MaTestLab > ISO Standards > ISO 15189 Medical Laboratories- Requirements for Quality and Competence
Last updated 9th June 2025
ISO 15189 Medical Laboratories- Requirements for Quality and Competence
ISO 15189 is a standard for medical laboratories that focuses on quality and competence requirements. It provides guidelines for the establishment and management of a quality management system in medical laboratories that meets the needs of patients, regulatory bodies, and other stakeholders.
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Introduction to ISO 15189
ISO 15189 is a specific standard for medical laboratories, as opposed to ISO 9001, which is a more general quality management standard. The standard was developed by the International Organization for Standardization (ISO) in collaboration with the International Laboratory Accreditation Cooperation (ILAC) and the International Electrochemical Commission (IEC). ISO 15189 is intended to be used by medical laboratories of all sizes and types, including those in hospitals, clinics, research facilities, and independent laboratories.
The standard specifies the competence and quality requirements that medical laboratories should meet to ensure the accuracy and reliability of their results. MaTestLab is one of the leading testing service providers in the USA and Canada. We have a large network of testing laboratories in the USA.
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ISO 15189 Test Method
ISO 15189 specifies a number of requirements for medical laboratories to meet in order to demonstrate their competence and quality. These requirements are organized into five main areas:
Management requirements
This section covers the laboratory’s management structure, documentation, and responsibilities, including the need for a quality manual and a quality management representative.
Resource requirements
This section covers the laboratory’s physical resources, such as equipment, facilities, and human resources. It also includes requirements for ensuring the competency of staff and ongoing training and development.
Process requirements
This section covers the laboratory’s testing processes, including the selection and validation of methods, quality control, and proficiency testing.
Measurement requirements
This section covers the laboratory’s calibration and verification procedures, including the use of reference materials and equipment.
Results reporting and interpretation
This section covers the laboratory’s procedures for reporting test results, including the format, content, and timeliness of reports. It also includes requirements for record keeping and data management.
ISO 15189 Specimens
The specimen for ISO 15189 is not applicable since this is a standard for laboratory management and does not involve any specific laboratory tests. However, the standard does require laboratories to have procedures in place for the selection and validation of testing methods, including the selection of appropriate specimens.
ISO 15189 Results
The results of implementing ISO 15189 include the establishment of a quality management system in medical laboratories that meets internationally recognized standards for competence and quality. This can lead to increased confidence in laboratory results and improved patient outcomes. The following outcomes can be achieved as a result:
Improved accuracy and reliability of test results
Increased patient safety and satisfaction
Increased confidence in laboratory results
Improved laboratory efficiency and effectiveness
Improved communication and collaboration with healthcare providers
Tests related to ISO 15189
Related methods to ISO 15189 include ISO 17025, which is a standard for testing and calibration laboratories that shares many of the same requirements for competence and quality management. ISO 15189 focuses specifically on medical laboratories and includes additional requirements specific to the medical field.
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FAQ's
Where can I get the iso 15189 tested?
You can share your iso 15189 testing requirements with MaTestLab. MaTestLab has a vast network of material testing laboratories, spread across the USA and Canada. We support your all material testing needs ranging from specific iso 15189 test to various testing techniques.
How much do I need to pay for the iso 15189 test?
Please contact us for a detailed quote for your iso 15189 testing needs. Cost incurred to carry out different iso 15189 testing methodology depends on the type of raw material; number of samples, coupons, or specimens; test conditions, turn around time etc. Costs of some ASTM testing methods start from $100 and the final value depends upon the factors listed above. Please contact us for the best and latest prices.
How many samples are required for iso 15189?
The required number of samples or specimens should comply with the procedure given in the iso 15189 standard. However, the MaTestLab operations team can assist you for your special requirements once you share your testing details with us.
How much discount can I get on the iso 15189 test?
MaTestLab has a vast testing laboratory network, hence we bring you the best testing facilities in a cost-effective way. We offer considerable discounts (15-20%) to our returning customers based on test volume and frequency.
How many days will it take to complete the iso 15189 test?
The turnaround time for iso 15189 test methodology depends upon the test procedure mentioned in the standard test document. However, we at MaTestLab understand your research requirements and hence try to get your test completed within the least possible time.
Where can I get the iso 15189 tested?
You can share your iso 15189 testing requirements with MaTestLab. MaTestLab has a vast network of material testing laboratories, spread across the USA and Canada. We support your all material testing needs ranging from specific iso 15189 test to various testing techniques.
MaTestLab Inc. offers accessible, quick, and affordable material testing, product testing, and failure analysis services. We support your on-demand testing and expert consultation needs with the help of our extensive network of material testing laboratories situated in the US and other parts of the world.
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