ISO 15189 – Medical laboratories – Requirements for quality and competence
Scope of the Standard: ISO 15189 specifies requirements for quality and competence in medical laboratories.
Recipients of our consulting services: medical laboratories willing to get accredited according to this Standard; these generally belong to private or public structures operating through laboratory diagnostics, such as: cytology, haematology, cellular and molecular biology, microbiology, immunology, bacteriological, serological, clinical chemistry, etc.
We are firmly convinced that the only international standard to be used by medical laboratories to develop their Quality Management System as well as assess and confirm their competence is ISO 15189.
In order for medical laboratories to grant the quality of the results of the analyses carried out, the following aspects need to be considered:
- Calibration carried out in a traceable way
- Knowledge of the uncertainty associated with the results
- Check and identification of any eventual disruptors
- Suitable environmental conditions
- Scheduled quality assurance
Not only are technicians responsible for the results of medical analyses, but also the equipment, methods and environmental conditions: all of them equally contribute to a correct testing session.
The management and implementation of the processes requested by ISO 15189 can prove to be a very long and complex pathway: our team of professionals can guide and support medical laboratories during the whole Accreditation process.
Some of our services (non-exhaustive list):
- Initial meeting with the customer: analysis of the existing operating processes
- Definition of the best path to take, defined in accordance with the customer’s needs and expectations, type of analysis carried out, etc., in order to adapt the existing Management System to the requirements of this Standard
- Training of the personnel involved in the various processes (analytical and/or not), support during the uncertainty reduction process and continuous improvement, also by means of the auxiliary Standard ISO 22367 – Medical laboratories – Application of risk management to medical laboratories
- Support during the control phase
- Planning of the periodic monitoring audit
Some of the advantages deriving from the implementation of a Quality Management System compliant to ISO 15189:
- The implementation of the aforementioned Mangement System will be a clear evidence of compliance with the applicable requirements, and a guarantee of quality services in the relevant medical field
- The opportunity to distinguish themselves from non-accredited laboratories
- The chance to participate to tenders exclusively intended for ISO 15189 accredited laboratories
- The ability and competence to monitor and control every aspect of the analytical process in a scientific way, from instruments calibration to analytical methods, the identification of any possible perturbants, the analytical process itself and data release, whose quality will be assured
- A laboratory accredited in accordance with ISO 15189 will be more recognizable at national/international level, and its business processes will be stronger and more successful
- Greater level of participation and commitment of the staff involved and trust from service users
