Quality and Environmental Policy

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, a company engaged in the manufacturing of orthotic and orthopaedic products, as well as in the distribution and technical service of medical devices, also committed to the manufacturing, distribution and after-sales service for rehabilitation and physiotherapy devices, declares 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 environmentally friendly product, by involving in these processes every company department and their personnel.

PRIM SA Quality and Environmental Management System complies with all applicable requirements described in the EN ISO 13485:2016 and EN ISO 14001:2015 standards.

The certified scope applies to:

• Design, manufacturing and distribution of orthoses, orthopaedic devices and rehabilitation and physiotherapy equipment.
• Distribution and technical support of medical and non medical devices.
• Grouping of CE marked medical devices for procedure packs.

The guidelines and general objectives related to quality assurance and environmental management, to which PRIM is 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 and consistent with it.

Our Quality and Environmental Management guidelines are:

• Commitment to meet the requirements of the interested parties and maintain the efficiency of both QR and EM systems.
• Make sure that the products and services provided to the 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 the detection and correction of non-conformities 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.
• Commitment to the products marketed and developed for the prevention of Pollution at all stages of the process and respect for the environment. Commitment from the entire organization with pollution prevention and environmental protection.
• Comply with the applicable statutory and regulative requirements related to service and sales, and also with the specific relevant to the context of the organisation and stakeholders.
• 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 carry out their management based on the following standards and directives:

• Council Directive 93/42 EEC concerning medical devices.
• EN-ISO 13485:2016. Medical devices. Quality Management Systems Requirements for regulatory purposes.
• EN ISO 14001:2015. Environmental management Systems. Requirements with guidance for use.

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 and it’s appropriate to the purpose and context of the organization.

This Policy will be made available to interested parties by defining the channels of communication.

PRIM’s Management shows its engagement by means of this statement and takes responsibility for its understanding, implementation and continuous updating at every level of the company.

(*)Document excerpted from PRIM Quality Manual, 18th revision Abril 2019, paragraph 5.3.