Laboratorio Aragó S.L. is committed to designing, developing and producing suture materials and staples and other dressing materials, importing sterile and non-sterile gloves, groupings of systems and kits for procedures and distributing them under the highest quality standards to meet our customers’ requirements, as well as all legal and regulatory requirements, by maintaining the effectiveness of our implemented Integrated Management System.

Top Management are responsible for achieving this goal, which is also made possible by the commitment and participation the organisation’s staff at all levels.

Laboratorio Aragó S.L. is certified under the requirements of globally recognised International Standards:

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

• ISO 9001:2015 Quality management systems

• ISO 14001:2015 Environmental management systems

Additionally, all products comply with Directive 93/42/EEC, which ensures the System for Design, Manufacture and Marketing of Products, and the company is making the transition to Regulation (EU) 2017/745 of the European Parliament and of the Council, of 5 April 2017, on medical devices. The surgical sutures manufactured and/or grouped by Laboratorio Aragó S.L. comply with European and American Pharmacopoeia standards.

Laboratorio Aragó S.L.’s dedication goes beyond adhering to internationally recognised standards and extends to the attitude throughout the company, as relies on highly trained staff who are always aware that the products manufactured are used to cure people, both in Spain and internationally. In this, Laboratorio Aragó commits to:

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

• protect the environment by establishing the actions necessary to prevent pollution that could arise from its business, as well as by making responsible use of natural resources.

• facilitate and support everyone’s application and awareness of the Integrated Management System by means of appropriate communication and training, to ensure that this policy is understood, implemented and maintained.

The company’s Top Management also sets measurable quality and environmental targets that are consistent with the Quality and Environmental Policy, including those necessary to comply with product requirements and those needed to improve environmental performance. These are reviewed and analysed periodically, together with the policy, in the Integrated Management System Review.

Barcelona, 3 December 2019

Xavier Aragó Fonts

General Manager, Laboratorio Aragó S.L.