The management of LABORATORIOS KLEIN COSMÉTICA, S.L.U. establishes this Quality Policy as an expression of its commitment to the contract manufacturing of medical devices and to the maintenance of a Quality Management System in accordance with Standard UNE-EN ISO 13485:2016/A11:2021 and with the applicable legal and regulatory requirements, in particular Regulation (EU) 2017/745 and the applicable national legislation.

The objective of this system is to ensure that the products and services supplied comply with the specifications agreed with clients, the applicable legal and regulatory requirements, the established quality agreements and the internal requirements defined by the organisation.

As a third-party manufacturer of Medical devices, the organization carries out its activities in accordance with the regulatory responsibilities contractually assigned to it, collaborating with legal manufacturers to ensure that the products manufactured comply with the approved specifications, the established quality agreements and all applicable legal and regulatory requirements. The organization identifies and maintains documented the regulatory roles and responsibilities applicable to each project, without assuming undefined or undocumented functions.

Management considers that the trust of our customers can only be achieved through planned, documented, controlled and traceable processes, carried out by competent personnel and aimed at ensuring the conformity of the products and the effectiveness of the Quality Management System.

To achieve this purpose, Management declares the following principles and commitments:

• Commitment to comply with the legal, regulatory, normative and contractual requirements and the quality agreements applicable to each project.
• Manufacture the products in accordance with the previously approved specifications, manufacturing methods, controls and instructions, ensuring the integrity of the documentation, traceability and the reliability of the records.
• Evaluate the risks associated with the processes that are the responsibility of the organization and implement the necessary measures to preserve product conformity, process continuity and the effectiveness of the Quality Management System, applying a risk-based approach in accordance with the principles of ISO 14971 where applicable.
• Maintain transparent, effective and documented communication with customers, especially in relation to changes, deviations, incidents, nonconformities and any situation that may affect the product or compliance with the established agreements.
• Have competent, trained personnel who are aware of the impact of their activities on quality, product safety and regulatory compliance.
• Ensure that the facilities, equipment, infrastructure, environmental conditions and suppliers are suitable for the activities performed and remain under control throughout the entire manufacturing cycle.
• Maintain and improve the effectiveness of the Quality Management System through the monitoring of measurable quality objectives, data analysis, management of incidents, internal audits, Management Review and implementation of improvement actions where necessary.
• Provide the human, technical and economic resources necessary to ensure the maintenance of the Quality Management System and compliance with this policy.

This Quality Policy provides the framework for establishing and reviewing measurable quality objectives, consistent with product requirements, applicable regulatory requirements, customer requirements and the effectiveness of the system.

This policy shall be communicated and explained to personnel to ensure its understanding and application. Likewise, it shall be available to customers, suppliers, competent authorities, certification bodies and other relevant interested parties, where appropriate.

Management shall periodically review this Quality Policy to ensure that it continues to be appropriate to the scope of third-party manufacturing activities, the applicable requirements and the purpose of the organization.