Clinical laboratories are distinguished from other testing laboratories by their handling of human samples and sampling in humans. The requirements for sampling, sample handling, analysis and performance of the results to the interested party are described in ISO 15189: 2012.
The clinical laboratories with the accreditation according to ISO 15189: 2012 document the technical adequacy of the staff and the suitability of the laboratory in carrying out laboratory tests. It is indeed "vital" that the results are correct and with a certain measurement uncertainty, so that there is proper evaluation and further use by medical staff.
Organizations seeking ISO 15189 accreditation:
- Clinical laboratories handling human samples
HELLASCHEM ensures the provision of the highest quality consulting work for the preparation, implementation and accreditation according to ISO 15189, thanks to:
- To its well-trained staff
- In the constant pursuit of quality in the field of analysis
HELLASCHEM provides:
- Consulting service for the development, implementation and accreditation of an organization according to ISO 15189: 2012
- Internal inspections to check the correct application of ISO 15189: 2012
- Training of staff in matters of accreditation, such as determination of measurement uncertainty, quality control charts, etc.
- Maintenance and extension of an existing ISO 15189: 2012 system
- Laboratory analyzes for the control of air, facilities and waste
- Combined application of ISO 17025 with other standards such as ISO 9001, ISO 14001, ISO 45001