53Biologics considers that quality is an essential factor for the success of the organisation and therefore the quality and environmental policy is based on a firm commitment to customers to fully satisfy their requirements and expectations. To this end, we guarantee to promote a culture of Quality and Environment by adopting the most demanding international standards, namely:

ISO 9001:2015 Quality Management Systems and ISO 14001:2015 Environmental Management Systems for cell line construction services, cell bank construction and characterisation services, analytical services, process design and optimisation services and contract production services.

The company establishes this quality policy, the objectives and the means to achieve it. The Company is also responsible for the communication and transmission at all levels of the organisation of the Quality and Environment objectives, for which training, and its appropriate planning, is a key element.

This Policy is put into practice by setting the following objectives:

  1. Commitment to meet the explicit and implicit requirements and expectations of customers, legal and regulatory, and the application of quality criteria required for the defined scope.
  2.  Disseminate quality objectives and criteria at all levels.
  3.  Implement the objectives and quality indicators, as well as monitor the level of progress of these, so as to allow monitoring of the effectiveness of manufacturing processes and the quality of products.
  4.  Ensure that the working conditions are optimal by assessing the risks that may arise in the processes, and eliminating as many of them as possible and reducing those evaluated.
  5. Develop continuous training programs aimed at the best qualification of workers, thus involving all staff in achieving all the objectives set forth in this document.
  6. Consolidate the process of continuous improvement in the performance of all activities carried out in the company. To this end, both the Management and all those responsible for it depend on the periodical reviewing of the effectiveness of the Quality System. This is to ensure that appropriate measures are taken so that contiguous improvement becomes effective.
  7. Promote and implement a motivating environment for all members of the company.
  8. The protection of the environment, including the prevention of pollution, within the context of our organization.

Management makes this policy accessible and available to its customers, all employees, suppliers and the general public. The Integrated System is also kept up to date through regular reviews, which include a management review to take into account changes in environmental conditions, objective data on its application and feedback.