QUALITY
Internal Quality Certificates
Quality in our activity sector means Responsibility: Vircell fulfills it from the very beginning of the production process, as it is one of the main pillars on which our business idea is based. At present, the quality of our products is guaranteed by the fulfillment of an exhaustive quality management system, based on a modern and global regulation: ISO 9001. All activities of R&D, Production, Sales and After-sales are audited and certified according to this directive. However and undoubtedly, our biggest satisfaction is the confidence that laboratories from any part in the world put in us every day.
Since 2022, in vitro diagnostic reagents must incorporate the CE marking by complying with REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 5, 2017 on medical devices for in vitro diagnostics. Vircell works continuously to comply with this regulation. In 2023, Vircell was granted the ISO 13485 certification by the notified body TÜV SÜD, which certifies our quality assurance system.
Moreover, the company is implementing a global adaptation system to GMP regulation, necessary to obtain the FDA approval.
Certificates
Corporate policy
We are aware that to continuously improve both our system and the products manufactured and services rendered, we must consider patient safety, the expectations of our customers and their needs as well as legal and regulatory requirements, being our main commitments:
- Comply with the requirements of the UNE-EN ISO 13485:2016/A11:2021, UNE-EN-ISO 9001:2015, and UNE- EN- ISO 14001:2015, IVDR, MDSAP-CMDR and MDSAP-FDA.
- Identify and provide necessary resources to implement and maintain the Quality and Environment Management System, rationally using all resources.
- Routing our Quality Management System and Environmental Management System to guarantee patient safety, to meet the legal and regulatory requirements of the different Regulatory Authorities that form part of our context, to meet the needs and expectations of our Customers and to prevent and reduce the Environmental Impacts generated by the activity of the organization, as the central task of our environmental policy.
- Improving the quality of life of patients through innovation.
- To consider patient care and safety as the heart of what we do.
- Strive to achieve the highest quality standards in our products to ensure that our customers can rely on accurate information for the best patient care.
- Protect the environment including the prevention of pollution and the sustainable use of resources.
- Identify and assess risks, determine necessary improvement actions in processes and evaluate the effectiveness of these to mitigate those risks.
- Establish annual strategic objectives of the organization and goals that are measurable and consistent with the policy of the organization.
- To orientate the company's management towards the reduction, elimination and prevention of management deficiencies and, most importantly, towards continuous improvement of the system that meets legal and regulatory requirements, as well as customer requirements and patient safety as effectively as possible.
- Record, assess and regularly monitor the environmental effects of our processes.
- Promote awareness of all staff and partner companies, so that this quality and environmental policy is understood and accepted.
In the organization we believe that environmental protection is not only legal issue, but is a social obligation for the entire company that develops and progresses together and parallel to the community to which it belongs. This requires the commitment and participation of all staff of the organization, based on knowledge of this policy and the proper implementation of the Manual Integrated Management, General Procedures and all documentation is part of the Integrated Management System.
The objectives include a commitment to compliance with applicable laws and regulations by evaluating their interactions with the environment and the application of best available technologies economically viable.
The management is committed and requests the commitment of all employees of the company, to the extent they are concerned to develop, refine and implement quality criteria and environmental respect defined in the documents of the Integrated Management System and compliance of targets set for the corresponding periods.
The management,
Environmental policy
Vircell, S.L., in its vocation and commitment to the Environment, annually performs an Environmental Performance evaluation and, through this evaluation, measures are established, some of which become environmental objectives.
This report aims to announce the activities that have been carried out, the results of the environmental objectives proposed for that year and identify possible areas for improvement for the future.
Next, the points that we will discuss during this report:
- Review of compliance with environmental legislation
- Environmental objectives. Year 2024
- Environmental aspects
- Internal training
- Planning and response to environmental emergencies
- Final comment
Review of compliance with environmental legislation
At least twice a year, a review of the fulfillment of legal requirements regarding the environment is performed. This process serves to check that the previously identified requirements continue to be met and that the new legislation enacted in this matter is taken into account.
Environmental objectives. Year 2024
The environmental objective defined for 2024 relative to the reduction of water consumption (m ³) per thousand kits by 1% has not been achieved.
Consumption has not increased in. However, when referring to the number of kits manufactured, this target has also been affected by the substantial drop in the number of kits manufactured.
Environmental aspects
An identification and evaluation of environmental aspects is carried out.
This identification of aspects has been reviewed on April 11th, 2025 and the evaluation of its impacts has been recalculated, obtaining as a result that most aspects, except 3, are not significant, due mainly to the control of the same.
The aspect that has been significant is the following:
- Obsolete IT equipment (computers, printers, etc.) (200135).
- Diesel consumption.
- Consumption of sodium hypochlorite.
The environmental aspects that stand out for having experienced an improvement over the previous year:
- Obsolete fluorescent and ultraviolet tubes (200121).
- Absorbents, filters and contaminated rags (150202).
Internal training
All personnel newly incorporated to Vircell, S.L. receives specific training related to the environment. The courses are the following:
- Environmental management
On the other hand, specific personnel are trained with particular courses for theTransfer of hazardous waste and for General guidelines for waste disposal.
Planning and response to environmental emergencies
Annually, and in order to validate the planning and response to environmental emergencies and to ensure their adequate knowledge by the personnel, a practical simulation is carried out so that the staff knows first-hand how to act in case of environmental emergencies.
Final comment
As explained in this report, the main environmental processes that affect our activities are being effectively applied and controlled.
And for the record and for the appropriate purposes the environmental performance is publicly communicated through the company's website.
