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The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. ISO 9002 is a model for quality assurance in production and installation. ISO 9003 for quality assurance in final inspection and test. ISO 9004 gives guidance on achieving sustained organizational success.
Accreditation is the independent, third-party evaluation of a conformity assessment body against recognised standards, conveying formal demonstration of its impartiality and competence to carry out specific conformity assessment tasks.
Product certification or product qualification is the process of certifying that a certain product has passed performance tests and quality assurance tests, and meets qualification criteria stipulated in contracts, regulations, or specifications.
ISO/IEC 17025General requirements for the competence of testing and calibration laboratories is the main standard used by testing and calibration laboratories. In most countries, ISO/IEC 17025 is the standard for which most labs must hold accreditation in order to be deemed technically competent. In many cases, suppliers and regulatory authorities will not accept test or calibration results from a lab that is not accredited. Originally known as ISO/IEC Guide 25, ISO/IEC 17025 was initially issued by ISO/IEC in 1999. There are many commonalities with the ISO 9000 standard, but ISO/IEC 17025 is more specific in requirements for competence and applies directly to those organizations that produce testing and calibration results and is based on more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. Material in the standard also forms the basis for accreditation from an accreditation body.
ISO 15189 Medical laboratories — Requirements for quality and competence is an international standard that specifies the quality management system requirements particular to medical laboratories. The standard was developed by the International Organisation for Standardization's Technical Committee 212. ISO/TC 212 assigned ISO 15189 to a working group to prepare the standard based on the details of ISO/IEC 17025:1999 General requirements for the competence of testing and calibration laboratories. This working group included provision of advice to medical laboratory users, including specifics on the collection of patient samples, the interpretation of test results, acceptable turnaround times, how testing is to be provided in a medical emergency, and the lab's role in the education and training of health care staff. While the standard is based on ISO/IEC 17025 and ISO 9001, it is a unique document that takes into consideration the specific requirements of the medical environment and the importance of the medical laboratory to patient care.
The Health Sciences Authority (HSA) is a statutory board under the Ministry of Health of the Government of Singapore. It is a multi-disciplinary agency responsible for applying medical, pharmaceutical, and scientific expertise to protect and advance public health and safety.
The International Laboratory Accreditation Cooperation or ILAC started as a conference in 1977 to develop international cooperation for facilitating trade by promoting the acceptance of accredited test and calibration results. In 1996, ILAC became a formal cooperation with a charter to establish a network of mutual recognition agreements among accreditation bodies that would fulfil this aim.
An independent test organization is an organization, person, or company that tests products, materials, software, etc. according to agreed requirements. The test organization can be affiliated with the government or universities or can be an independent testing laboratory. They are independent because they are not affiliated with the producer nor the user of the item being tested: no commercial bias is present. These "contract testing" facilities are sometimes called "third party" testing or evaluation facilities.
The South African National Accreditation System (SANAS) is the official accreditation body for South Africa. Founded in 1996, SANAS is headquartered in Pretoria, South Africa. SANAS accreditation certificates are a formal recognition by the Government of South Africa that an organisation is competent to perform specific tasks.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".
The College of American Pathologists (CAP) is a member-based physician organization founded in 1946 comprising approximately 18,000 board-certified pathologists. It serves patients, pathologists, and the public by fostering and advocating best practices in pathology and laboratory medicine.
British Approvals Service for Cables is an independent accredited certification body headquartered in Milton Keynes, United Kingdom. Here, the organization's dedicated testing laboratory also operates which is believed to be the largest of its type in Europe. BASEC was established in 1971 and principally provides product certification services for all types of cable and wire, ancillary products and management systems within the cable industry. The organization maintains operations throughout the world including Africa, Middle East, America, Asia and Europe.
The United Kingdom Accreditation Service (UKAS) is the sole national accreditation body recognised by the British government to assess the competence of organisations that provide certification, testing, inspection and calibration services. It evaluates these conformity assessment bodies and then accredits them where they are found to meet relevant internationally specified standards.
External quality assessment ('EQA), or external quality assessment schemes(EQAS) is a challenge of the effectiveness of a laboratory's quality management system, typically referring specifically to medical laboratories. The term external refers to the fact that that the laboratory's results are assessed by a third party. The most common EQA process is proficiency testing, in which an organization sends samples to a group of different laboratories and results are compared among the group. Retesting of the same sample by different laboratories and on-site visits to evaluate laboratory processes may also be part of an EQA scheme.
National Accreditation Board for Testing and Calibration Laboratories (NABL) provides accreditation to Conformity Assessment Bodies (Laboratories) in India. NABL Schemes include Accreditation (Recognition) of Technical competence of testing, calibration, medical testing laboratories, Proficiency testing providers (PTP) & Reference Material Producers (RMP) for a specific scope following ISO/IEC 17025, ISO 15189, ISO/IEC 17043 & ISO 17034:2016 Standards. It has Mutual Recognition Arrangement (MRA) with Asia Pacific Accreditation Cooperation (APAC), International Laboratory Accreditation Cooperation (ILAC).
Sundaram Medical Foundation is a community-centred, non-profit, trust hospital established in 1990 by S. Rangarajan. Sundaram Medical Foundation's main hospital premises operate at Shanthi Colony in the neighborhood of Anna Nagar while an outpatient facility operates at on Elango Salai Rd, Mogappair West, Ambattur Industrial Estate, Chennai.
The Central Institute of Fisheries Technology (CIFT) is an autonomous organization established by the government of India, engaged in research related to fishing and fish processing in the country. The institute has its headquarters in Matsyapuri, Willingdon Island, Kochi and is a subsidiary of Indian Council of Agricultural Research (ICAR), New Delhi, under the Ministry of Agriculture, India.
The National Association of Testing Authorities (NATA) is the recognised national accreditation authority for analytical laboratories and testing service providers in Australia. It is an independent, not-for-profit organisation, governed by a board of directors that has representation from NATA members, industry, government and professional bodies.
Fausta Shakiwa Mosha is a Tanzanian senior Laboratory consultant for the United States Association of Public Health Laboratories of East Africa for East and South Africa regions. She has been the Director for the National Health Laboratory Quality Assurance and Training Centre for the Ministry of Health since 2011.
The National Virus Reference Laboratory (NVRL) is located in UCD, Dublin, Ireland and is affiliated to the University College Dublin School of Medicine. The NVRL provides a diagnostic and reference service for clinicians in Ireland investigating viral infections. For over forty years, the NVRL have provided a virology diagnostic service to the Irish health service.
References
- ↑ Hacham, Haim; Tetro, Nurit; Kochavi-Azolai, Salit; Stern, Nava; Mizrahi, Dana; Lisenker, Anna; Gazit, Emanuel; et al. (2007). "Unification of the quality assurance systems of public health laboratories conformed to ISO 17025, ISO 15189, and ISO 9000: a major organizational change". Accreditation and Quality Assurance. 12 (8). Elsevier: 409–413. doi:10.1007/s00769-007-0262-9. S2CID 111340137.
- ↑ Aoyagi T, Kawai T (May 2006). "[Validation of the ISO 15189 trial assessment results of clinical laboratories--effects of accreditation and interpretation of ISO 15189]". Rinsho Byori (in Japanese). 54 (5): 486–93. PMID 16789419.
- ↑ Huisman W, Horvath AR, Burnett D, et al. (2007). "Accreditation of medical laboratories in the European Union". Clin. Chem. Lab. Med. 45 (2): 268–75. doi: 10.1515/CCLM.2007.037 . hdl: 11577/1775503 . PMID 17311523. S2CID 8175030.
- ↑ Spitzenberger F, Edelhäuser R (2006). "Accreditation of Medical Laboratories in Europe: Statutory Framework, Current Situation and Perspectives". Transfusion Medicine and Hemotherapy. 33 (5). S. Karger AG: 384–92. doi: 10.1159/000094738 .
- ↑ "National Reference Laboratories at the BVL". Federal Office of Consumer Protection and Food Safety. n.d.
- ↑ Webster, Charles (1988). The Health Services Since the War. HMSO. ISBN 0-11-630942-3.
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