PRIM is a company that produces orthoses, orthopaedic products, and also offers distribution and technical services for medical devices, in addition to manufacturing. marketing and after-sales services for physiotherapy and rehabilitation products. They state that while carrying out their activities they prioritise quality and the environment in order to satisfy the needs of their customers at all times, providing a competitive product, with the participation of everyone and respectful of the environment.

The PRIM S.A. quality and environmental system includes all the applicable requirements included in the UNE-EN ISO 13485:2016, UNE-EN ISO 14001:2015 and UNE-EN ISO 14064-1:2019 Standards.
The scope of PRIM’s quality and environmental system applies to:

• The design, manufacture and distribution of orthoses, orthopaedic products and rehabilitation and physiotherapy products.
• The distribution and technical service of medical and non-medical devices.
• The grouping of medical devices with CE Marking.

The general Quality and Environmental guidelines and objectives that guide PRIM are listed and embodied in its Quality and Environmental Policy which, as defined by the Board of Directors, is part of the company’s general policy and is consistent thereto.

The Quality and Environmental Guidelines are:

• Commitment to meet the requirements and maintain the effectiveness of the Quality and Environmental System.
• Ensure that the products and services provided to our Customers are safe, dependable, and comply with applicable specifications, standards, and codes.
• Maintain constant contact with Clients, collaborating together to improve our products and services.
• Establish actions and programmes aimed at prevention, and not only at detection and correction.
• Measure and analyse all data related to Quality and the Environment in order to ensure the continuous improvement of the organisation.
• Commitment to prevent contamination at all phases of the product development and distribution process.
• Organisation-wide commitment to prevent contamination and to protect the environment.
• Application of all applicable legal requirements to the rendering of services and distribution of products, as well as those specific to the context of the organisation and stakeholders.
• Develop programmes for the improvement of those products and services provided in regard to technological, environmental and quality factors.
• Instruct, motivate and involve all staff in the management and development of the implemented Quality and Environmental System.

In order to implement this Quality and Environmental Policy, PRIM will carry it out in accordance with the following directives and standards:

• Regulation (EU) 2017/245 regulating medical devices and 746/2017 in vitro diagnostic medical devices.
• UNE-EN-ISO 13485:2016. Medical devices. Quality management systems. Requirements for Regulatory Purposes.
• UNE-EN ISO 14001:2015. Environmental Management System.
• UNE-EN ISO 14064-1:2019 Specification with organisational guidance on the quantification and reporting of the emission and scrapping of greenhouse gases.

This Policy is reviewed at least once a year and updated when it is deemed that certain changes have arisen that warrant said updates.

This Policy therefore provides the framework for establishing and reviewing the environmental objectives and goals of the management system and is aligned to the overall purpose and context of the organisation.

This Policy will be available to stakeholders, with the communication channels also defined.

The PRIM Board of Directors demonstrates its commitment through this statement and is responsible for ensuring that the system is understood, applied and kept up to date at all levels of the organisation.

(*) Document taken from the PRIM Quality and Environmental Manual, review 21st May 2023, section 5.3.