Quality and Environmental Policy

 

Laboratorio Aragó S.L. is committed to the design, development, and production of suture materials, staples, and other wound care products, the importation of sterile and non-sterile gloves, and the assembly and distribution of systems and kits for surgical procedures, under the highest quality standards that meet our customers' requirements as well as legal and regulatory requirements, through the ongoing effectiveness of our Integrated Management System.

It is the responsibility of Senior Management to achieve this objective, which is also made possible through the commitment and involvement of staff at all levels of the organization.

Laboratorio Aragó S.L. is certified under the requirements of internationally recognized standards:

  • UNE-EN ISO 13485:2018 Medical Devices. Quality management systems.

  • ISO 9001:2015 Quality management systems

  • ISO 14001:2015 Environmental management systems

The company offers products certified under Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017, as well as products certified under Directive 93/42/EEC, meeting the conditions for the legal extension of validity required under Article 120.2 of the MDR and Regulation (EU) 2023/607. These certifications ensure the integrity of the Design, Manufacturing, and Marketing System of the products. All surgical sutures manufactured and/or assembled by Laboratorio Aragó S.L. comply with European and U.S. Pharmacopoeia standards.

Laboratorio Aragó S.L.'s commitment goes beyond adherence to internationally recognized standards and extends to the attitude of the entire company, as it has highly trained staff who are always aware that the products manufactured are used to heal people, both nationally and internationally. For this reason, Laboratorio Aragó is committed to:

  • continuously improving the Integrated Management System to enhance quality and environmental performance.

  • protecting the environment by establishing the necessary actions to prevent pollution that may arise from its activities, as well as to make responsible use of natural resources.

  • facilitating and supporting, through appropriate communication and training, the application and understanding of the Integrated Management System among all members of the organization, to ensure that this policy is understood, implemented, and maintained.

All personnel of the organization maintain respectful conduct with regard to both the rules and the ethical values defined in the Criminal Compliance Policy.

Likewise, the company's Senior Management establishes measurable quality and environmental objectives that are consistent with the quality and environmental policy, including those necessary to meet product requirements and those necessary to improve environmental performance, which, together with this policy, are periodically reviewed and analyzed during the Integrated Management System Review.

Barcelona, October 10, 2025

Xavier Aragó Fonts

General Manager, Laboratorio Aragó S.L.