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 and ISO 13485:2016 standard.

This quality policy contributes to having systematized and optimized all the processes that are carried out for the scopes:

• Provision of quality control service of samples using electron microscopy (ISO 9001:2015)
• Metabolic analysis of biological samples by Nuclear Magnetic Resonance. (ISO 9001:2015)
• Design, development and manufacture of software to aid in the diagnosis of newborn congenital metabolic errors. (ISO 13485:2016)

It also implies the planning, organization and control of said processes, as well as the activities for their improvement; encourages the involvement of staff, the identification of risks and their reduction to achieve zero risk.

Located in the Science and Technology Park of Bizkaia (Derio, Bilbao), the activity of CIC bioGUNE includes generation of both fundamental and oriented knowledge (publications, patents, lectures in institutions and congresses), training of research talent, and collaboration-building with local, national and international institutions. The center always places their technical advances, infrastructure, and scientific personnel at the service of society, health and business networks, and the global scientific community.

CIC bioGUNE has modern scientific infrastructures, led by prestigious scientists, which allow it to compete with the main European research institutes. These include advanced equipment for nuclear magnetic resonance (NMR), electron microscopy and X-ray diffraction, as well as different core technology platforms where genomes, proteomes and metabolomes can be analyzed.

CIC bioGUNE's policy assumes the challenge of achieving the greatest satisfaction of the human team that makes up the organization, favoring a participatory environment among employees, integrating into the common objective and improving communications to facilitate teamwork, recognition individual and maintaining the commitment to continuous improvement making use of a correct management of resources. All this always focused on customer satisfaction and continuous improvement of processes.

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.

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ISO 9001 Electron Microscopy Certificate.

CIC bioGUNE aspires to establish itself as a national reference in the field of analyses that support medical professionals in the detection of congenital metabolic disorders during the earliest stages of life. This initiative aims to prevent unnecessary suffering for patients and reduce costs for both public and private healthcare systems. Furthermore, CIC bioGUNE is committed to advancing the detection of altered metabolites in biological samples through the application of Nuclear Magnetic Resonance (NMR) analysis. To achieve these objectives, the organization employs innovative technology that utilizes minimally or non-invasive human samples, enabling the evaluation of predispositions to various metabolism-related pathologies.

The policy of CIC bioGUNE, under the applicable framework of ISO 9001, is focused on the following strategic goals:

• Supporting the early detection of congenital metabolic disorders in neonates
• Advancing the early identification of contaminants in biological samples.
• Facilitating the early detection of altered metabolites in biological samples.
• Promoting the continuous and appropriate training of personnel, ensuring their awareness of and alignment with the objectives of the quality management system.
• Striving for excellence in sample analysis through the application of NMR technology.
• Ensuring effective and efficient management of resources.
• Maintaining and continuously improving the quality management system in an effective and efficient manner.

CIC bioGUNE’s policy embraces the responsibility of fostering the highest level of satisfaction among its team members. The organization is dedicated to cultivating a participatory and collaborative work environment, where employees are integrated into a shared objective. Enhanced communication is prioritized to facilitate teamwork, recognize individual contributions, and reinforce commitment to continuous improvement through the management of resources responsible.

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ISO 9001 NMR EN - ES

At CIC bioGUNE, we are dedicated to providing solutions through high-quality software that contribute to the early and accurate detection of congenital metabolic errors, thereby improving healthcare and the quality of life for patients. We commit to complying with all applicable regulatory and normative requirements, including ISO 13485, and to continuously improving our Quality Management System (QMS).

Our Fundamental Principles:

1. Quality and Safety: We strive to develop and maintain software that meets the highest standards of quality and safety, ensuring accuracy in assisting with the detection of congenital metabolic errors while minimizing any risks to patients and healthcare professionals.
2. Regulatory Compliance: We allocate our resources to comply with all applicable legal and regulatory requirements, including ISO 13485, and to stay informed of any changes in these requirements.
3. Continuous Improvement: We seek continuous improvement in all aspects of our QMS and software development processes by identifying improvement opportunities and implementing corrective and preventive actions.
4. Training and Development: We provide our personnel with the necessary training and development to ensure they are competent and committed to the quality and safety of our software.
5. Communication and Transparency: We foster effective communication both internally and externally, promoting transparency in all our operations and pledging to act with ethics and responsibility in all our interactions.

Quality Objectives:
Our commitment to quality is reflected in the following key objectives:

• Ensure that our software complies with the precision and safety standards established for assisting in the early detection of congenital metabolic errors following the guidelines of Regulation (EU) 2017/746.
• Maintain an effective quality management system that complies with the requirements of ISO 13485 and applicable regulatory requirements.
• Ensure customer and patient satisfaction through continuous care and high-quality support.
• Promote a culture of continuous improvement and responsibility throughout the organization.
• Adapt quickly to changes in technology and regulations to keep our software up to date and in compliance with the latest standards.

This quality policy guides our operations and decisions, and every member of our team is responsible for upholding it. Through our commitment to these principles and objectives, CIC bioGUNE aims to be a leader in delivering reliable and secure software solutions for assisting in the early detection of congenital metabolic errors.

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ISO 13485 Software e-COMETA.