Quality

Innovation and quality is our company philosophy. Highly professional teams ensure continually the development and launching of new products and constant improvement in product quality and efficiency, as well as especially designed products to meet the requirements of specific customers / markets.

Our products, considered as medical devices, are manufactured according to the CEE Medical Device Directive 93/42/EEC and its update Directive 2007/47/EC.

Our operations and procedures are developed according to the requirements of ISO 13485:2016 standards.

QUALITY AND ENVIRONMENTAL POLICY 

PRIM manufactures orthotics and orthopaedic products, and distributes and provides technical services for medical devices, manufactures, markets and provides after-sales service for physiotherapy and rehabilitation products. It declares that Quality and respect for the environment is a priority in the performance of its activities in order to satisfy the needs of its clients at any time, with a competitive product, with the participation of all those involved and respect for the environment.

1. a) The PRIM S.A. quality and environmental system includes all applicable requirements contained in the UNE-EN ISO 13485: 2016 and UNE-EN ISO 14001: 2015 Standard.

The scope of PRIM’s quality and environmental system applies to:

• Design, manufacture and distribution of orthotics and orthopaedic products.
• Manufacture of products for rehabilitation and physiotherapy.
• Distribution and technical service for medial and non-medical devices.
• Grouping together of medical devices with CE marking.

PRIM’s Quality and Environmental guidelines and general objectives are combined and reflected in its Quality and Environmental Policy, which is defined by Management and is part of the company’s general policy and consistent with it.

The Quality and Environmental guidelines are:

• Commitment to comply with the requirements and maintain the efficiency of the Quality and Environmental System.
• Ensure that the products and services supplied to our Clients are safe and reliable and comply with the applicable specifications, standards and codes.
• Maintain permanent contact with Clients, collaborating together in the improvement of our products and services.
• Establish actions and programmes aimed at prevention, not just detection and correction.
• Measure and analyse all data related to Quality and the Environment in order to maintain continuous improvement in the organization.
• Commitment to products marketed and developed for the prevention of pollution in all phases of the process.
• Commitment of the whole organization with the prevention of pollution and protection of the environment.
• Application of all legal requirements relating to the provision of the service and distribution of products, as well as those that the organization subscribes voluntarily.
• Develop programmes for the improvement of products and services provided with regard to their technological, environmental and quality aspects.
• Instruct, motivate and involve all staff in the management and development of the Quality and Environmental System implemented.

To implement this Quality and Environmental Policy, PRIM’s management is based on the following directives and standards:

• Council Directive 93/42/EEC concerning medical devices.
• UNE-EN-ISO 13485:2016. Medical devices. Quality management systems. Requirements for regulatory purposes.
• UNEUNE-EN ISO 14001: 2015 Environmental Management System.

This Policy is reviewed at least once a year and updated when warranted by changes made.

This policy therefore provides the framework for establishing and reviewing the environmental objectives and targets of the management system.

PRIM Management shows its commitment through this communication and is responsible for the understanding, implementation and maintenance of the system at all levels of the organization.

(*) Document extracted from PRIM’s Quality and Environmental Manual, revision 17 October 2017, section 5.3.