Public health laboratories are governmental reference laboratories that protect the public against diseases and other health hazards.
In 2007, Haim Hacham et al. published a paper addressing the need for and the process of international standardised accreditation for laboratory proficiency in Israel. Their practice is an invaluable experience for all in the sector.With similar efforts, both the Japan Accreditation Board for Conformity Assessment (JAB) and the European Communities Confederation of Clinical Chemistry and Laboratory Medicine (EC4) have validated and convened ISO 15189, respectively ,. However, Spitzenberger and Edelhäuser have expressed their concerns in that ISO accreditation may include obstacles rising from new emerging medical devices and the new approach of assessment, indicating the time dependence of the standards.
The Public Health Laboratory Service was established as part of the National Health Service in 1946. An Emergency Public Health Laboratory Service was established in 1940 as a response to the threat of bacteriological warfare. There was originally a central laboratory at Colindale and a network of regional and local laboratories. By 1955 there were about 1000 staff. These laboratories were primarily preventive with an epidemiological focus. They were, however, in some places located with hospital laboratories which had a diagnostic focus.
It was replaced by the Health Protection Agency in 2003.
The ISO 9000 family of quality management systems (QMS) is a set of standards that helps organizations ensure they meet customers and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of quality management systems, 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 fulfil.
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers; which ISO 9000 defines as "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention in quality assurance differs subtly from defect detection and rejection in quality control and has been referred to as a shift left since it focuses on quality earlier in the process.
Accreditation is the process in which certification of competency, authority, or credibility is presented.
In the experimental (non-clinical) research arena, good laboratory practice or GLP is a quality system of management controls for research laboratories and organizations to ensure the uniformity, consistency, reliability, reproducibility, quality, and integrity of products in development for human or animal health through non-clinical safety tests; from physio-chemical properties through acute to chronic toxicity tests.
ISO/IEC 17025General requirements for the competence of testing and calibration laboratories is the main ISO 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 the International Organization for Standardization 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.
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 International Federation of Clinical Chemistry and Laboratory Medicine or IFCC is a global organization that promotes the fields of clinical chemistry and laboratory medicine. It was established in 1952 as the International Association of Clinical Biochemists to organize the various national societies of these fields. 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 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.
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.
SANAS is an acronym for the South African National Accreditation System.
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.
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.
BRT Laboratories, Inc. is a Baltimore, Maryland-based biotechnology company that performs DNA testing. The company has three divisions: Relationship Testing, Forensics, and Clinical Services. It is a privately held, wholly owned subsidiary of Baltimore RH Typing Laboratory, Inc.
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 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.
National Accreditation Board for Testing and Calibration Laboratories (NABL).
Sundaram Medical Foundation is a community-centered, Non-Profit, trust hospital founded in 1994 by Dr. Rangarajan. Sundaram Medical Foundation offers multi-specialty medical care, including 24-hour ambulance service and emergency room facilities, and specialities such as General Medicine, General Surgery, Pediatrics, Obstetrics and Gynecology, ENT, Ophthalmology, Dermatology, Dental, Family Medicine, Orthopedics and Psychiatry.
The National Association of Testing Authorities, Australia (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.
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.
United States laboratory networks and organizations