The objective of the Quality Management System of TERRATS MEDICAL S.L. is to establish the criteria through which our activities must be developed, in order to:
- Satisfy the requirements, both to our clients, as well as meet legal requirements, and adhering to standards that are applicable to us: Directive 93/42 / CEE on Medical Devices and the Standards UNE EN ISO 9001: 2015 and UNE EN ISO 13485: 2016, SOR 98 282; MHLW MO169:16; 21 CFR 820.20(b),
- Detect opportunities for improvement and undertake actions aimed at optimizing the operation of our company.
- Define the context of TERRATS MEDICAL S.L. by evaluating the weaknesses, threats, strengths and opportunities, and respond accordingly.
- Identify the risks to TERRATS MEDICAL S.L., by analysing, assessing, and treating those that are considered most significant.
Consequently, the Management of TERRATS MEDICAL S.L. commits to:
- Review/ Modify / Define the Quality Objectives by providing the resources required to achieve them.
- Design and maintain management by processes, in which we will measure their effectiveness.
- Review the adequacy and suitability of the human and material resources to achieve the conformity of our products and, as to the extent possible, maintain a high level of satisfaction with our customers.
- Motivate all our staff to comply with the provisions of our Quality Management System, as this is a fundamental element to maintain / improve our good image as a company.
- Apply our Quality Management System as an additional business management tool, periodically reviewing its implementation and effectiveness and establishing the mechanisms for its Continuous Improvement.