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.[1] 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.[1] 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 first version of the standard was published in 2003, and it was revised in 2007 to align more closely to ISO/IEC 17025.[1] A third edition of the standard was published in 2012, which revised the layout again and added a section on laboratory information management.[2]

See also

External links


  1. ^ a b c Pereira, P. (February 2017). "ISO 15189:2012 Medical laboratories - Requirements for quality and competence". Westgard QC. Retrieved 28 November 2017.
  2. ^ Rej, R. (11 September 2013). "What's new in ISO 15189: 2012?" (PDF). Association of Public Health Laboratories. Retrieved 28 November 2017.
College of American Pathologists

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.It is the world's largest association composed exclusively of pathologists certified by the American Board of Pathology, and is widely considered the leader in laboratory quality assurance. The CAP is an advocate for high-quality and cost-effective medical care. The CAP currently inspects and accredits medical laboratories under authority from the Centers for Medicare & Medicaid Services (CMS). Their standards have been called "the toughest and most exacting in the medical business." The CAP provides resources and guidance to laboratories seeking accreditation in programs for biorepositories, genomics, ISO 15189, and more. In November 2008, Piedmont Medical Laboratory of Winchester, Virginia became the first laboratory in the United States to be officially accredited under ISO 15189.

The CAP provides accreditation and proficiency testing to medical laboratories through its laboratory quality solutions programs. Early versions of proficiency testing—known as surveys—which laboratories use to help test and ensure accuracy, were first initiated in 1949. Laboratories first began receiving CAP accreditation in 1964, and the organization was later given authority to accredit medical laboratories as a result of the Clinical Laboratory Improvement Amendments (CLIA) of 1988.The CAP publishes checklists containing requirements pertaining to the performance of laboratory tests. The All Common Checklist (COM) contains a core set of requirements that apply to all areas performing laboratory tests and procedures.

Some requirements exist in both the COM checklist and in a discipline-specific checklist, but with a different checklist note that has a more specific requirement. In these situations, the discipline-specific requirement takes precedence over the COM requirement.

The COM checklist also describes the requirements for analytical validation/verification of the method performance specifications (i.e.

accuracy, precision, reportable range) that laboratories must perform for each test, method, or instrument

system before use in patient testing.The CAP opened a Washington, DC, office in 1970 and advocating for pathology in a legal and policy-oriented capacity remains a core mission of the organization, both through direct action and programs that connect pathologists to legislators.The CAP Foundation is the philanthropic arm of the organization and is classified as a 501(c)(3) charitable entity. Its flagship program, See, Test & Treat, partners with hospitals and clinicians to provide free cancer and HPV screening, as well as educational events, to underserved communities. The program served over 900 women in 2017.

European Federation of Clinical Chemistry and Laboratory Medicine

The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) (formerly EFCC) is a federation of national member societies of clinical chemistry and laboratory medicine from geographical Europe. EFLM has its registered office in Brussels and administrative office in Milan. EFLM is the European Region member of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)

External quality assessment

External quality assessment (ex q a) is the challenge of the effectiveness of a laboratories 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 laboratories organisation provides a statement of quality to the laboratory.

Good laboratory practice

In the experimental (non-clinical) research arena, the phrase good laboratory practice or GLP specifically refers to a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of chemical (including pharmaceuticals) non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.GLP was first introduced in New Zealand and Denmark in 1972, and later in the US in 1978 in response to the Industrial BioTest Labs scandal. It was followed a few years later by the Organization for Economic Co-operation and Development (OECD) Principles of GLP in 1992; the OECD has since helped promulgate GLP to many countries.

GLP applies to non-clinical studies conducted for the assessment of the safety or efficacy of chemicals (including pharmaceuticals) to man, animals and the environment.

GLP, a data quality system, should not be confused with standards for laboratory safety - appropriate gloves, glasses & clothing to handle lab materials safely.

The principles of GLP aim to ensure and promote safety, consistency, high quality, and reliability of chemicals in the process of non-clinical and laboratory testing. But, GLP is not limited only to chemicals. It applies to medical devices, food additives, food packaging, colour additives and other non-pharmaceutical products or ingredients as well.

International Federation of Clinical Chemistry and Laboratory Medicine

The International Federation of Clinical Chemistry and Laboratory Medicine or IFCC was founded in 1952 to promote a global vision of clinical chemistry and laboratory medicine worldwide and to be the leading organization in the field. The

organization aims to transcend the boundaries of the field of clinical chemistry and laboratory medicine, to build

professionalism of members worldwide, to disseminate information on ”best practice” at various levels of technology and of economic development, to provide a forum of standardization and traceability, to enhance the scientific level and the quality of diagnosis and therapy for patients.

The IFCC membership comprises 88 national societies and is associated with 5 regional Federations, 49 corporate members and 9 affiliate members representing 45,000 laboratory medicine specialists worldwide.

King Hussein Medical Center

King Hussein Medical Center (Arabic مدينة الحسين الطبية), is a medical compound of five hospitals situated in Amman, Jordan. The center is affiliated to the major Jordanian royal medical services hospitals; also known as JRMS. JRMS has a wide network of hospitals distributed in different provinces across the kingdom of Jordan. And The king Hussein medical center is a major part of JRMS.

Laboratory information management system

A laboratory information management system (LIMS), sometimes referred to as a laboratory information system (LIS) or laboratory management system (LMS), is a software-based solution with features that support a modern laboratory's operations. Key features include—but are not limited to—workflow and data tracking support, flexible architecture, and data exchange interfaces, which fully "support its use in regulated environments". The features and uses of a LIMS have evolved over the years from simple sample tracking to an enterprise resource planning tool that manages multiple aspects of laboratory informatics.

The definition of a LIMS is somewhat controversial: LIMSs are dynamic because the laboratory's requirements are rapidly evolving and different labs often have different needs. Therefore, a working definition of a LIMS ultimately depends on the interpretation by the individuals or groups involved.Historically the LIMS, LIS, and process development execution system (PDES) have all performed similar functions. The term "LIMS" has tended to refer to informatics systems targeted for environmental, research, or commercial analysis such as pharmaceutical or petrochemical work. "LIS" has tended to refer to laboratory informatics systems in the forensics and clinical markets, which often required special case management tools. "PDES" has generally applied to a wider scope, including, for example, virtual manufacturing techniques, while not necessarily integrating with laboratory equipment.

In recent times LIMS functionality has spread even farther beyond its original purpose of sample management. Assay data management, data mining, data analysis, and electronic laboratory notebook (ELN) integration have been added to many LIMS, enabling the realization of translational medicine completely within a single software solution. Additionally, the distinction between LIMS and LIS has blurred, as many LIMS now also fully support comprehensive case-centric clinical data.

Medical laboratory

A medical laboratory or clinical laboratory is a laboratory where clinical pathology tests are carried 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 laboratories that focus on basic science, such as found in some 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 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 volume or complexity.

Medical laboratory scientist

A medical laboratory scientist (MLS), also traditionally referred to as a clinical laboratory scientist (CLS), is a healthcare professional who performs chemical, hematological, immunologic, histopathological, cytopathological, microscopic, and bacteriological diagnostic analyses on body fluids such as blood, urine, sputum, stool, cerebrospinal fluid (CSF), peritoneal fluid, pericardial fluid, and synovial fluid, as well as other specimens. Medical laboratory scientists work in clinical laboratories at hospitals, reference labs, biotechnology labs and non-clinical industrial labs.

Michaela Jaksch-Angerer

Michaela Jaksch-Angerer is a German medical doctor, consultant in laboratory medicine, and Associate Professor (PD Dr. med) for Clinical Chemistry. She holds the position of "Managing and Medical Director" since 2004 at the Freiburg Medical Laboratory Middle East LLC, Dubai, UAE, a member of Synlab since 2013. FML was founded in 2002 as a joint venture of the University of Freiburg Germany and the Al Abbas Group, Dubai, UAE.

Multiplexed point-of-care testing

Multiplexed point-of-care testing (xPOCT) is a more complex form of point-of-care testing (POCT), or bedside testing. Point-of-care testing is designed to provide diagnostic tests at or near the time and place that the patient is admitted. POCT uses the concentrations of analytes to provide the user with information on the physiological state of the patient. An analyte is a substance, chemical or biological, that is being analyzed using a certain instrument. While point-of-care testing is the quantification of one analyte from one in vitro (e.g. blood, plasma or urine) sample, multiplexed point-of-care testing is the simultaneous on-site quantification of various analytes from a single sample.Processing of one biological sample to yield multiple biomarker results allows for POCT testing to be done for patients who may have conditions that require the confirmation of multiple biomarkers and tests before diagnosis (e.g. many types of cancers). xPOCT has important emerging applications in resource-limited settings, (e.g. in the developing countries, in doctor's practices, or at home by non experts) xPOCT has recently become more important for in vitro diagnostics.

National Accreditation Board for Testing and Calibration Laboratories

National Accreditation Board for Testing and Calibration Laboratories (NABL).

National Association of Testing Authorities

The National Association of Testing Authorities, Australia (NATA) was established in 1947 in response to a call for the formation of a national testing services body to ensure the munitions which the government was manufacturing during the Second World War met a sufficiently high standard.

NATA is a private not-for-profit company, governed by a Board that has representation from its members, and from industry, government and professional bodies.

In 1988, NATA's role as an accreditation body was recognised by the Australian Government in a Memorandum of Understanding which was renewed in 2014.

Its head office is situated in Rhodes, New South Wales and it has offices in four other capital cities of Australia. It employs 180 staff and over three thousand volunteer technical experts who assist NATA in the assessment of facilities and on its various technical committees.


PinpointBPS is a methodology for process improvement in laboratories. It is underpinned by eight principles that form the basis for decision-making in a laboratory. While its application is mainly in healthcare — particularly medical laboratories — it has also been applied in other industries. The methodology has been heralded as "groundbreaking" in the field of laboratory performance improvement.

Public health laboratory

Public health laboratories are governmental reference laboratories that protect the public against diseases and other health hazards.

Quality (business)

In business, engineering, and manufacturing, quality has a pragmatic interpretation as the non-inferiority or superiority of something; it's also defined as being suitable for its intended purpose (fitness for purpose) while satisfying customer expectations. Quality is a perceptual, conditional, and somewhat subjective attribute and may be understood differently by different people. Consumers may focus on the specification quality of a product/service, or how it compares to competitors in the marketplace. Producers might measure the conformance quality, or degree to which the product/service was produced correctly. Support personnel may measure quality in the degree that a product is reliable, maintainable, or sustainable.

South African National Accreditation System

SANAS is an acronym for the South African National Accreditation System.

SANAS is recognised by the South African Government in Act 19 of 2006 as the single National Accreditation Body that gives formal recognition that Laboratories, Certification Bodies, Inspection Bodies, Proficiency Testing Scheme Providers and Good Laboratory Practice (GLP) test facilities are competent to carry out specific tasks.

SANAS accreditation certificates are a formal recognition that an organisation is competent to perform specific tasks.

SANAS is responsible for the accreditation of certification bodies for Quality Management Systems and Environmental Management Systems to ISO/IEC 17021(and the IAF interpretation thereof), laboratories (testing and calibration) to ISO/IEC 17025 and medical laboratories to ISO/IEC 17025 and/or ISO 15189 . Inspection Bodies are accredited to ISO/IEC/17020. GLP facilities are inspected for compliance to OECD GLP principles. Verification laboratories are accredited to SANS 10378.

The Dark Report

The Dark Report [1] is a website that provides business intelligence to executive leaders, pathologists, and managers in the laboratory testing industry. It is produced by the DARK Intelligence Group, Inc., a private company that was founded in 1995 with headquarters in Spicewood, Texas, United States.


Viapath is a London-based provider of pathology services jointly owned by Serco, Guy's and St Thomas' NHS Foundation Trust, and King's College Hospital NHS Foundation Trust.

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