For each standard below, the program carries its list of requirements on its «Accreditation and quality» screen, shows the evidence it provides for each one, and marks what remains the laboratory's own work. This list is the one inside the program, by name and edition.
College of American Pathologists
Laboratory Accreditation Program checklists -- the requirements cited publicly
Requirements the laboratory reviews in the program: 333
Built from what the body publishes openly, so it holds part of the standard. The program says so beside it.
International Organization for Standardization
Medical laboratories: requirements for quality and competence
Edition: 2022
Requirements the laboratory reviews in the program: 123
Joint Commission International
Accreditation standards for laboratories, 4th edition (effective 2022-01-01)
Edition: 4
Requirements the laboratory reviews in the program: 195
WHO Regional Office for Africa, with the African Society for Laboratory Medicine (ASLM)
SLIPTA checklist, version 3 (2023-12-22): the stepwise way towards ISO 15189, scored in stars
Edition: 3:2023
Requirements the laboratory reviews in the program: 151
Dubai Health Authority, Health Regulation Sector
Every clinical laboratory licensed by DHA in the Emirate of Dubai (effective 27-05-2023)
Edition: HP-12 issue 5.1
Requirements the laboratory reviews in the program: 16
Dubai Health Authority, Health Regulation Sector
Every DHA-licensed health facility and professional providing clinical laboratory services in the Emirate of Dubai (effective 17-07-2023, revision due 17-05-2028)
Edition: ST-28 issue 2
Requirements the laboratory reviews in the program: 207
Australian Commission on Safety and Quality in Health Care
National Pathology Standards, first edition (in force July 2027)
Edition: 2027
Requirements the laboratory reviews in the program: 88
SNA-DICQ, Sistema Nacional de Acreditação (Sociedade Brasileira de Análises Clínicas)
Voluntary accreditation of the quality management system of clinical laboratories in Brazil
Edition: 8ª edição (2023)
Requirements the laboratory reviews in the program: 134
Brazilian Society of Clinical Pathology/Laboratory Medicine (SBPC/ML), Clinical Laboratory Accreditation Programme
Voluntary accreditation of clinical laboratories and their collection units in Brazil (the programme holds ISQua's recognition)
Edition: 2025
Requirements the laboratory reviews in the program: 252
ANVISA (Brazilian Health Regulatory Agency)
The services that perform clinical laboratory examinations, public or private: RDC 978 of 06-06-2025, as amended by RDC 1043 of 01-10-2026
Edition: 2025
Requirements the laboratory reviews in the program: 124
Ministry of Health (Chile); accreditation run by the Superintendencia de Salud
Clinical laboratories in Chile; accreditation is required to serve patients under the GES guarantees
Edition: DE 37/2010
Requirements the laboratory reviews in the program: 86
German Medical Association (Bundesärztekammer)
Quantitative examinations: limits of internal and external quality control (Part B 1)
Edition: 2023
Quality-control limits for 116 measured analytes: once the laboratory follows it, every control measurement of those tests is judged against them
General Authority for Healthcare Accreditation and Regulation
Clinical laboratory accreditation standards
Edition: 2025
Requirements the laboratory reviews in the program: 482
Cofrac (Comité français d'accréditation), section Santé humaine
Medical biology laboratories and pathology structures in France, over ISO 15189:2022 (in application from 01-10-2023)
Edition: révision 08
Additional requirements on top of ISO 15189: 50
National Accreditation Board for Testing and Calibration Laboratories (NABL)
Medical laboratories in India seeking NABL accreditation, over ISO 15189:2022 (in force by 31-12-2025)
Edition: Issue 01 (18-12-2024)
Additional requirements on top of ISO 15189: 116
Health Care Accreditation Council (Jordan)
Medical Laboratories Accreditation Standards, built on the WHO LQSI tool
Built from what the body publishes openly, so it holds part of the standard. The program says so beside it.
Ministry of Health (Morocco)
Guide to the good performance of medical biology examinations, arrêté 2598-10 under law 12-01 (in force twelve months after its publication of 18-11-2010)
Edition: 2010
Requirements the laboratory reviews in the program: 65
Secretaría de Salud (Mexico)
Every clinical laboratory in Mexico, public, social and private; enforced by the Secretaría de Salud and the states (DOF 27-03-2012)
Edition: 2011
Requirements the laboratory reviews in the program: 68
Ministry of Health (Oman), Directorate General of Private Health Establishments
Every private medical laboratory in Oman; checked by the Directorate's audits (document MoH/DGPHE/GUD/003, approved 19-03-2023, review every four years)
Edition: 2023
Requirements the laboratory reviews in the program: 129
Saudi Central Board for Accreditation of Healthcare Institutions
National Standards for Clinical Laboratories and Blood Banks, first edition (effective 2016-01-01)
Edition: 2015
Requirements the laboratory reviews in the program: 128
Ministry of Health (Türkiye), Department of Health Efficiency, Quality and Accreditation; TÜSKA (TÜSEB) accredits
Voluntary accreditation of laboratories in Türkiye; the laboratory set of the Health Accreditation Standards (SAS)
Edition: Laboratuvar Seti v2.1/2020
Requirements the laboratory reviews in the program: 150
Centers for Medicare & Medicaid Services (CMS)
Proficiency testing: criteria for acceptable performance (42 CFR 493, Subpart I)
Edition: 42 CFR 493 (2026-10-07)
Quality-control limits for 105 measured analytes: once the laboratory follows it, every control measurement of those tests is judged against them
On «Accreditation and quality», the laboratory chooses the standards it follows, with the reason written down.
«Accreditation readiness» shows, for each requirement, the record the program keeps for it, and what is left for the laboratory to do.
Print the readiness report for the assessor: each requirement with its evidence, under the standard's own name and number.
Write to us with its name and the body that issues it. Every laboratory can still work by ISO 15189, which the program carries.
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