Medical laboratory SMTS
A medical laboratory provides reliable results for the diagnosis, prevention and treatment of disease. Accreditation to ISO 15189 ensures quality, competence and patient safety throughout the entire examination process, guaranteeing reliable, traceable findings.
A medical laboratory is a specialised healthcare facility that examines human, patient-related samples to provide reliable information for the diagnosis, monitoring, prevention and treatment of disease. The international standard ISO 15189 sets out requirements for quality, competence and safety, placing patient welfare and the satisfaction of laboratory users at its centre.
The activities of a medical laboratory cover all steps in the examination process: from the examination request, patient preparation and identification, and sample collection and transport, through to analysis, evaluation and release of findings. This also includes point-of-care testing (POCT), the reporting of critical results and professional advice to laboratory users.
Accreditation confirms that the medical laboratory has qualified staff, appropriate premises and equipment, and validated examination procedures, with quality assurance measures that ensure results are reliable and traceable, so that medical decisions can be made on a sound basis.
Accredited medical laboratories provide a reliable foundation for correct treatment decisions, making a significant contribution to patient welfare.
General documents for medical laboratories
Directories for medical laboratories
Transitional regulations
Chemistry
Changes to the accreditation of medical laboratories (SMTS)
Accreditation of medical laboratories is now only carried out in accordance with the ISO 15189 standard
With EA Resolution 2022 (52) of November 23, 2022, all medical laboratories must be accredited to ISO 15189 in future.
The transition period for medical laboratories accredited under ISO/IEC 17025:2017 (Swiss Testing Service STS) to switch to the new standard ISO 15189:2022 (Swiss Medical Testing Service SMTS) is set at five years from the date of publication of the above-mentioned resolution. Consequently, the last day of validity of the current ISO/IEC 17025:2017 standard for the accreditation of medical laboratories is November 23, 2027.
The only exceptions:
Where national regulations require a medical laboratory to be accredited in accordance with the international standard ISO/IEC 17025, this is accepted by the EA, the European umbrella organisation for national accreditation bodies. Furthermore, the ISO 15189:2022 standard cannot be applied to activities that are not directly patient-related. In such cases, the ISO/IEC 17025 standard remains the basis for accreditation.
Based on the above-mentioned resolutions of the EA General Assembly, the SAS specifies below the details for the transition of the accreditation of medical laboratories, which were previously accredited according to the standard ISO/IEC 17025:2017, to the standard ISO 15189:2022.
Index
Key areas of application for this accreditation
Medicine and Health
The medicine and health sector safeguards the quality of life of humans and animals.
Contact
Swiss Accreditation Service SAS
Holzikofenweg 36
CH - 3003 Bern