External Quality Assessment
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External Quality Assessment
External quality assessment (ex q a) is the challenge of the effectiveness of a laboratory's quality management system. EQA typically refers specifically to the challenge of quality systems in a medical laboratory. The term external refers to the fact that an organizer outside of the laboratory's organisation provides a statement of quality to the laboratory. Organization Typically, an EQA scheme consists of several rounds per year. In each round several (or many) participants receive test items, which are also called samples. The EQA organizer is also called the provider. The organizer ensures that the test items are sufficiently similar and homogeneous, typically according to ISO 13528. Often the test items' properties and analyte concentrations are known to the organizer, but not disclosed to participants before the final report. However, there are also many schemes where the organizer doesn't know the sample composition. The participants' results are then compared to check ...
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Quality Management System
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO 9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information, and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality are increasingly tied to these factors. ...
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Medical Laboratory
A medical laboratory or clinical laboratory is a laboratory where tests are conducted out on clinical specimens to obtain information about the health of a patient to aid in diagnosis, treatment, and prevention of disease. Clinical Medical laboratories are an example of applied science, as opposed to research laboratory, research laboratories that focus on basic science, such as found in some academia, academic institutions. Medical laboratories vary in size and complexity and so offer a variety of testing services. More comprehensive services can be found in acute-care hospitals and medical centers, where 70% of clinical decisions are based on laboratory testing. Doctors offices and clinics, as well as skilled nursing and Nursing home, long-term care facilities, may have laboratories that provide more basic testing services. Commercial medical laboratories operate as independent businesses and provide testing that is otherwise not provided in other settings due to low test vol ...
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ISO 13528
ISO is the most common abbreviation for the International Organization for Standardization. ISO or Iso may also refer to: Business and finance * Iso (supermarket), a chain of Danish supermarkets incorporated into the SuperBest chain in 2007 * Iso Omena ("Big Apple"), a shopping center in Finland * Incentive stock option, a type of employee stock option * Independent Sales Organization, a company that partners with an acquiring bank to provide merchant services * Insurance Services Office, an American insurance underwriter * Intermarket sweep order, a type of limit order on financial markets * Iso (automobile), an Italian car manufacturer Arts and entertainment * Isomorphic Algorithms (ISOs), a fictional race in the digital world of '' Tron: Legacy'' * Iso (comics), a Marvel comics character Music * ''Iso'' (album), an album by Ismaël Lô * Iceland Symphony Orchestra * Indianapolis Symphony Orchestra, Indiana, US * International Symphony Orchestra, of Sarnia, Ontario and Port ...
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ISO 17025
ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories is the main ISO/IEC 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 somewhat more technical principles. Laboratories use ISO/IEC 17025 to implement a quality system aimed at improving their ability to consistently produce valid results. It is also the basis for accreditation from an accreditation body. ...
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ISO 15189
''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). 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 me ...
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International Laboratory Accreditation Cooperation
The International Laboratory Accreditation Cooperation or ILAC started as a conference in 1977 with the aim of developing international cooperation for facilitating trade by promotion of 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. The ultimate aim of the ILAC is increased use and acceptance by industry as well as government of the results from accredited laboratories, including results from laboratories in other countries. In this way, the free-trade goal of a 'product tested once and accepted everywhere' can be realised. See also * Accreditation * Good laboratory practice (GLP) * Institute for Reference Materials and Measurements (IRMM) * International Federation of Clinical Chemistry and Laboratory Medicine * ISO/IEC 17025 * Joint Committee for Traceability in Laboratory Medicine * Reference ran ...
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Accreditation Body
Accreditation is the independent, third-party evaluation of a conformity assessment body (such as certification body, inspection body or laboratory) against recognised standards, conveying formal demonstration of its impartiality and competence to carry out specific conformity assessment tasks (such as certification, inspection and testing). Accreditation bodies are established in many economies with the primary purpose of ensuring that conformity assessment bodies are subject to oversight by an authoritative body. Accreditation bodies, that have been peer evaluated as competent, sign regional and international arrangements to demonstrate their competence. These accreditation bodies then assess and accredit conformity assessment bodies to the relevant standards. An authoritative body that performs accreditation is called an 'accreditation body'. The International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) provide international recognitio ...
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Quality Assurance
Quality assurance (QA) is the term used in both manufacturing and service industries to describe the systematic efforts taken to ensure that the product(s) delivered to customer(s) meet with the contractual and other agreed upon performance, design, reliability, and maintainability expectations of that customer. The core purpose of Quality Assurance is to prevent mistakes and defects in the development and production of both manufactured products, such as automobiles and shoes, and delivered services, such as automotive repair and athletic shoe design. Assuring quality and therefore avoiding problems and delays when delivering products or services to customers is what ISO 9000 defines as that "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention aspect of quality assurance differs from the defect detection aspect of quality control and has been referred to as a ''shift left'' since it focuses on quality effor ...
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Health Protection Agency
The Health Protection Agency (HPA) was a non-departmental public body in the United Kingdom. It was an organisation that was set up by the UK government in 2003 to protect the public from threats to their health from infectious diseases and environmental hazards. The HPA's role was to provide an integrated approach to protecting public health in the UK. It did this by providing advice and information to the general public, health professionals, and local government and by providing emergency services, support and advice to the National Health Service (NHS) and the Department of Health. The HPA also had a lead role in helping preparations for new and emerging health threats, such as a bioterrorism or in the event of an emerging virulent disease strain. There were four HPA centres – at Porton Down in Salisbury, Chilton in Didcot, South Mimms in Hertfordshire, and Colindale in NW London. In addition, the HPA had regional laboratories across England and administrative headquarte ...
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United Kingdom
The United Kingdom of Great Britain and Northern Ireland, commonly known as the United Kingdom (UK) or Britain, is a country in Europe, off the north-western coast of the continental mainland. It comprises England, Scotland, Wales and Northern Ireland. The United Kingdom includes the island of Great Britain, the north-eastern part of the island of Ireland, and many smaller islands within the British Isles. Northern Ireland shares a land border with the Republic of Ireland; otherwise, the United Kingdom is surrounded by the Atlantic Ocean, the North Sea, the English Channel, the Celtic Sea and the Irish Sea. The total area of the United Kingdom is , with an estimated 2020 population of more than 67 million people. The United Kingdom has evolved from a series of annexations, unions and separations of constituent countries over several hundred years. The Treaty of Union between the Kingdom of England (which included Wales, annexed in 1542) and the Kingdom of Scotland in 170 ...
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Bundesanstalt Für Materialforschung Und -prüfung
The Federal Institute for Materials Research and Testing (german: , or BAM) is a German material research institute. History Its historical origins start in 1871, a year in which Germany was unified, as the ''Mechanisch-Technische Versuchsanstalt''. From 1904-19 there was the ''Königliches Materialprüfungsamt''. From 1920-45 there was the ''Staatliches Materialprüfungsamt'' (MPA) and from 1919-45 there was the ''Chemisch-Technische Reichsanstalt'' (CTR). In 1954 the ''Bundesanstalt für mechanische und chemische Materialprüfung'' was formed, becoming the ''Bundesanstalt für Materialprüfung'' in 1956. In 1969 it became a government agency (Bundesoberbehörde). In 1986 the name changed to ''Bundesanstalt für Materialforschung und -prüfung''. Function Within the interconnected fields of materials, chemistry, environment and safety, the main areas are: * Statutory functions relating to technical safety in the public domain, especially as regards dangerous materials and sub ...
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