Eng. Al-Shehri stated that the National Environment Strategy aspires to raise the level of environmental commitment for all development sectors and enables the National Centre for Environmental Compliance to the environmental commitment by considering the air quality and safety. The centre will have a monitoring station in every region and governorate in the Kingdom of Saudi Arabia to calculate the spread of pollutants.
Strategic Planning 2023 – 2027
Those companies who wish to survive in an increasingly globalized and competitive environment must set their goals and objectives accordingly. Strategic planning plays a crucial role in this case since it provides a set of tools to reach the organization’s potential. However, this is without losing sight of the fact that a rapidly changing and uncertain environment requires the development of internal operations that employ transcendental management processes. This is why, in an organizational environment, strategic planning is one of the tools that most contribute to developing solution alternatives, making decisions, applying best practices, evaluating results, and facilitating interdisciplinary communication and coordination, as it includes processes that extend beyond defining work objectives and direct efforts towards analyzing the environment and defining action-plans. In conclusion, strategic planning connects all the company’s teams, translating the company’s mission, vision, and goals into tangible results and reducing problems, stimulating participation, and stirring concern of all, since it is considered a process that enables the participants to optimize the use of their resources for the achievement of a desired objective. After renewing its planning exercise after five years, ONAC achieve most of its goals by 2022, including updating recognition agreements and increasing the number of accredited OECs. As part of this project, ONAC, with the assistance of SUMMUM, is developing a comprehensive roadmap that will guide its efforts between 2023 and 2027. In this roadmap, its purpose, its strategic pillars, and its objectives will be redefined, as well as indicators demonstrating the organization’s progress will be developed. Since August, several activities have been undertaken to determine the path ONAC has taken with respect to the strategic planning defined for 2017 to 2022. These activities include conducting focus groups with leading evaluators of accreditation schemes and conducting interviews with ONAC management personnel. In addition, this includes key members of entities involved in direct, indirect or government interests. The management team and process leaders participated in a three-day workshop at the beginning of September, in which innovative and dynamic work methodologies were employed in order to evaluate the current state of the ONAC team, as well as the external context. Based on the analysis of trends, it was possible to construct a SWOT matrix. This allowed the concepts for the creation of the redesigned MEGA, the strategic pillars, objectives, and indicators, to be grounded.
At the end of the workshop, an outdoor activity was held to reflect on the consolidation of the ONAC team and the challenging road ahead. It is expected that, by December 2022, the agency will make public the revised roadmap after approval by its Board of Directors. We will share the results with the management team and SUMMUM in the final quarter of the year. By doing so, we will be able to finalize the presentation for the Board of Directors in December. Following approval by the Board of Directors, the roadmap the next five years will be disseminated in the all works teams of our collaborators.
ONAC: Reference Material Producers Accreditation Scheme ISO 17034
The development of more accurate measuring equipment and the need for more accurate and reliable data for informed decision making in scientific and technological disciplines is a worldwide trend, In addition, the general requirements for the competence of testing and calibration laboratories, as defined in the international standard ISO/IEC 17025, require them to adopt standardized and verified test methods, which can be achieved through the use of certified reference materials. In this way, reference materials are essential for the industry and supporting sectors. They have known and specified properties, with a given value, an associated uncertainty, and a statement of metrological traceability. The reference material certificate can only be issued by a Reference Material Producer accredited under ISO 17034, which is also responsible for assigning relevant property values and uncertainties.
The National Accreditation Body of Colombia, ONAC, through its survey for the Identification of Needs for the Development of New Accreditation Services, identified the need for the development of the service not only for testing, calibration and medical laboratories, who use these reference materials to establish metrological traceability in their measurement results, but also by different industrial sectors: metallurgical, construction, environmental sectors, among others, who agree that accreditation is a means to determine the technical competence of reference material producers to produce reference materials, and a marketing tool, given by the generation of confidence in quality given to end customers.
The development of the service was carried out with and funded by the United Nations Industrial Development Organization (UNIDO) (under the Global Quality and Standards Programme (GQSP)), with the help of the U.S. accreditation body, the American Association for Laboratory Accreditation (A2LA). The latter guided training in ISO 17034 for technical professionals and internal ONAC staff involved in the accreditation and assessment processes under the international standard. ONAC was also able to observe a Reference Material Producer assessment conducted by A2LA. With this training, the ONAC evaluators of the scheme were qualified.
After a year and a half of work in the development of the service, the official launch of the accreditation scheme for producers of reference materials took place on July 6th, 2022 in Bogota, Colombia, with the participation of different entities such as: UNIDO, A2LA, the National Metrology Institute of Colombia (INM), the National Metrology Center of Mexico (CENAM), two laboratories interested in the accreditation service, the Ministry of Commerce, Industry and Tourism of Colombia, among others, all which had interventions on the different perspectives of the importance of the service in Colombia and in the region.
Currently there are three laboratories interested in accreditation with ONAC under the scheme of reference material producers, knowing that accreditation with ONAC leads to continuous improvement in their management system and activities for the production of reference materials and gives them added value by meeting the quality requirements demanded by the market and articulation with the requirements of ISO/IEC 17025 and is a differentiating element that will give them a competitive advantage in the provision of their services.
EIAC attended ISO meetings
The Chief Executive Officer (CEO) of Emirates International Accreditation Centre (EIAC), Ms. Amina Ahmed Mohammed and other staff members attended the ISO annual meetings held on 19-23 September 2022 in Abu Dhabi, UAE. Ms. Amina who is also the Chair of Arab Accreditation Cooperation (ARAC) participated as panelist in the ISO Session titled “Has covid launched the digital transformation of conformity assessment “. Mr. Marcus Long Chief Executive of Independent International Organisation for Certification (IIOC) was the moderator of this ISO session.
During a Q & A session, she said the accreditation community did organize itself promptly as soon as the pandemic was announced, fast response working groups were created, and both organizations shifted their work to remote work and applied their extraordinary event procedures that existed before the pandemic. ILAC and IAF did also make sure that the confidence in conformity assessment result is preserved especially during the pandemic where these services are sometimes literally vital. A website was created to collect questions and publish FAQs and guidance, this allowed Conformity Assessment Bodies (CABs) and stakeholders from around the world to continue providing their services in a harmonized and effective way.
She further said, facing to such extraordinary event, there was surely a need to harmonize practices worldwide, that’s why ILAC, IAF and the regional Accreditation Groups did promptly establish the mechanisms to have an agreement on the way to continue providing CA services while preserving the confidence in the Multilateral arrangements. This is not limited to the pandemic situation. The pandemic did maybe accelerate the process, but the accreditation community was since many years harmonizing its digital work and the adaptation to new technologies imperatives.
In response to another question she said, the main purpose of accreditation is to provide confidence in the competence of the conformity assessment services provided within the national, regional and global quality infrastructure. By building this trust, accreditation facilitates trade, allows for comparability of results worldwide, and hence consumer protection and economic growth. With the development of new schemes and emergence of new industries that require conformity assessment activities, accreditation adapts by gathering the experts from around the world to establish the chain of trust and cover it by it Multilateral recognition arrangements.
Photo: EIAC CEO participating in ISO panel discussion.
EIAC accredited Kazakhstan Standards for Halal Certification
Emirates International Accreditation Centre (EIAC) accredited the Halal Certification Department of Kazakhstan Institute of Standardization and Metrology according to UAE halal standards. Ms. Amina Ahmed Mohammed CEO of EIAC presented the accreditation certificate in presence of Prime minister of Kazakhstan His Excellency Alikhan Smailov and Minister of Energy of UAE His Excellency Suhail Mohamed Al Mazrouei in a prestigious ceremony held in Emirates Palace Abu Dhabi.
Prime Minister of Kazakhstan along with his delegation was on a working visit to the UAE.
Photo: EIAC CEO presenting accreditation certificate to KAZ standards.
Ras Al Khaimah Police – the first Forensic Investigation Unit in Gulf Region to get accreditation according to the ISO/IEC 17020
The Emirates International Accreditation Centre (EIAC) has granted accreditation to the Forensic Investigation Unit of Ras Al Khaimah (RAK) Police in accordance with the ISO/IEC 17020 for the scopes of Questioned Documents, Fire and Arson Investigation, Forensic Autopsy & Histopathology, Clinical Forensic Medicine and Women and Child Examination. Ras Al Khaimah police is the first police unit in gulf region that got ISO/IEC 17020 accreditation for the subject scope.
Ras Al Khaimah is one of the seven Emirates of United Arab Emirates (UAE) and is known for its pharmaceutical, ceramics, cement industries, international trade through RAK Ports. Tourism is also a booming sector in Ras Al Khaimah. Its sandy beaches and islands attract hundreds of thousands of tourists every year.
EIAC received approval from ISQuaEEA
The External Evaluation Award Committee (EEAC) of the International Society for Quality in Health Care External Evaluation Association (ISQuaEEA) has endorsed the
EIAC Accreditation Standard for Healthcare Providers after independent assessment.
The EIAC Accreditation Standard for Healthcare Providers covers the scopes of Hospitals, Clinics, Day Surgery Centers, Fertility Centers, Home Health Services, Medical Tourism and Telehealth Services.
Arab regional forum on voluntary Third-Party Assurance (vTPA)
EIAC CEO participated in Arab Regional Forum on Voluntary Third-Party Assurance in Food Sector Approach and Modalities in the Arab Region, which was held in Amman, Jordan.
The forum was conducted by the United Nations Industrial Development Organization (UNIDO) in cooperation with the Arab Industrial Development, Standardization and Mining Organization (AIDSMO) and Swedish International Development Cooperation Agency (Sida). Ms. Amina Ahmed Mohammed CEO of EIAC and Chair of Arab Accreditation Cooperation (ARAC) addressed the forum. She gave overview of the food safety quality assurance programs in the arab region. She informed the participants that a similar voluntary Third-Party Assurance (vTPA) certification scheme for Food establishments/ Food Business Operators (FBOs) was introduced in Dubai in 2008. The scheme was based on Codex Alimentarius CAC/RCP 1-1969 and regulatory body Food Control Department’s Requirements. She informed that Emirates International Accreditation Centre (EIAC) which was known as Dubai Accreditation Department (DAC) at that time initiated and started the accreditation scheme for third party food safety management systems certification bodies to certify food establishments/ Food Business Operators (FBOs) for HACCP based requirements. She said the EIAC’s experience can be utilized throughout the region in this regard.
Photo: EIAC CEO addressing Arab regional forum on vTPA.
Photo: Arab regional forum group photo.
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.