ISO 15189 Ready · Training

Training — 16 courses, each tied to the SOPs it covers

Eleven courses every laboratory needs, five that appear only when the discipline exists — nothing hidden, nothing generic

E-learning by default · one price per laboratory, unlimited staff · certificate with QR into the ASF Passport · dual ASF–PHIG certificates in Georgia

The line that never moves. ASF prepares medical laboratories for ISO 15189. ASF does not accredit them. ISO 15189 accreditation is granted by a national accreditation body — in Georgia the Georgian Accreditation Centre; elsewhere the ILAC-recognised body of your country — after its own assessment. ASF takes no commission and recommends none. ISO 15189 Ready is a separate product from ISO 9001 Ready and from ASF healthcare accreditation.

Universal courses — every laboratory

Eleven courses. Open any outline.

Code	Course	Who attends	Length	Mode	Documents covered	Assessment
L-01	ISO 15189:2022 for the laboratory director and quality manager Outline · ISO 15189 clauses 4–8 overview; 4 impartiality and confidentiality; 5 structure and governance; 8 management system The shape of the standard and what an assessor from the accreditation body will look for: impartiality and confidentiality as requirements with evidence, not statements; the laboratory director's responsibilities; the structure of clauses 6 (resources), 7 (process) and 8 (management system); the two routes to the management system (option A, the clauses; option B, ISO 9001); risk-based thinking applied to the specimen pathway; what the document set contains and how every policy, procedure and SOP maps to a clause. Outcome: the director and quality manager can present the laboratory's system to an assessor clause by clause.	Laboratory director, quality manager, section heads	60 min	E-learning	P-01–P-07, P-24, PR-01–PR-06	Quiz
L-02	Personnel competence, training and health Outline · ISO 15189 clauses 6.2 personnel Job descriptions and authorisations; the competence assessment procedure — direct observation, record review, blind samples, problem-solving — and its documentation; training plans, delivery and attendance; immunisation, exposure management and occupational health; awareness of impartiality and confidentiality for every employee. One competence record completed for a real analyst. Outcome: every staff member has a current, evidenced competence file.	Quality manager, section heads, all staff for the awareness part	45 min	E-learning	P-08, P-09, P-31, PR-07, PR-08, SOP-HR-01–04	Quiz + competence record exercise
L-03	Internal audit, nonconformity, CAPA and management review Outline · ISO 15189 clauses 8.7 nonconformities, 8.8 internal audit, 8.9 management review Planning an audit programme that covers every clause and section yearly; auditing a section from its SOPs; nonconforming work — hold, release and the decision about results already reported; root cause and CAPA with verification; management review inputs specific to a laboratory (EQA performance, turnaround time, complaints, supplier performance, risks) and recorded outputs. Live mock audit of one section of the training laboratory. Outcome: trained internal auditors and a management review that would satisfy an assessor.	Quality manager, internal auditors, laboratory director	3 h	Live online workshop + graded mock audit	P-05, P-06, P-07, PR-04, PR-05, PR-06, SOP-21	Mock audit graded by ASF
L-04	Pre-examination — patient preparation, collection, identification, transport, reception Outline · ISO 15189 clauses 7.2 pre-examination processes Patient preparation and the request; collection by tube type and order of draw; labelling at the bedside with two identifiers; packaging and transport temperatures and times; reception, acceptance and the rejection criteria; pre-analytical storage, centrifugation, aliquoting and secondary labelling; chain of custody where required; patient identification and record correlation. Outcome: the specimen pathway is performed and documented so that no result is issued on a doubtful specimen.	Phlebotomists, nurses, reception, specimen reception staff	60 min	E-learning + observed collection	P-16, P-17, PR-17, PR-18, SOP-PA-01–12, SOP-20	Quiz + observed venepuncture and labelling
L-05	Equipment, calibration, maintenance and environment Outline · ISO 15189 clauses 6.3 facilities and environment, 6.4 equipment, 6.5 calibration and metrological traceability, 6.6 reagents and consumables Equipment selection, acceptance and inventory; calibration with metrological traceability and the calibration log; scheduled maintenance; breakdown, troubleshooting and decommissioning; reagent and calibrator receipt, storage and lot verification; temperature and humidity monitoring; cleaning and disinfection; supplier evaluation. Outcome: every instrument has a complete record from acceptance to decommissioning.	Section heads, analysts, maintenance and cleaning staff	60 min	E-learning	P-18–P-21, P-34, PR-09–PR-13, SOP-EQ-01–06, SOP-ENV-01, SOP-A-05, SOP-A-09	Quiz + calibration log exercise
L-06	Method verification, validation and measurement uncertainty Outline · ISO 15189 clauses 7.3.3 verification, 7.3.4 validation, 7.3.5 measurement uncertainty The difference between verifying a manufacturer's claim and validating an in-house or modified method; the parameters — precision, trueness, linearity, reference intervals, carry-over; acceptance criteria and the report; measurement uncertainty from IQC data and its use in interpreting results; re-verification after a method or reagent change. One verification study calculated from a supplied data set. Outcome: the laboratory can produce a verification file an assessor accepts for every test.	Section heads, senior analysts, quality manager	90 min	E-learning + worked data set	P-36, SOP-A-01, SOP-A-02, SOP40-MU, SOP-BIO-08	Quiz + one verification study on a supplied data set
L-07	Internal quality control, Westgard rules and EQA Outline · ISO 15189 clauses 7.3.7 ensuring validity — IQC and EQA Two-level IQC before patient results; Levey-Jennings charts and the Westgard rules; what to do on a rule violation — stop, investigate, correct, re-run affected samples; QC material receipt, storage and lot change; EQA participation, result analysis and corrective action on unsatisfactory performance; when no EQA scheme exists. Outcome: analysts apply the rules and the laboratory acts on every failure.	All analysts, section heads, quality manager	60 min	E-learning + QC exercise	P-37, PR-23, SOP-A-03, SOP-A-04, SOP-QC-01, SOP-QC-02, SOP-23	Quiz + Levey-Jennings interpretation exercise
L-08	Post-examination — validation, authorization, critical results, amendment Outline · ISO 15189 clauses 7.4 post-examination processes, 7.4.1 review and release, critical results Technical validation and result review, delta checks and reflex testing; authorisation and who may authorise; the report content the standard requires; turnaround time monitoring; the critical-value list, the notification within the defined time, read-back and documentation, escalation when the clinician cannot be reached; amendment and re-release with the audit trail. Outcome: results leave the laboratory validated, authorised, on time, and critical values reach a clinician with proof.	Analysts authorising results, section heads, reception	60 min	E-learning	P-38–P-40, P-42, PR-22, PR-32, SOP-18, SOP-19, SOP-PO-01–03, SOP-PO-05, SOP-PO-07	Quiz + critical-value read-back exercise
L-09	Biosafety, PPE, spills, sharps, waste, fire, access Outline · ISO 15189 clauses 6.3 facilities, safety; incident management Biosafety levels and standard precautions in the laboratory; PPE selection and use; spill management for biological and chemical spills; sharps and the post-exposure pathway; biological and medical waste segregation; fire safety instructions; access control to testing areas; incident and accident notification and registration. Outcome: every staff member knows the procedure for the five emergencies of a laboratory.	All laboratory staff, cleaning staff	45 min	E-learning + drill	P-12, P-14, P-15, P-28, P-30, PR-16, SOP-SF-01–07, SOP-AC-01	Quiz + spill drill attendance
L-10	Information security, LIS downtime, backup, data protection Outline · ISO 15189 clauses 7.6 management of laboratory information; 4.2 confidentiality Passwords, access and logging; data protection and confidentiality obligations; the LIS downtime procedure — manual mode, recovery and records; backup and restore testing; data integrity and audit trails; breach reporting. Outcome: results are protected and the laboratory can keep working and recover when the LIS fails.	IT lead, quality manager, all users of the LIS	45 min	E-learning	P-10, P-11, P-43, SOP-31, SOP-32, SOP-IT-01	Quiz + downtime exercise
L-16	Clients, complaints, referral laboratories and agreements Outline · ISO 15189 clauses 4.1 impartiality; 7.1 agreements; 7.5 referral; 8.6 complaints; 7.4 communication Service agreements and their review; customer communication; complaint intake, investigation and response with timelines; client feedback and satisfaction; selection and monitoring of referral laboratories and control of their results; supplier evaluation. Outcome: every agreement, referral and complaint is handled and recorded by the procedure.	Reception, client services, quality manager, laboratory director	45 min	E-learning	P-22, P-23, P-25, PR-29, SOP-CUST-01–04, SOP-PO-06	Quiz + worked complaint

Discipline courses — only when the section exists

Five courses. Tick biochemistry in the Simulation and L-11 appears in your list.

Code	Course	Who attends	Length	Mode	Documents covered	Assessment
L-11	Clinical biochemistry section Outline · ISO 15189 clauses 7.3 examination processes — biochemistry Analyzer operation and daily maintenance; the routine testing process; section IQC and EQA; reagent and calibrator receipt and lot verification; equipment maintenance and malfunction; method or reagent change verification; result review with delta checks and reflex actions. Outcome: the section runs its SOPs and keeps the records the assessor samples.	Biochemistry analysts and section head	60 min	E-learning	SOP-BIO-01–08	Quiz
L-12	Hematology section Outline · ISO 15189 clauses 7.3 examination processes — hematology Analyzer operation and daily maintenance; CBC performance and authorisation; section IQC and EQA; peripheral blood smear preparation, staining and microscopy; the pathological-results confirmation and reflex algorithm; hematology critical results. Outcome: the section runs its SOPs and confirms pathological results by the algorithm.	Hematology analysts and section head	60 min	E-learning	SOP-HEM-01–07	Quiz + smear exercise
L-13	Coagulation section Outline · ISO 15189 clauses 7.3 examination processes — coagulation Analyzer operation and daily maintenance; PT/INR, APTT and core tests; section IQC and EQA; citrate-tube acceptance and rejection criteria; coagulation critical results notification. Outcome: the section runs its SOPs with the specimen criteria applied every time.	Coagulation analysts and section head	45 min	E-learning	SOP-COAG-01–06	Quiz
L-14	Immunology section Outline · ISO 15189 clauses 7.3 examination processes — immunology Immunoassay routine process; section IQC and EQA; reagent and calibrator lot verification and calibration; result review, reporting and interpretive comments. Outcome: the section runs its SOPs and reports with the interpretive comments the standard expects.	Immunology analysts and section head	45 min	E-learning	SOP-IMM-01–05	Quiz
L-15	Urinalysis section Outline · ISO 15189 clauses 7.3 examination processes — urinalysis Test-strip performance and recording; urine sediment microscopy and reporting; section IQC; specimen acceptance and rejection; result review and critical pathological findings. Outcome: the section runs its SOPs and manages critical findings.	Urinalysis staff and section head	45 min	E-learning + microscopy exercise	SOP-UR-01–05	Quiz

Delivered through the ASF Academy, an affiliated venture disclosed under the Independence and Non-Influence Statement. €29 per course, €390 for all sixteen, per laboratory, unlimited staff. Learning has no bearing on any accreditation decision.

See which courses your laboratory needs

The Simulation lists them for your disciplines, with the documents and the cost.

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ISO 15189 Ready — Training: the 16 Courses

Training — 16 courses, each tied to the SOPs it covers

Universal courses — every laboratory

Discipline courses — only when the section exists

See which courses your laboratory needs