QUALITY


MITELOS QUALITY POLICY

 

Mitelos Bioscience S.L (Mitelos) is a private, dynamic and independent pharmaceutical company that designs, develops, control of manufacture, distributes to different countries through other pharmaceutical companies and the health sector, and performs post-marketing follow-up of Medical Devices and Food Supplements within selected areas of interest.

 

Mitelos has implemented and maintains a Quality Management System based on the requirements of EN ISO 13485: 2016 whose certification has the following scope:

 

DESIGN AND CONTROL OF MANUFACTURE OF NON-STERILE LIQUIDS FOR OTIC APPLICATIONS

 

Mitelos considers Quality as an essential factor, both for its products and its services. That is why a MITELOS QUALITY POLICY has been created applicable to the purpose of the organization so that it is fulfilled by the Company's employees and companies that work on its behalf.

 

The general guidelines that, in relation to Quality, governing Mitelos are:

 

  • Ensure that the products provided to Clients are safe, reliable and comply with the applicable specifications, standards and applicable regulation.
  • Maintain a close collaboration with our distributors giving continuous advice on our products.
  • Obtain the maximum satisfaction of Clients, through the service offered, as well as the quality of the products supplied.
  • Maintain permanent contact with Clients and suppliers, collaborating together to the design and improve of our products.
  • Promote a good collaboration and mutual benefit with subcontracted companies and with our Clients.
  • Establish actions and programs aimed at preventing, and not only at applying corrections after detecting any problem.
  • Promote efficient internal and external communication within the scope of the Quality Management System.
  • That all those involved in the organization knows the Policy and applies it every day, with the commitment on the part of everyone to comply with the requirements and maintain the effectiveness of the Quality Management System.
  • The Management is committed to maintaining the effectiveness of the Quality Management System and providing the necessary resources and training to promote the maintenance of the effectiveness of the Quality Management System.
  • The Management commits to comply with the regulatory requirements and with the requirements of EN ISO 13485: 2016.
  • Establish quality objectives consistent and measurable with the Quality Policy.

 

To that aim, the Mitelos Management commits to review this Policy once a year for its continued adaptation.

 

EN ISO 13485: 2016 Certification