Carried out by:
Pilar Aranda Aranda
Quality Technician
Date and signature: 02/01/2023 Firma Pilar Aranda
Reviewed by:
Elena González Rodríguez
Quality Manager
Date and signature: 02/01/2023 Firma Elena González
Approved by:
José Luis López Sánchez Pascuala
CEO
Date and signature: 02/01/2023 Firma José Luis López

The ultimate goal of Insulcloud's Quality Policy is to supply Health Products that meet customers' expectations, requirements and delivery time.

Insulcloud's Board Committee considers Quality essential in order to achieve excellence in its endeavors. It works daily to fulfill its commitment to society, which has been a key element of the company culture since the foundation, both internally, especially in the workplace, and in aspects manifest to society as a whole and to its clients. Insulcloud offers solutions which meet the highest quality standards at a clinical level, with great respect to the environment and promoting awareness regarding data protection processed by the company.

Insulcloud's main objectives are:

  • Outline a Quality System, documented in written procedures, specifications, technical documentation, records, etc., applying the available tools (such as risk management) when necessary, and ensuring that this system is understood and implemented throughout the organization.
  • Provide the company with the necessary human and technical resources, adequate space and premises, convenient equipment and services, approved instructions and documents, to ensure the quality of the products and to successfully carry out the Quality Policy, avoiding customer complaints and achieving the highest productivity.
  • Create a favorable climate for the promotion of Quality, motivating and training staff to follow procedures correctly.
  • Ensure that Regulation 2017/745, UNE-EN-ISO 13485:2018 and 21 CFR 820 are complied with, as well as any other Quality standard that may be applicable due to company policy or current needs, thus guaranteeing that the products are manufactured, controlled and distributed appropriately, to achieve quality levels for their intended use.
  • Ensure that all the people who make up the Insulcloud, S.L. staff clearly understand the responsibilities assigned to them.
  • Develop products for patient monitoring systems and improvement of quality of life in different diseases, with advanced technology and constant innovation.
  • Provide products and services that meet customer requirements, needs and expectations, as well as applicable legal requirements, addressing risks and opportunities, so that a firm commitment to continuous improvement is maintained.
  • Lead a group made up of experts in the Bioscience sector, knowledgeable about cutting-edge techniques and tools and with great pride in belonging.
  • Promote innovation, research and work under the philosophy of continuous improvement.

The effectiveness of the Quality Management System (QMS) depends on the support and teamwork of all employees. Understanding the importance of daily tasks that each of them performs and how the cooperation of all of them makes it possible to achieve global objectives.

General Management assumes the responsibility of defining, introducing and supporting this Quality Policy, which has taken the Quality Manual and the Quality Management System of the company as its source.

The role of the Quality department is essential, for it is responsible for monitoring that all applicable regulatory requirements are met, as well as ensuring the suitability and effectiveness of the Quality Management System of Insulcloud S.L.; controlling in this way that the processes are efficient, the products are insurance and the patient's safety is guaranteed.

In addition, General Management defines the specific objectives of the company and their compliance with what is defined in the current Quality policy, appointing each department with the necessary authority and responsibility, as well as providing the human, technical and economic resources needed for the fulfillment of these objectives. General Management assumes compliance with the maintenance of the Quality Management System, and will evaluate the need for changes in this system, including the quality policy and objectives; thus providing a framework to be taken as a reference, which will be for its continued adaptation.