Quality Management Systems Certificate ISO 9001:2015

The ISO 9001 standard for quality management systems provides the infrastructure, procedures, processes and resources necessary to help organizations control and improve their performance, and to drive them towards efficiency and product excellence. ISO 9001 is the model to which hundreds of thousands of organizations around the world refer their quality management systems.

REGNER^® is certified according to the UNE-EN ISO 9001 standard. This certification confirms that the company has implemented a Quality Management System according to this standard with the capacity to consistently provide products and services that meet customer requirements and applicable regulations.

Certificate of quality management systems for medical devices ISO 13485:2016

ISO 13485 for medical devices is an internationally recognized quality management system for manufacturers of medical equipment and related services.

REGNER^®, manufacturer of solutions for the medical equipment sector, is certified according to UNE-EN ISO 13485. This certification confirms that the procedures and practices carried out in the area of quality management of components and electromechanical assemblies for medical equipment adequately meet the requirements of this standard, and that they are conveniently implemented.

The main goal of the standard is to establish a set of harmonized regulatory requirements for quality management systems within the medical device sector. The ISO 13485 standard is a worldwide benchmark for good practice in medical equipment quality management systems.

Certificate of environmental management systems ISO 14001:2015

ISO 14001 establishes the guidelines that an organization must follow to establish an effective environmental management system, indicating to employees, customers, and suppliers that its environmental impact is being measured and improved.

In accordance with its commitment to the environment and sustainability, REGNER^® has implemented an environmental management system in accordance with the UNE-EN ISO 14001 standard. This certificate attests that REGNER^® applies the latest and most demanding environmental management criteria, beyond current legislation.