Quality in BioXcellerator is a priority that ranges from the technical processes to the general processes that are related to the comprehensive care of the patient. We have a Quality Management System, based and structured compliance with national and international cross-cutting standards, defined in the following regulations, which allows us to ensure processes in all its phases:
We are certified by the Secretary of Health of Antioquia under the National Enabling Regulation (Resolution 2003 of 2014).
Standards for Good Practices for Tissue Bank, INVIMA.
CAT Standards (Foundation for Quality in Blood Transfusion, Spain)
ISO 9001: 2015 Regulation
ISO 14644, Air quality in controlled systems
ISO 13022: 2017 Products containing viable human cells. Application of Risk Management and Requirements for processing practices
Our physical facilities are designed under risk management models, fluid flow processes, easy for the user and companions and differentiated and pleasant spaces, comfortable and safe to make them feel at home.
Our scientific technical staff are highly credentialed and recognized with appropriate levels of certified experience that ensures the safety of our processes.
The available equipment in our laboratory and affiliate laboratories is of the highest technology that gives security to each and every one of the procedures that are executed. We have strict quality controls in the different processing phases, to guarantee not only the sterility of the processes, but also the environments in which the products are made.
We have standardized processes that are put to the test through periodic audits and measurement of adherence to previously standardized protocols and methods.
Our protocols have systems of validation of previous methods before their application, with the aim of ensuring the quality and traceability of the results.
Our key to success has been the correct selection of standards to be implemented independently of our national evaluation model.
