Simulate your laboratory's accreditation for free. Then buy only what you need.

A complete ISO 15189:2022 document system for medical laboratories — 184 policies, procedures and SOPs across five disciplines, in English and Georgian. Developed by ASF, adapted to Georgian requirements by PHIG, personalized for your laboratory, and designed to guide you from preparation through to the accreditation body's assessment.

ISO 15189 is the international standard for medical laboratories — quality and competence together. Unlike ISO 9001, it is not a management-system certification but an accreditation: a national accreditation body assesses the laboratory’s technical competence, its impartiality, its specimen pathway from patient preparation to reporting, its equipment and metrological traceability, its internal quality control and external quality assessment, its validation of methods and its management of laboratory information. It is the standard that insurers, hospitals and referring clinicians increasingly require of any laboratory whose results they rely on, and the one that makes a laboratory’s results portable across borders.

The 2022 edition asks for a documented system that reaches into every bench: policies, procedures and standard operating procedures for every step of the pre-examination, examination and post-examination process, section by section. That is more than 180 controlled documents — policies, procedures, SOPs, forms, registers, matrices and job descriptions — for a general laboratory before an assessor can begin. ASF wrote them once — in English, adapted to Georgia by the Public Health Institute of Georgia — and built the machinery to turn the library into your laboratory’s system in seconds, with your section heads named in every SOP.

Start with the Simulation, free. Twenty minutes, no login. Your disciplines first — biochemistry, hematology, coagulation, immunology, urinalysis — then one question per clause of ISO 15189:2022. At the end: your readiness by clause, the exact documents your laboratory needs, the courses and who attends, the cost line by line, your own staff’s hours by role, and the weeks to the accreditation assessment. If the numbers say not now, you have lost nothing and gained a plan.

Run the Simulation — free

Fifteen groups, following the structure of the standard — governance, management requirements, personnel, equipment and reagents, facilities and suppliers, the pre-examination specimen pathway, general analytical examination, safety and IT, discipline-specific examination, post-examination general and discipline-specific — and then the working tier: the forms every SOP produces, the registers (documents, SOPs, incidents, risks), the matrices (authorization, risk, retention) and ten job descriptions from Laboratory Director to Equipment Custodian.

153 documents are universal — every laboratory receives them. The rest belong to a discipline module and are included only when the section exists: Clinical biochemistry (8), Hematology (7), Coagulation (6), Immunology / immunoassay (5), Urinalysis (5).

What the market charges — quoted. Generic ISO 15189 toolkits from international template vendors: €500–1,200, English only, not discipline-specific, typically under fifty documents. Laboratory consultants writing the system by hand: €5,000–15,000 depending on the number of sections, over six to twelve months. None is bilingual; none is adapted to Georgian law; none contains section SOPs for five disciplines written by laboratory professionals.

Written by laboratory professionals and health managers. The system was prepared by clinical laboratory specialists, quality managers and physicians with working experience of laboratory accreditation, quality control and hospital management. Developed by ASF in English; made Georgian by the Public Health Institute of Georgia — adapted, not translated, to Georgian legislation, the licensing regime and the Georgian Accreditation Centre’s requirements, so that each Georgian document states the law it follows. Trainings delivered in Georgia carry dual certificates, ASF and PHIG.

Independent from everything else ASF does. ISO 15189 Ready is a separate product from ISO 9001 Ready and from ASF healthcare accreditation; buying one has no bearing on the others. A laboratory inside a hospital or clinic that already holds ASF accreditation or ISO 9001 Ready will find the governance documents familiar — document control, audit, management review, CAPA — but the ISO 15189 system is complete on its own and stands alone for an independent laboratory. ASF will never grant ISO 15189 accreditation: that is the national accreditation body’s decision, after its own assessment, and ASF’s role stops at readiness.

Everything after the documents is optional. Courses €29 each, €390 for all sixteen, unlimited staff. Pre-assessment, readiness assessment, consultancy sessions, helpdesk, annual maintenance and the QMS platform are quoted once your laboratory’s scope is confirmed — see Consultancy or request a quote directly.

Six things that are true because they are built into the product, not because we say so.

Every step above is a real, working tool you can open right now — not a PDF to request. Verified live as of this page's last update.

Run the Simulation

Twenty minutes, free, no login. Your disciplines first; then only your pathway — with every price, every hour and the calendar.

Start

Each course covers the ISO 15189:2022 management requirements that correspond to the SOPs in this document system. Courses are available in English and Georgian. All include interactive lessons, case studies, and a 15-question certificate exam.