The preparation process can take from a few months to a year, depending on the current state of your laboratory and the extent of the necessary changes.
Consulting for the preparation and support of medical laboratory accreditation
accordance with the requirements
of the ISO 15189 standard
Contact for consultation 
Our Experts
Anna Sholomytska
10+ years of experience
Expert in quality management of medical laboratories, expert in the field of verification of research methods, cytomorphologist, head of a medical laboratory, manager of standardization, certification and quality
Oleksandr Chuvakov
22+ years of experience
Expert in quality management of medical laboratories, Medical specialist of Clinical Laboratory Medicine, head of medical institutions
Natalia Shulga
5+ years of experience
Medical Specialist of Clinical Laboratory Medicine, Virology, Microbiology. Consultant at the Consulting Department of Terralab. Expert in Quality Management System ISO 15189:2022. Senior Laboratory Assistant at the Department of Modern Technologies of Medical Diagnostics and Treatment at Bogomolets National Medical University. Junior Scientist at the Research Institute of Experimental and Clinical Medicine
Natalia Fedyunina
15+ years of experience
Bacteriologist, Quality Systems Manager ISO 15189:2022, Consultant at the Consulting Department of TerraLab
Events
Information and Methodical Seminar
Date: 20.06.2025
Time: 13:00-15:30
Format: online
Preparation for accreditation in accordance with ISO 15189:2022 – Opportunities and Life Hacks
Event organizer: TerraLab company
Participants: specialists and experts in medical laboratories
Free. No CPD points
13:00 - 13:10
Welcome speech
13:10 - 13:40
Quality planning – goals and tools
13:40 - 14:10
Digital laboratory: quality control in accordance with ISO 15189:2022 made easy VLKYA automation
14:10 - 14:40
Three steps of a bacteriological laboratory toward accreditation under ISO 15189:2022. Defining internal processes, choosing methods, automating processes
14:40 - 15:10
Overview of the preparation process for accreditation under ISO 15189:2022 – external audit as the key step frank talk about complex matters
15:10 - 15:30
Q&A session
All speakers
About TerraLab
The TerraLab company is a consulting and IT partner for more than 200 medical laboratories in 10 countries with 13 years of project experience in medical laboratories of various directions and forms of ownership.
200+customer laboratories
10countries of the world
14years of experience in the industry
Consulting services for preparation and support of accreditation
- Methodological assistance in developing laboratory management system documents.
- Training laboratory staff on modern principles of quality management for medical laboratories, provisions of ISO 15189:2022 and related standards, CLSI protocols, and recommendations from EFLM, IFCC, EA, and ILAC. Organizing CPD events for medical laboratory professionals.
- Reorganizing laboratory processes in accordance with ISO 15189:2022, including support for method verification and validation, establishment of internal quality control (IQC) and external quality assessment (EQA) processes.
- Preparing and completing the necessary set of documents for the accreditation of a medical laboratory in compliance with ISO 15189:2022 requirements at the National Accreditation Agency of Ukraine, supporting corrective actions following document remarks and during on-site evaluations by NAAU.
- Organizing internal audits in the laboratory, conducting trial audits of the laboratory management system for compliance with ISO 15189:2022 standard requirements.
Why us?
Experts-practitioners
We have leading modern approaches to the organization of laboratory processes and, we love what we do.
Results orientation
It is important to us to help you implement the changes, not just to get the certificate.
Individual approach
A special approach to each laboratory based on your plans and goals.
Professionalism
Professional IT tools for the internal quality system that will make complex processes simple.
FAQs
In this section you will find answers to the most frequently asked questions about our services and terms of service.
Ask your questionHow long does the process of preparing a medical laboratory for accreditation take?
What documents are required for medical laboratory accreditation?
Laboratory Accreditation Documentation Requirements
- Statutory documents of the institution, duly certified
- Draft scope of accreditation
- Key quality management system documents:
Declaration of impartiality
Declaration of confidentiality assurance
Quality Policy
Quality Objectives
Quality system procedures
Copies of test results (protocols) for each area of activity
- Medical laboratory passport
- Structural and organizational documents, such as:
Laboratory regulations
Data on the location of the applicant's premises in the city
Floor plan of the medical laboratory/center and adjacent premises with equipment layout
Copies of diplomas or other documents confirming the qualifications of personnel according to Form 6 of the Medical Laboratory/Center Passport
- Method validation data
Copy of the Articles of Association of the legal entity
Copy of the Extract from the Unified State Register
Copy of the Value Added Tax Registration Certificate, or Extract from the Register of Value Added Tax/Unified Tax Payers, or other document confirming the taxation system under which the applicant operates
Copies of the approved organizational structure of the legal entity and staffing schedule
Do we provide consultations after obtaining accreditation?
After obtaining accreditation, the laboratory's task is not only to maintain the achieved level but also to improve processes. This path should be continuous and controlled. Therefore, we provide consultations on maintaining and improving your laboratory's quality management system.
For expanding the scope of accreditation, our team can provide services for re-preparation for accreditation.