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Quality

QUALITY POLICY

RAFINT is committed to the continuous improvement of its processes, focusing on fulfilling the explicit and implicit requirements, needs and expectations of its customers by delivering solutions that will:

  • Enable clients to offer safe and effective regulated products to the Latin American and Caribbean markets in a timely manner.

  • Ensure clients comply with applicable regulatory and legal requirements, while ensuring tailoring solutions to  meet the business needs and fair interests of the companies we serve.

  • Help clients maximize the commercial lifespan of their products.

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RAFINT is committed to:

  • Implementing and maintaining a Quality Management System in accordance with  the ISO 9001:2015 international standard.

  • To train staff in the aforementioned areas and in their daily work, increasing their skills, as we consider them to be the most valuable asset of our organization.

  • Comply with the applicable national legislation in force, regulatory standards of the markets in which these products are distributed (Latin America and the Caribbean) and others to which RAFINT subscribes.

  • Reaffirming as an essential value that no goal justifies exposing customers, suppliers, collaborators, visitors and other interested parties to uncontrolled risks.

 

RAFINT's upper management assumes its leadership to ensure the communication and effectiveness of this policy at all levels of the organization in the pursuit of excellence in its operations, always committed to the continuous improvement of its quality management system, ensuring its effective implementation and seeking to increase its efficiency.​

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The Quality Policy document is available for download here (in Spanish).

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SCOPE OF THE QUALITY MANAGEMENT SYSTEM (QMS)

The QMS applies to the regulatory services to regulatory approvals required to achieve and maintain the commercialization of regulated health products throughout their lifecycle.

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The following sections of ISO 9001:2015 are out of the scope of the QMS:

  • 8.3 Design and Development of Services ISO 9001:2015
    RAFINT's QMS declares the requirements of this section as non-applicable because our COMPREHENSIVE REGULATORY AFFAIRS SOLUTIONS are based on the legal regulations applicable in the different countries of the region.

  • 8.5.1 f) Control of Production and Service Provision ISO 9001:2015
    This section is not applicable since all our services are validated according to the requirements previously agreed upon with clients and the applicable legal regulations in force.

  • 7.1.5.2 Measurement Traceability
    This section is not applicable because, due to the nature of our activities, it is not necessary to use measuring equipment that requires calibration or verification with traceable standards.

 

RAFINT ensures that its Quality Management System is aligned with the requirements of the ISO 9001:2015 standard, excluding only those sections that are not relevant to the nature of its operations.

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RAFINT Scope of the Quality Management Sytem Policy is available for download here (in Spanish).

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