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The Czech Accreditation Institute (CAI) was established as a national accreditation body by the Czech Republic on 1st January 1993. In January 2023, a festive meeting of CAI staff was held to celebrate the 30th anniversary. The meeting took place in the splendid surroundings of the historic town of Jindřichův Hradec, founded by the royal family of the Přemyslid in the 10th century.
Participants recalled the history of the establishment and operation of the CAI from its earliest beginnings to the present day.
In 1996 the initial peer-evaluation of CAI was undertaken and in 1998 the CAI signed the EA Multilateral Agreement (MLA) to become the first EA MLA signatory in Central and Eastern Europe and in doing so gained international recognition.
Growing acceptance of accreditation by regulatory bodies in UAE
United Arab Emirates (UAE) is considered one of the most progressive countries in the middle east region. UAE is leading in various fronts including scientific, educational, and economic fields in the region. The regulatory authorities and governmental conformity assessment bodies are widely adopting accreditation as a benchmark while establishing the highest levels of service standards. Various governmental conformity assessment bodies have achieved accreditation from Emirates Internal Accreditation Centre (EIAC) and other accreditation bodies to the ISO/IEC 17025, ISO/IEC 17020, ISO/IEC 17065, and ISO 15189 standards. It is worth mentioning that some of the major governmental organizations who conduct regulatory inspections have achieved ISO/IEC 17020 accreditation from EIAC such as:
EIAC accredited first Proficiency Testing (PT) provider
EIAC’s Accreditation scheme for Proficiency Testing (PT) Providers is fully functional.
The accreditation scheme was launched in 2020.
Global Proficiency Testing Company (GPTC), Dubai become the first company to receive EIAC’s accreditation according to the ISO/IEC 17043:2010 standard. GPTC’s scope of accreditation covers Water Chemistry for Sulphate, Chloride and pH Value, Water Microbiology for Legionella, TBC, Coliform, Fecal coliforms, E. Coli, Fecal Streptococci, Clostridium perfringens, Pseudomonas aeruginosa, and Construction Material (Water Proofing Membrane) for Tensile, Elongation and Thickness. The GPTC’s scope also covers Mass Calibration for Conventional Mass with Precision Weights (1 mg – 50 kg).
Ms. Amina Ahmed Mohammed EIAC CEO congratulated the management of GPTC. She said “the availability of accredited PT providers locally will enhance the prospects of conformity assessment bodies’ participation in PT programs as this would be time efficient and economical”.
EIAC CEO Ms. Amina Ahmed Mohammed is handing over accreditation certificate to Mr. Zahid Mahmood Managing Director of Global Proficiency Testing Company (GPTC), Dubai
EIAC’s accreditation scheme for medical tourism launched
The Emirates International Accreditation Centre (EIAC) formally launched an accreditation scheme for medical tourism on 9 November 2022. The scheme was launched at the DXH Partner Connect 2022 event of the Health Tourism Department of the Dubai Health Authority (DHA). Engr. Alia Ismail Al Marzouqi Director of Healthcare Sector-EIAC and Mr. Mohammad Al Muhairi Director of Health Tourism Department-DHA were present at the event. Ms. Khawla Mohamed Al Zarooni Head of Calibration Laboratories Accreditation-EIAC presented the salient features of the scheme. During Question Hour, Dr. Qasim Al Shamsi head of Healthcare Sector-EIAC explained the various aspects of the accreditation scheme.
The accreditation criteria is defined in EIAC Accreditation Standard for Healthcare Providers (EIAC-RQ-HCO-003) Annex A. The EIAC’s accreditation standard is approved by the International Society for Quality in Health Care External Evaluation Association (ISQuaEEA).
Launching ceremony of EIAC’s accreditation scheme for medical tourism
EIAC’s new accreditation scheme for certification bodies
The Emirates International Accreditation Centre (EIAC) has launched new accreditation schemes for management systems certification bodies according to ISO 17021-1 main accreditation criteria in the following areas:
The Emirates International Accreditation Centre (EIAC) has also launched a new accreditation scheme for persons certification bodies in collaboration with the Pest Control Section of Public Health Services Department of Dubai Municipality. The main accreditation criteria is ISO 17024 and the scheme is in the field of “Pest Control” for the following certifications:
EIAC attended the ARAC annual meetings & general assembly in Cairo, Egypt
The 10th annual meetings and general assembly of Arab Accreditation Cooperation (ARAC) were held from 4 – 8th December 2022 in Cairo, Egypt. A delegation from the Emirates International Accreditation Centre (EIAC) attended the annual meetings and general assembly. Ms. Amina Ahmed Mohammed CEO of EIAC who is the current chair of ARAC presided over the ARAC general assembly. Delegates from nineteen member countries and stakeholders attended the meetings. During the meetings the 10th founding anniversary of ARAC was also celebrated.
EIAC’s participation in ARAC general assembly
EIAC’s participation in ARAC general assembly
EIAC is conducting a series of trainings for the healthcare sector
The Emirates International Accreditation Centre (EIAC) is conducting a series of trainings for the healthcare sector. Four trainings are planned for assessors and laboratory staff on the ISO 15189:2022 standard and EIAC accreditation requirements.
The training facilitators are Ms. Sheila Woodcock and Mr. David Ricketts. Ms. Sheila Woodcock serves as the Convenor of ISO TC212 WG1 Quality and competence in the medical laboratory, one of the 5 Working Groups within the ISO TC212 Clinical laboratory testing and in vitro diagnostic test systems. She served as Project Leader for the revision of ISO 15189 that was published in December 2022. Mr. David Ricketts is a member of ISO TC212. He was part of the core drafting team for the revision of ISO 15189, as well as being involved in writing other laboratory standards including being the project lead for the lastest version of ISO 22870.
Two training sessions are planned for assessors for healthcare facilities including hospitals, day surgery centers, clinics, fertility centers, home health services, medical tourism and telehealth services. The training is focused on EIAC Accreditation Standard for Healthcare Providers (EIAC-RQ-HCO-003). The EIAC standard is approved by the International Society for Quality in Health Care External Evaluation Association (ISQuaEEA). Ms. Angeliki Katsapi, Dr. Alan Taylor and Dr. Bryan Woodward are the resource persons.
EIAC’s training for healthcare assessor and professionals
Forums in the form of a TV set for bodies accredited by Laboratories and Healthcare divisions
Cofrac organized two forums in the form of a TV set in less than two months. The first one, in November 2022 for the Healthcare division and the second in January 2023, for the Laboratories division.
The Healthcare division forum
After the first event organized and held face-to-face in 2018, the long awaited – since 2020 – second Healthcare forum was completely redesigned and took place in the form of a TV set, filmed and broadcast live from Paris in November 2022. The topic for this edition was “Accreditation in Healthcare: the evolutions” and was dedicated to the professionals concerned (medical biologists, ACP doctors, management, technicians, bio-medical engineers, risk managers, quality managers, …).
The programme for this half-day event included:
The event was punctuated by a live survey to collect participants’ knowledge on the upcoming version of ISO 15189 standard, a presentation of the results of a study on accreditation and medical biology laboratories led by a specialised agency and the video from the Deputy General Director of Health.
531 people were connected during the live broadcast. 78 persons answered the feedback form, with 99.9% indicating they were satisfied or very satisfied with this program and new meeting platform. Since the live broadcast, this event has been viewed more than 863 times via the replay option.
The Laboratories division forum
As with the second event for the Healthcare division, the 11th edition of “Accreditation and Laboratories” took place for the first time remotely, again filmed and broadcast live from Paris in January 2023. Some of the members of the Health division were present on the “TV set” to encourage their colleagues in this new presentation style.
This event dedicated by the Laboratories division to accredited bodies and applicants according to the ISO/IEC 17025, ISO 17034 or ISO/IEC 17043 standards gathered 530 people in the “live studio”.
This year, the program for the event included the following topics:
The event was intersperced by live surveys to collect participants’ understanding on deviation trend and seven videos. The first video was a testimony from a laboratory, and the others were Chaired by the Presidents and Vice-Presidents of the different accreditation committees who questioned the Cofrac teams in the studio. To finish there was a remote exchange with a Representative from Accredia covering EA (LC and MAC) and ILAC (AIC) international work.
119 participants answered the feedback questionnaire with 98% indicating they were satisfied or very satisfied with this program and the new meeting style. Since the live broadcast, this event has been viewed more than 998 times using the replay function.
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
Ashley-Kamauf
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; wshamieh@a2la.org; 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:
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.
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.