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Medical lawyer. Specializes in protecting the rights of doctors and patients, handling medical malpractice and liability cases, supporting disability determination and appeals procedures, and providing legal analysis of medical documentation.
Testing laboratory certification
Accreditation of a testing laboratory is the official confirmation of its technical competence and ability to carry out measurements or tests in accordance with established standards. For enterprises operating in manufacturing, medicine, food production, construction and other sectors, having an accredited laboratory is essential for ensuring trust in research results and compliance with legal requirements.
In this article, we will explain what accreditation is, which documents are required, what a laboratory accreditation certificate means, and why businesses should approach this process responsibly.
What is testing laboratory accreditation?
Accreditation is a procedure during which a competent authority checks:
- the laboratory’s technical capabilities;
- the qualifications of personnel;
- the compliance of equipment and measurement methods with standards;
- the quality management system;
- conditions ensuring accuracy and reliability of test results.
In Ukraine, laboratory accreditation is carried out according to standards including DSTU ISO/IEC 17025, which defines competence criteria for testing and calibration laboratories.
Laboratory Accreditation Certificate: a key document
The result of successful accreditation is a laboratory accreditation certificate. This official document:
- confirms the laboratory’s technical competence;
- defines the scope of activities and tests the laboratory is authorized to perform;
- contains information about the standards against which the laboratory was assessed;
- allows lawful use of test results for product conformity assessment, quality control, certification procedures and more.
The certificate has a validity period (usually 3–5 years), after which the laboratory must undergo reaccreditation. If technological processes change or equipment is updated, an unscheduled evaluation may be conducted.
Why businesses need an accredited laboratory
Reliability of results. The enterprise receives assurance that measurements are carried out using nationally and internationally recognized methods.
Access to international markets. An accreditation certificate simplifies mutual recognition of test results.
Legal protection. In case of disputes about product quality, protocols of an accredited laboratory have decisive weight.
Stages of laboratory accreditation
The procedure includes several key steps:
- Preparation of documents
The laboratory prepares:
- internal regulations;
- a list of equipment and its calibration/verification records;
- employee qualification documents;
- testing methods and protocols;
- internal standards, SOPs, and regulations;
- a quality management system.
- Submitting the application to the competent authority
The application includes the intended scope of accreditation, equipment characteristics, test methods and other relevant information.
- On-site competence assessment
Experts check:
- compliance of test methods;
- technical condition of equipment;
- documentation management;
- organization of workflows;
- compliance with ISO 17025 requirements.
- Decision and certificate issuance
If the laboratory meets all requirements, a laboratory accreditation certificate is issued with an indication of the scope of competence. 
Common reasons for accreditation refusal
- lack of calibrated equipment;
- insufficient personnel qualifications;
- outdated or non-validated methods;
- improper documentation management;
- partial non-compliance with ISO/IEC 17025 requirements;
- inadequate conditions for testing (temperature control, safety, cleanliness, etc.).
Accreditation of a testing laboratory is not a formality but a key element in ensuring quality, safety and reliability of measurements. A valid laboratory accreditation certificate opens significant opportunities for businesses — from participation in public procurement to entering international markets.
To avoid refusals and save time, companies should involve specialists who can:
- prepare the necessary documentation;
- conduct an internal audit according to ISO 17025;
- support the accreditation process until the certificate is obtained.
Do you still have questions about testing laboratory accreditation? Leave a request on the website — our lawyer will contact you!
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