Quality policy
Quality Policy
The senior management of CIC bioGUNE defines the quality policy as a fundamental and indispensable pillar for the correct implementation of a quality management system according to the ISO 9001:2015 standard. This quality policy contributes to having systematized and optimized all the processes that are carried out for the scopes:
- Newborns urine sample screenning for the detection of inborn errors of metabolism.
- Provision of quality control service of samples using electron microscopy
Scope: Provision of quality control service of samples using electron microscopy
CIC bioGUNE seeks to be a national benchmark in the provision of quality control service for our client's samples. To achieve this, there is a laboratory equipped with two transmission electron microscopes whose high-level technology allows us to obtain a 3D representation (3D map) of the biological object with sub-nm size resolution from 2D analysis of the samples.
Senior management has established the CIC bioGUNE policy in the area that applies to us (ISO 9001:2015) and its purpose is:
- Provide quality control service for samples from external companies and position themselves as leaders in this field.
- Promote continuous and appropriate training of staff and their awareness of the objectives of the quality management system.
- Excellence in the analysis of the quality of the samples by means of Electron Microscopy.
- Effective resource management.
- Effectively and efficiently maintain the quality management system and that it complies with the requirements of the ISO 9001:2015 standard.
- Make sure that the processes generate the desired outputs.
- That the responsibilities and authorities for the roles are defined, communicated and understood for each of the positions within the quality management system.
- Information to senior management on the performance of the Quality Management System, as well as opportunities for improvement.
- The assurance of the integrity of the system before any planning and implementation of changes in the system.
- That the customer approach is known throughout the organization. Know the needs of the client to achieve customer satisfaction with the service provided.
- Knowledge of the risks that may affect the system and the establishment of actions to minimize or eliminate them without generating additional risks.
- Comply with applicable regulatory requirements.
Coming soon.
Scope: Newborns urine sample screenning for the detection of inborn errors of metabolism
CIC bioGUNE seeks to be a national benchmark in carrying out analyzes that help medical specialists in the detection of inborn metabolic errors in the initial stages of life, thus avoiding unnecessary suffering for patients and saving costs for both public and public health as private. To achieve this, innovative technology is available that uses easily obtained human samples (urine) and that allows the tendency to suffer from these pathologies to be evaluated. CIC bioGUNE's policy in the area that applies to us (ISO 9001:2015), aims to:
- Help for early detection of congenital metabolic errors in newborns.
- Promote continuous and appropriate training of staff and their awareness of the objectives of the quality management system.
- Excellence in sample analysis using NMR.
- Effective resource management.
- Effectively and efficiently maintain the quality management system.
- Make sure that the processes generate the desired outputs.
- That the responsibilities and authorities for the roles are defined, communicated and understood for each of the positions within the quality management system.
- Information to senior management on the performance of the Quality Management System, as well as opportunities for improvement.
- The assurance of the integrity of the system before any planning and implementation of changes in the system.
- That the customer approach is known throughout the organization. Know the needs of the client to achieve customer satisfaction with the service provided.
- Knowledge of the risks that may affect the system and the implement of actions to minimize or eliminate them without generating additional risks.
- Comply with applicable regulatory requirements.