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.
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.
