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Quality and Environmental Policy


PRIM, a company engaged in the manufacturing of orthotic and orthopaedic products, as well as in the distribution and technical service of medical devices together with ENRAF NONIUS IBÉRICA, a company devoted to the manufacturing, distribution and after-sales service for rehabilitation and physiotherapy devices, declare that quality and the respect for the environment are priorities in the development of their activities, in order to meet customer needs anytime, by offering them a competitive and environmental friendly product, by involving in this process every company department and their personnel.

a) PRIM SA Quality Management System complies with all applicable requirements described in the EN ISO 13485:2013. The certified scope applies to:
 Design, manufacturing and distribution of orthotic and orthopaedic devices.
 Distribution and technical support of medical and non medical devices.
 Grouping of individually CE marked medical devices for procedure packs.

b) ENRAF NONIUS IBERICA, SA Quality Management System complies with all applicable requirements described in EN ISO 13485:2013. The certified scope applies to:
 Manufacturing, distribution and technical service of medical devices.

c) ENRAF NONIUS IBERICA, SA Environmental Management System includes every applicable requirements described in the EN ISO 14001:2004. The scope of the Environmental Management certification applies to:
 Distribution and Technical Service of medical devices at its headquarters on F Street, nº 15, Móstoles (Madrid).

The guidelines and general objectives related to quality assurance and environmental management, to which PRIM and ENRAF NONIUS IBERICA are committed to, are unified and described in their Quality and Environmental Policy Statement, which is defined by Head Direction, as part of the general policy of the company being consistent with it.

Our Quality and Environmental Management guidelines are to:

• Make sure that the products and services provided to our customers are safe, reliable and meet all the specifications, standards and codes which apply to them.
• Work and collaborate closely with customers in the improvement of our products and services.
• Settle actions and programs not only focused on non conformities correcting or detection but aimed at prevention.
• Measure and analyse all the data related to Quality and Environment processes in order to attain and maintain a continuous improvement in the organization.
• Develop and market products reducing and controlling pollution in every stage of the process.
• Engage our Technical Service to prevent the environmental pollution arised from its activities.
• Comply with the applicable statutory and regulative requirements related to service and sales, and also with those subscribed on a voluntary basis.
• Develop projects in order to improve our products and services, from a technological, environmental and quality point of view.
• Educate, motivate and involve the entire staff working on behalf the company in the management and development of the implemented Environmental and Quality Management System.

In order to implement these quality and environmental management objectives, PRIM and ENRAF NONIUS IBERICA carry out their management based on the following standards and directives:
• Council Directive 93/42 EEC concerning medical devices.
• UNE EN ISO 14001:2004. Environmental management Systems. Requirements with guidance for use.
• UNE-EN-ISO 13485:2013. Medical devices. Quality Management Sistems Requirementes for regulatory purposes.

This statement will be reviewed every year and will be updated whenever the changes require a new document.

This statement provides the framework to settle and review the environmental objectives and targets of this management system.

Both companies, PRIM and ENRAF NONIUS IBERICA, show their engagement by means of this statement and take responsibility for its understanding, implementation and continuous updating at every level of the company.

(*)Document excerpted from PRIM/ENRAF Quality Manual, 12th revision, paragraph 5.3.


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