T 65v22 - E-Learning - ISO 15189 management of a medical biology laboratory version 2022
Mastering the management of a medical biology laboratory (MBL) is essential for ensuring patient safety and optimizing operational processes. This ISO 15189 online course offers a comprehensive, flexible e-learning solution to structure your approach to improving sample collection, analysis, and result reporting in accordance with the 2022 version of the standard. By choosing this course (reference T 65v22), you will understand and internalize the requirements and specificities of the ISO 15189 standard. This approach enables you to boost confidence among patients and healthcare professionals while enjoying an immediate financial benefit: a saving of 54 euros on the set of documents included in the training.
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See the online game G 30 IZOGOOD® 15189 Decrypt the ISO 15189 standard while having fun soon See the online course T 50v22 ISO 15189 Internal audit soon See the online training package T 90v22 ISO 15189 soon Example of a certificate upon completion of training |
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| Result of the training satisfaction survey : | 83% | Last update on September 17, 2026 |
Description of the online course for your medical biology laboratory management system ISO 15189 version 2022
This online ISO 15189 training course is designed to support businesses and professionals in understanding, preparing, implementing and improving a medical biology laboratory management system compliant with the 2022 version of the standard. It enables better integration of quality and regulatory requirements into the laboratory's activities and ensures that actions are guided by a logic of quality, competence, compliance, control and continual improvement.
Free quiz without registration on the requirements of the ISO 15189 standard that you can exercise by clicking on the "QUIZ" button:
Discover the ISO 15189 standard and
- its contents
- its principles
- its requirements
- its stakes
Become familiar with the fundamentals of the ISO 15189 medical laboratory approach
- process approach
- medical laboratory terminology
- readiness documents
- internal audit documents
- risk approach
- improvement
- readiness for ISO 15189 accreditation
- feedback
The important and fundamental elements of a medical laboratory management system
- quality approach (quality management principles, PDCA cycle)
- standards and definitions
- process approach (process types, mapping)
- specific requirements (impartiality, confidentiality)
- structure and governance
- risks and opportunities
- resources (facilities, equipment, calibration, reagents, contracts)
- processes (exalination, complaints, continuity)
- management system (documentation, management review)
- POCT (Point-of-Care-Testing)
This framework helps to understand how ISO 15189 fits into the overall activities of the laboratory. It also helps to better manage activities, strengthen regulatory compliance, and make the management system a true driver of reliability, safety and performance.
The menu of the course
- Presentation
- MCT (multiple-choice test) Beginning (10 questions)
- 1 Medical biology laboratory (MBL)
- 1.1 History
- 1.2 Scope
- 1.3 Benefits
- 1.4 Principles and steps
- 2 Definitions, standards and books
- 2.1 Definitions
- 2.2 Standards
- 2.3 Books
- MCT MBL (7 questions)
- 3 Process approach
- 3.1 Types of processes
- 3.2 Process mapping
- 3.3 Process approach
- MCT Process approach (7 questions)
- 4 General requirements
- 4.1 Impartiality
- 4.2 Confidentiality
- 4.3 Patient requirements
- Case Customer and needs
- Summary of clause 4
- MCT General requirements (8 questions)
- 5 Structure and governance
- 5.1 Legal entity
- 5.2 Laboratory director
- 5.3 Laboratory activities
- 5.4 Structure and authority
- 5.5 Policy and objectives
- 5.6 Risk management
- Case Quality policy
- Case Communication
- Summary of clause 5
- MCT Structure and governance (8 questions)
- 6 Resources
- 6.1 General
- 6.2 Personnel
- 6.3 Facilities
- 6.4 Equipment
- 6.5 Calibration and traceability
- 6.6 Reagents and consumables
- 6.7 Contracts
- 6.8 External providers
- Case Importance of work
- Case Supplier selection
- Summary of clause 6
- MCT Resources (7 questions)
- 7 Processes
- 7.1 Process requirements
- 7.2 Pre-examination processes
- 7.3 Examination processes
- 7.4 Post-examination processes
- 7.5 Nonconforming work
- 7.6 Data control
- 7.7 Complaints
- 7.8 Business continuity
- Case Acceptance criteria
- Summary of clause 7
- MCT Processes (8 questions)
- 8 Management system
- 8.1 General requirements
- 8.2 Documentation
- 8.3 Document control
- 8.4 Record control
- 8.5 Actions to address risks
- 8.6 Improvement
- 8.7 Nonconformities
- 8.8 Evaluations
- 8.9 Management review
- Case Document control
- Case New risk
- Case Risk register
- Case Risk treatment
- Case Task priority
- Case Nonconformities
- Case Kaizen & problem-solving
- Case Audit preparation
- Case Auditor question
- Case Audit program
- Case Audit report
- Case Management review
- Summary of clause 8
- MCT Management system (7 questions)
- Annex A POCT
- Summary of Annex A
- MCT POCT (8 questions)
- MCT End (20 questions)
Read more about the online course ISO 15189 version 2022
Master the management of a medical biology laboratory (ISO 15189 accreditation) in order to:
• understand and assimilate the requirements and specificities of the ISO 15189 standard
• build patient confidence and optimize operational processes
• improve sample collection, analysis and the reporting of results
What is the ISO 15189 standard?
It is the international benchmark standard establishing requirements for impartiality, competence, and quality specific to medical biology laboratories (MBLs). It serves as the foundation for laboratory accreditation by national bodies (such as COFRAC in France or BELAC in Belgium).
What is the major difference between the 2012 and 2022 versions?
The 2022 version introduces three fundamental changes:
- risk-based approach: primarily focused on patient safety and clinical risk
- integration of POCT (Annex A): the former ISO 22870 standard on point-of-care testing is directly integrated into ISO 15189
- harmonized structure (HLS): alignment with the ISO/IEC 17025 standard (general, structural, resource, process, and management requirements).
What is the difference between method verification (§ 7.3.2) and validation (§ 7.3.3)?
verification: applies to standardized, commercially available methods. The laboratory demonstrates that it achieves the performance levels (trueness, precision) stated by the manufacturer in its own setting
validation: applies to modified methods, in-house developed methods, or methods used outside their intended scope. It requires a comprehensive scientific demonstration of all method characteristics
How should Point-of-Care Testing (POCT / Annex A) be managed?
Even if the examination is performed at the patient's bedside by a nurse or physician, the laboratory remains solely responsible for technical and medical aspects. It must:
- train and specifically authorize users
- implement a digital lock on analyzers requiring a badge or password
- automate the blocking of devices if Internal Quality Control (IQC) fails
How often must the management review (§ 8.9) be conducted?
The standard requires "planned intervals." Standard practice is to conduct at least one per year.
What is the difference between a Correction and Corrective Action (§ 8.7)?
correction: immediate action to stop the problem (e.g., discarding a batch of defective reagents and re-running the test series)
corrective action: root cause analysis to implement permanent safeguards and prevent the anomaly from recurring in the future
Who uses ISO 15189?
Medical laboratories involved in patient care—including hospitals, clinics, and diagnostic laboratories—use ISO 15189 to demonstrate their competence and improve the quality of their testing processes.
What are the main objectives of ISO 15189?
- ensure the quality and reliability of medical examination results
- improve patient safety and satisfaction
- promote continual improvement of laboratory processes
- standardize procedures and ensure consistency
What does the ISO 15189 standard cover?
It covers management requirements (e.g., document control, quality management system, personnel competence) and technical requirements (e.g., sample handling, equipment calibration, method validation, report generation).
How does a laboratory obtain ISO 15189 accreditation?
A laboratory must implement the requirements of the ISO 15189 standard, undergo internal audits, and then be assessed by an accredited certification body. This body evaluates the laboratory's management system and technical competence before granting accreditation.
How does the ISO 15189 standard benefit patients?
It ensures the accuracy and reliability of laboratory results, which directly impacts diagnosis, treatment, and patient safety.
What is the difference between ISO 15189 and other standards like ISO 9001?
ISO 15189 is specifically designed for medical laboratories and includes requirements for technical testing, whereas ISO 9001 is a general quality management standard applicable to any organization.
Notions of ISO 15189:2022
Any person involved in the preparation and implementation of a medical laboratory management system:
- laboratory director
- quality director
- quality manager
- biologist
- metrology manager
- safety manager
- maintenance manager
- project leader
- technician
- operator
- quality correspondent
- quality technician
- quality assistant
- quality operator
- internal auditor
- student
14 hours online on average (according to knowledge and aptitudes, this duration can vary individually). One hour of online training is equivalent to at least 2 hours of training on the spot.
At the end of the module, you will be able to:
- interpret the requirements of the ISO 15189 standard
- take part in the development of the policies and objectives
- take part in the implementation of the document system
- understand and implement the 7 quality management principles
- evaluate the ISO 15189 accreditation project
- be familair with the steps and tools for implementation of your management system
Methods and tools
- dedicated Internet site
- specific online training module
- Open and Distance Learning (ODL)
- your training history:
- the time you have passed on each clause and sub-clause of the module
- the record of the score of all your trials of the MCTs (multiple-choice tests)
- level test at beginning of the training
- MCTs with comments, notes on a 20 point scale and recommendations
- videos
- true stories
- good practices
- bad practices
- case studies
- jokes
- games
- online tutorial :
- a follow up of acquired material and the progress of each trainee
- online or by e-mail within 24 hours
- personalized answers to questions
- advice and recommendations about documents, books and useful links
- delivered certificate of attendance and mastery at the end of the training (example)
Access to the course is 60 days from the date of validation of your order. This period will be renewed for free upon a simple request within 6 months
Test your knowledge of the requirements of ISO 15189 version 2022 in relation to the clauses and sub-clauses of the standard by answering online the questions of the:
The requirements of the ISO 15189 standard version 2022 are:
ISO 15189 Explained | Medical Laboratory Accreditation Made Simple | QualityPulse #11 10' 34"
Stago Education Talk: ISO 15189:2022 – What Your Lab Needs to Know for a Smooth Transition 25' 50"
Navigating ISO 15189: A Blueprint for Quality in Medical Laboratories 33' 14"
What is new in latest version of ISO 15189:2022 | Transition from ISO 15189:2012 to ISO 15189:2022 37' 17"
Webinar | ISO 15189 Accreditation requirements for Medical Labs 40' 02"
ISO 15189:2022 Medical laboratories – Requirements for quality and competence 48' 34"
Importance of the ISO 15189 Quality Management System 57' 07"
BS EN ISO 15189 – Quality Management in Laboratories webinar 58' 51"
ISO 15189 2022 Overview (Part One) 59' 59"
Foundations of Laboratory Quality Management Systems (LQMS) & ISO 15189:2022 Updates 1h 43' 15"
Here is a MCT (Multiple-choice test) to evaluate, before beginning, the level of your knowledge for this course. (One or more correct answers are possible). You can start again as many times you wish.
1. The first edition of the ISO 15189 standard was published in:
2. A process creates, among other things:
3. The requirements of ISO 15189 version 2022 are:
4. What should a staff member do when a conflict of interest is suspected?
5. Example of a requirement regarding the laboratory's legal entity status:
6. What is the requirement regarding personnel performing specific technical activities?
7. What shall the laboratory do if a received sample is nonconforming?
8. What action is required upon detection of an anomaly in the examination process?
9. What obligation applies to the laboratory regarding document control?
10. Who bears ultimate responsibility for the quality and technical validity of point-of-care testing (POCT) results?
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