|“Innovation and quality is our company philosophy”||
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:
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:
In order to implement these quality and environmental management objectives, PRIM carry out their management based on the following standards and directives:
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.