The Management of Becerra Laboratory is always in compliance with all the normative requirements, and Quality Objectives, according to the Certification of ISO 9001: 2008. We follow the quality advice of ISO 15189, specific to clinical laboratory.
Our Quality Management System, collects all the requirements in Quality Manuals and Procedures, establishing a Quality Policy, with the purpose of guaranteeing the traceability and quality of the results obtained.
The Manuals of Procedures, explain in detail, all the processes that are performed in the Laboratory. We have described for each analytical technique we perform, a description of the whole process.
With our LAB SUITE 2000 software, Laboratory Management, any process performed is recorded, as well as the standardized daily work sheets that are archived. In the quality of the Clinical Analysis, to see the traceability, 3 phases are observed.
Pre-analytic
Phase
The patient requests an Analysis in the laboratory, is identified by the person who takes the samples, not only their personal data, but also their situation, pregnancy, medication, etc. There are certain factors that can vary some analytical determinations that we take into account to ensure the final quality of the Analysis, such as long physical exercise, prolonged fasting, diets, alcohol consumption, drugs, etc.
Once the sample is obtained we put bar codes on all tubes and containers. We pass your data to the computer.
We send the sample as soon as possible to the laboratory, taking into account the time elapsed and the temperature. There is a specific sample transport protocol.
There are sheets of records for any incident that may occur.
Analytical
Phase
It consists of carrying out the requested analysis. Previously the necessary controls and calibrations of the devices are made. The Internal Controls are registered for each parameter.
The steps of each Manual are followed, for the different parameters to be analyzed. We participate continuously in External Quality Control with AEFA / AEBM
Post-analytic
Phase
Samples are stored for a time in the freezer, for possible repetition, or by increasing the analytical request.
Once the results are obtained, they are validated by technical and specialist personnel, and then delivered to the patient.
The Laboratory Management ensures that all the people who influence the quality of the analyzes know the Policy and the Quality Objectives raised, since the Quality Manager, disseminates and controls the documents in all areas of the laboratory, and in the different Job positions.
